European Geriatric Medicine 6 (2015) 134–150 Available online at ScienceDirect www.sciencedirect.com Research paper Non-pharmacological interventions as a best practice strategy in people with dementia living in nursing homes. A systematic review E. Cabrera *, C. Sutcliffe, H. Verbeek, K. Saks, M. Soto-Martin, G. Meyer, H. Leino-Kilpi, S. Karlsson, A. Zabalegui On behalf of the RightTimePlaceCare Consortium1 School of Health Sciences TecnoCampus, University Pompeu Fabra, Avda. Ernest Lluch 32, 08332 Mataró, Barcelona, Spain A R T I C L E I N F O A B S T R A C T Article history: Received 3 April 2014 Accepted 2 June 2014 Available online 26 June 2014 Background: Two-thirds of nursing home residents suffer from dementia and there is a need for effective and efficient interventions with meaningful outcomes for these individuals. This study aims to identify current best practices in non-pharmacological interventions in nursing homes. Methods: A systematic literature review was conducted, following the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) declaration guideline. Studies and Randomized Controlled Trials (RCT) evaluating non-pharmacological interventions focused on improving the Quality of Care (QoC) and/or Quality of Life (QoL) of people with dementia (PwD) living in nursing homes were included. For individual study evaluation, the Cochrane Collaboration risk of bias assessment tool was used. Results: A total of 31 articles were included and five main categories emerged: psychosocial and educational, physical activity, sensorial therapies, staff-focused interventions and complex interventions. Psychosocial interventions were the most exhaustively studied and evaluated interventions. Few studies related to physical therapy were identified and they did not provide enough evidence of their effectiveness. Therapeutic touch was revealed to have positive effects on residents with dementia. Conclusion: Psychosocial interventions have been shown to have the potential to improve the QoL and QoC of people with dementia in nursing homes. Before implementation of the intervention, it is recommended that activities are adjusted according to residents’ characteristics and external factors controlled to achieve effectiveness and to structure a well-designed intervention. However, there is not enough evidence to support the effectiveness of non-pharmacological interventions in general. Further well-designed research is needed on non-pharmacological interventions in nursing facilities. ß 2014 Elsevier Masson SAS and European Union Geriatric Medicine Society. All rights reserved. Keywords: Non-pharmacological interventions Best practice Dementia Nursing home Systematic review 1. Background Nursing homes (NH) provide medical attention to people who do not require hospitalization but cannot live alone. The majority of residents are elderly and evidence shows that two-thirds suffer from some type of dementia [1]. Dealing with the consequences of this disease: neuropsychiatric symptoms, functional difficulties, cognitive problems, deterioration of daily living activity skills, etc., * Corresponding author. E-mail addresses: [email protected] (E. Cabrera), [email protected] (C. Sutcliffe), [email protected] (H. Verbeek), [email protected] (K. Saks), [email protected] (M. Soto-Martin), [email protected] (G. Meyer), Helena.leino-kilpi@utu.fi (H. Leino-Kilpi), [email protected] (S. Karlsson), [email protected] (A. Zabalegui). 1 University of Witten/Herdecke (DE): Gabriele Meyer PhD, RN, professor (scientific coordinator, WP 1 leader), Astrid Stephan MScN, RN, Anna Renom Guiteras, geriatrician, Dirk Sauerland Dr.rer.pol., professor (WP 4 and 6 leader), Dr Ansgar Wübker, Patrick Bremer dipl. oec. Lund University (SE): Ingalill Rahm Hallberg, professor (WP 2 leader); Ulla Melin Emilsson, professor; Staffan Karlsson, PhD, Christina Bokberg, MSc, Connie Lethin, MSc. Maastricht University (NL): Jan P.H. Hamers, PhD, RN, professor (WP 3 leader); Basema Afram, MSc; Hanneke C. Beerens, MSc, RN; Michel H.C. Bleijlevens, PhD, PT; Hilde Verbeek, PhD; Sandra M.G. Zwakhalen, PhD, RN; Dirk Ruwaard, MD, PhD, professor. University of Manchester (UK): David Challis, professor (WP5 leader); Caroline Sutcliffe MSc; Dr David Jolley; Sue Tucker, MSc, RN; Dr Ian Bowns; Brenda Roe, professor; Alistair Burns, professor. University of Tartu (EE): Kai Saks, MD, PhD, professor (WP 5 leader); Ene-Margit Tiit, PhD, professor; Jelena Leibur, MD, MBA; Katrin Raamat, MA; Angelika Armolik, MA; Teija Tuula Marjatta Toivari, MA, RN. Gerontôpole, University of Toulouse (FR): Dr Maria Soto; Agathe Milhet; Dr Sandrine Sourdet; Sophie Gillette; Bruno Vellas, professor. University of Turku (FI): Helena Leino-Kilpi, PhD, RN, professor; Jaana Koskenniemi, MNSc, RN, researcher; Riitta Suhonen, PhD, RN, professor; Matti Viitanen, MD, PhD, professor; Seija Arve, PhD, RN, docent; Minna Stolt, PhD, podiatrist; Maija Hupli, PhD, RN. – Fundació Privada Clinic per la Recerca Biomedica, Hospital Clinic of Barcelona (ES): Adelaida Zabalegui PhD, RN (WP 5 leader); Esther Cabrera PhD, RN (Tecnocampus Mataró), Montserrat Navarro PhD, RN Ester Risco MNSc, RN; Carme Alvira MScN, RN; Marta Farre MScN, RN; Susana Miguel MScN, RN. http://dx.doi.org/10.1016/j.eurger.2014.06.003 1878-7649/ß 2014 Elsevier Masson SAS and European Union Geriatric Medicine Society. All rights reserved. E. Cabrera et al. / European Geriatric Medicine 6 (2015) 134–150 is complicated [2,3]. It is necessary to define management strategies and improve quality of care (QoC) and quality of life (QoL) of dementia sufferers (PwD) [4]. Health professionals need to be aware of what constitutes best practice in this population and setting [5]. There is a need for effective and efficient interventions with meaningful outcomes. The effectiveness of the pharmacological intervention approach is moderate at best and the potential for side effects is substantial. Studies indicate non-pharmacological interventions use a wide range of approaches and have demonstrated effectiveness in treating behavioral and psychological symptoms with no adverse effects [6]. A recent meta-analysis showed how non-pharmacological interventions reduced the frequency and severity of dementia symptoms [7]. However, there is scarce evidence of positive results in residential settings [8]. This review is part of an extensive European research project called ‘RightTimePlaceCare’ (RTPC) – (HEALTH-F3-2010-242153 supported by the European Commission in the 7th framework program). The RTPC project includes eight European countries: Germany (coordinator), England, Estonia, Finland, France, Spain, Sweden and The Netherlands, and aims to develop best practices in European dementia care [9]. To identify current best practices in non-pharmacological interventions, a systematic literature review was conducted. The concept of best practice (BP) is defined as ‘‘a program, activity or strategy that has the highest degree of proven effectiveness supported by objective, comprehensive research and evaluation’’ [10]. BP can improve QoC and QoL of PwD. We considered nonpharmacological interventions as treatment modalities to decrease pain, improve mobility and QoL, enable the patient to lead a normal social life and prevent health problems. The research question underlying the study was: Which non-pharmacological interventions are considered best practice (improving QoC and/or QoL) for people with dementia living in long-term care facilities? 2.2.2. Exclusion criteria Systematic review and meta-analysis. 2.3. Data extraction strategy Data extraction was independently carried out by the same two authors (AZ, EC). Information was organized from each study and included: study design (sample size, randomization, blinding, and study follow-up), patients’ profiles, intervention characteristics, variables, results and outcomes. 2.3.1. Critical analysis of study quality For individual study evaluation the Cochrane Collaboration risk of bias assessment tool was used [12], describing the potential risk of study design bias. This provides a framework for assessing a trial and helps researchers to judge effectiveness. The following study design aspects were evaluated in every RCT for potential bias risk: method of sequence generation (randomization); allocation concealment; rationale for blinding of participants, personnel and outcomes; incomplete outcome data; selective outcome reporting; other potential sources of bias such as conflict of interest. Each item was rated as being potentially at low-risk (‘‘Yes’’), high-risk (‘‘No’’) or (‘‘?’’) unclear. All items were rated in duplicate by two members of the research team until agreement was reached. 2. Methods 3. Results This systematic review followed a pre-specified protocol (available on request) developed using the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) declaration guideline [11]. 3.1. Study selection 2.1. Search strategy The search was performed in two phases. The first at the beginning of 2012 and the second in 2013 in MEDLINE, (accessed through PubMed), CINAHL and the Cochrane Methodology Register (accessed through the Cochrane Library). One researcher performed the search under the supervision of an expert librarian. The search strategy used the key terms: ‘‘Alzheimer disease’’ OR ‘‘dementia’’ AND ‘‘patient care’’ OR ‘‘nursing home’’ OR ‘‘long-term care’’ AND ‘‘Non-pharmacological interventions’’. 2.2. Eligibility criteria 2.2.1. Inclusion criteria Studies evaluating one or more non-pharmacological interventions focused on improving the QoC and/or QoL of PwD living in nursing homes; Randomized Controlled Trials (RCT); studies in the English language published in peer review journals; articles published from 1990 to 2013. 135 The screening process is summarized in Fig. 1. The research yielded 2911 articles. One thousand one hundred and twenty were in the English language and published between 1990–2013. Duplicated studies were excluded, leaving 830 articles. To ensure search accuracy, two authors independently examined all titles and abstracts, producing a sample of 193 studies. The same two researchers independently reviewed the full text of the selected articles and approved inclusion. Any lack of agreement was resolved by consensus, leaving a final sample of 31 RCTs. 3.1.1. Study characteristics Thirty-one RCTs met the inclusion criteria [13–38,40–44] and five main intervention categories emerged (Table 1): psychoeducational [13–21], physical activity [22–25], sensorial [26–34], staff-focused [35,36,37,38,40] and complex [41–44] (Table 2). Nineteen studies were two-arm RCTs [14,15,17–19,21–23,25,26, 29–32,35,38,40,41,43] and 12 were three-arm or more [13,16,20, 24,27,28,33,34,36,37,42,44]. Six studies were double-blind. Not all RCTs conducted longterm follow-up. Follow-up of between 0–1 month post-intervention was done in 4 trials [16,31,32,34], 1–3 months in 3 trials [14,19,38], 4 months in one trial [42] and six months in 3 studies [23,25,36]. All studies focused on managing the consequences of dementia in PwD care homes, 4 addressed to care home staff [35–38] and 3 studies for family members [17,19,40]. E. Cabrera et al. / European Geriatric Medicine 6 (2015) 134–150 136 and reminiscence therapy. In this review, three distinct intervention types were identified: individual activities [13–17]; group activities [18,19]; and reminiscence therapy [20,21]. Records identified through database searching (n=2911) Records after applied inclusion criteria (n=1120) Duplicates (n=290) Results after duplication extraction (n=830) Articles screened on the basis of the title and abstract Final sample (n=193) Full-text articles assessed for eligibility Articles included in the review (n=31) Fig. 1. Flow diagram of search strategy process. 3.2. Intervention effect The review was done by categories. 3.2.1. Psychosocial and educational interventions Psychosocial interventions most frequently mentioned in the literature were caregiver interventions, multi-sensory stimulation 3.2.1.1. Individual psychosocial and educational activities. Of the 5 RCTs evaluating individualized psychosocial and educational activities, one carried out in 2000 consisted of a walking-talking program developed in pairs but assessed individually, to improve communication, ambulation and functioning [13]. This was compared to a conversation-activity group and a no-treatment group. Non-significant differences between groups were obtained. Authors observed that participants with moderate cognitive impairment had higher outcome scores than those with more severe dementia. Two behavioral interventions to reduce disruptive behaviors and improve affect were tested by Beck et al. (2002) [14]. The first included activities of daily living (ADL) for 45–60 minutes. The second assessed self-esteem, safety and security, and personal identity and cognitive understanding. A third group had a combination of both. The three treatment groups showed positive effects but disruptive behavior was not reduced with respect to controls. An intervention to decrease agitation in residents with moderate dementia, the Balancing Arousal Controls Excesses (BACE) intervention, was tested on 36 participants and compared with a no-treatment group [15]. This intervention controlled daily activity schedules to obtain a balance between residents’ high- or low-arousal states. The effect size was moderate and suggested the BACE intervention was effective (average change 8.43 points pre to post-test, effect size of 0.7). A 4-arm RCT evaluated the effects of activities in the ‘‘needdriven dementia-compromised behavior model’’ on behavioral symptoms [16]. There were four groups: functional level activity (FL), personality style of interest activity (PSI), functional level/ personality style mixed (FL + PSI), and a control group. Participants in the FL group became less engaged compared with the other 2 groups, PSI group participants suffered less agitation and FL + PSI subjects demonstrated less positivity. Table 1 Non-pharmacological interventions for people with dementia living in nursing homes. A. Psychosocial and educational interventions [16–24] A.1. Individualized activities A.2. Group activities A.3. Reminiscence therapy B. Physical activity interventions [25–28] B.1. Individual and group exercise C. Sensorial interventions [29–37] C.1. Light therapy C.2. Music therapy C.3. Sensory stimulation C.4. Therapeutic touch D. Staff-focused interventions [38–41,43] D.1. Training sessions, care management D.2. Emotion-oriented care E. Complex interventions [44–47] Multidisciplinary interventions Addresses the individual, social and environmental aspects of a person’s life. Can prevent or minimize the disability associated with neurological impairment Provides stimulation and socialization that help to slow physical and cognitive deterioration Aims to increase levels of well-being and provides pleasure and cognitive stimulation. RT involves helping a person with dementia to relive past experiences, especially those that might be positive and personally significant Therapeutic exercise developed in groups and physical activity program focused on the individual Aims to improve fluctuations in diurnal rhythms that may account for night-time disturbances and ‘sundown syndrome’ (recurring confusion or agitation in the late afternoon or early evening) in people with dementia Aims to involve engagement in a musical activity (e.g., singing or playing an instrument), or merely listening to songs or music Multi-sensory approaches usually involve using a room designed to provide several types of sensory stimulation such as light (often in the form of fibre optics which can move and be flexible), texture (cushions and vibrating pads), smell and sound. The use of these resources is tailored to the individual and therefore not all of the available forms of stimulation may be used in one session It is a technique in which the hands are used to direct human energy for healing purposes. There is usually no actual physical contact Provides training for staff in nursing homes and consists of programs on how best to manage residents with dementia. The training imparts knowledge about dementia care components Aims to improve emotional and social functioning, and ultimately the quality of life, of persons suffering from dementia by supporting them in the process of coping with the cognitive, emotional and social consequences of the disease and by linking up with individual functional possibilities Interventions where different health and social professionals are involved Table 2 Characteristics of included studies. Interventions Author and year Sample Randomized Blind F-Up Participants characteristics Objective Intervention Results 3-arm RCT n = 74 EG1 = 25 EG2 = 30 CG = 19 Yes No No Alzheimer diseases; living in NH, MMSE <20; ability to walk 5 meters with or without assistance To investigate the effects of a walking/ talking program on residents’ communication, ambulation, and level of function when there were two residents to one care provide (2:1) The walk and talk intervention (EG1) consisted of 30 minutes of walk and talk session 5 times a week for 16 weeks Participants in the talk intervention (EG2) received a session of 30 minutes of conversation sitting with the therapist 5 times a week for 16 weeks Participants in the control (CG) group did not receive any treatment Beck et al., 2002 [14] 2-arm RCT n = 127 EG1 = 28 EG2 = 29 EG3 = 22 CG1 = 29 CG2 = 19 Yes No Yes 1m 2m Patients with dementia; >65 years old; living in NH To test the effect of two interventions: (1) an activities of daily living and (2) a psychosocial activity intervention and (3) a combination of the two, in reducing disruptive behaviors and improving affect in nursing home residents with dementia Kovach et al., 2004 [15] 2-arm RTC n = 78 EG = 36 CG = 42 Yes Yes No Residents in NH; MMSE <15; with agitation by nurses report To test the effectiveness of the theoretically driven BACE (i.e. Balancing Arousal Controls Excesses) intervention in decreasing agitation in residents of long-term care with moderate or severe dementia Three intervention groups: (1) an educational intervention implemented during bathing, grooming, dressing and noon meal and tried to promoted cognitive and physical abilities (45– 60 min/day); (2) the PSA intervention contained 25 standardized modules with five psychosocial areas to meet psychosocial needs for communication, self-esteem, safety and security, personal identity and cognitive understanding of participants respecting their cognitive and physical abilities (15–30 min/day); (3) combination of ADL + PSA (90 min/day) Control groups consisted on: (1) placebo and (2) no intervention The BACE intervention consists of three phases: (1) patient assessment; (2) diagnose and plan a correction of the arousal imbalance; (3) implement a new activity schedule There were non-statistical differences between groups. Residents with moderate cognitive impairment had higher scores on social communication (P = 0.000), communication of basic needs (P = 0.000) and overall communication (P = 0.000) The subgroups did not differ significantly on ambulation; however there was a tendency for residents with moderate cognitive impairment to walk longer distance Results from the analysis of affect reported an increase on positive affect but not decreased negative affect. There were no significant results on reducing disruptive behaviors A. Psychosocial and educational A.1. Individual Cott et al., 2002 [13] Balancing time spent in higher and lower arousal states through manipulation of activity schedules is effective in decreasing agitation levels of people with dementia (P = 0.04) Results not generalizable E. Cabrera et al. / European Geriatric Medicine 6 (2015) 134–150 Study 137 138 Table 2 (Continued ) Interventions Study Sample Randomized Blind F-Up Participants characteristics Objective Intervention Results Kolanowski et al., 2011 [16] 3-arm RCT n = 128 EG1 = 32 EG2 = 33 EG3 = 31 EG4 (AC) = 32 Yes Yes 1 w after Residents in NH; MMSE < 24 >65 years old To test the main and interactive effects of activities derived from needdriven dementiacompromised behavior model for responding to behavioral symptoms in nursing home resident Participants were assigned one of four groups: (1) functional level (FL: activities tailored to their skill level but opposite their personality style of interest); (2) personality stile of interest (PSI); (3) FL + PSI: activities tailored to their functional skill level and personality style of interest and (4) active control (AC: activities functionally challenging and opposite their personality style of interest). All groups received 20 minutes twice per day five days each week for three consecutive weeks of activity Hanson et al., 2011 [17] 2-arm RCT n = 256 EG = 127 CG = 129 Yes Yes (NH) No Informal caregivers of people with dementia living in NH To test whether a decision-aid improves quality of decision-making about feeding options in advanced dementia Participants in EG received a structured decision-aid providing information about dementia, feeding options and the outcomes, advantages, and disadvantages of feeding tubes and assisted oral feeding, to take home and research assistants prompted them to discuss it with healthcare provide During the intervention participants in FL group became less engaged (P = 0.009), participants in PSI less agitation (P = 0.007), participants in FL + PSI demonstrated less passivity (P = 0.025). Agitation increased in AC (P = 0.046) and in FL + PSI (P = 0.003). Results compared with baseline scores to one week post-intervention, mood improved in the FL + PSI (P = 0.017), anxiety in FL group (P < 0.0001) but decreased in pleasure FL (P < 0.0001) and PSI (P < 0.001) Participants in EG group had significantly lower score on the Decision Conflict Scale than CG whom had usual care (P < 0.001). EG had higher mean knowledge scores than control (P < 0.001) Residents in EG were more likely to receive a dysphasia diet (P = 0.04) Fritsch et al., 2009 [18] 2-arm RCT n = 20 NH EG = 10 NH CG = 10 NH Yes No No Residents from a freestanding NHs with dementia special care units (SCUs) To assess the impact of a TimeSlips (TS) intervention, a group story telling program that encourages CE among PWDs and those who care for them The TS program (EG) involved groups of 10–12 residents once a week for 1 hour for 10 weeks The facilitators asked open-ended questions about a picture and recorded residents’ responses on pads of paper, making it clear that there were no incorrect answers. Facilitators then wove the response into a story, periodically reading it back to the participants as it progressed, to maintain the groups’ focus and enthusiasm. Participants were encouraged to participate in storytelling. The story was later transcribed and displayed to the residents A.2. Group Staff in the EG had greater social eye contact (P < 0.001), touch (P < 0.001) and verbal communication (P < 0.001). They also had less devalue attitudes to the residents (P = 0.013) and more positive views of these persons (P < 0.001) compared with the CG Residents in the EG reported challenging behaviors (P < 0.05), more general alertness (P < 0.05), fear or anxiety (P < 0.01) and sadness (P < 0.05) than the CG that reported a more neutral affect (P < 0.01) E. Cabrera et al. / European Geriatric Medicine 6 (2015) 134–150 Author and year Table 2 (Continued ) Interventions Study Sample Randomized Blind F-Up Participants characteristics Objective Intervention Results Ducharme et al., 2005 [19] 2-arm RCT n = 178 EG1 = 45 CG1 = 41 EG2 = 51 CG2 = 41 Yes No (CG) No Adult daughter primary caregivers of people with dementia living in a NH To test the persistent and delayed effects of an intervention program entitled ‘‘Taking care of myself’’ on selected mental health outcomes of daughter caregivers of a relative with dementia living in a long-term care setting Ten 90-minute weekly sessions for groups of six to eight caregivers. Discussion: (a) the empowerment of caregivers; (b) reframing, a coping strategy The program covers 6 themes: (1) feeling at ease when visiting my relative; (2) expressing my point of view to healthcare staff; (3) avoiding emotional torment; (4) dealing with small daily losses and being prepared for the ultimate loss of my relative; (5) identifying and calling upon my support network and community services; and (6) reorganizing my life after my relatives’ institutionalization and taking care of myself Successful effects in the EG were maintained at T3 in perceived availability of informal/ formal support, competence dealing with healthcare staff and reframing Control by self, perceived threat, role overload and perceived challenge was maintained in T2 but not in T3 More caregivers in both EG obtained successful outcomes for competence dealing with healthcare staff (P < 0.05), reframing (P < 0.05), and perceived availability of informal/ formal social support (P < 0.001) 3-arm RCT n = 60 EG1 = 20 EG2 = 20 CG = 20 Yes Yes No Patients with vascular dementia living in nursing homes facilities To evaluate the beneficial effect of the group reminiscence approach (GRA) in patients with vascular dementia on the aspect of cognitive and observed behavioral parameters Results did not demonstrate an improvement on cognitions and behaviors The authors concluded that non-pharmacological interventions including psychosocial ones can be tested in an objective and reproducible manner 2-arm RCT n = 102 EG = 51 CG = 51 Yes Yes No Residents from five facilities with dementia To test the hypothesis that structured group reminiscence therapy could prevent the progression of cognitive impairment Participants in the experimental group received 1 hour groupal reminiscence approach (GRA) once a week for 3 months and 1 hour session of reality orientation (RO) A second group of participants received a conversation sessions (SC) received 1 hour session of RO and conversation The third group was the control group (CG). Participants in the CG received support care Sessions were carried out among psychologist, speech therapist, occupational therapist, medical social worker, and nurse EG received eight group sessions of 60 min (one per week and 8-week period). Themes: first meeting, childhood experiences, older flavor of food, old style music, festivals, my family, younger age, my achievements A.3. Reminiscence therapy Ito et al., 2007 [20] Wang, 2007 [21] E. Cabrera et al. / European Geriatric Medicine 6 (2015) 134–150 Author and year No significant difference was found at the baseline in any demographic variables besides the length of the hospitalization (P < 0.01). 92 subjects completed the study. No statistically significant differences between the pre-test scores of the two groups relative of three variables (MGDS-SF, CSDD). Results demonstrated that the intervention affected cognitive and affective function as measured by MMSE and CSDD (P = 0.0015 and 0.026) 139 140 Table 2 (Continued ) Interventions Author and year Sample Randomized Blind F-Up Participants characteristics Objective Intervention Results 2-arm RCT n = 37 EG1 = 36 EG2 = 36 Yes No No Patients with dementia living in long-term care facility To evaluate the efficacy of a kitbased activity intervention compared to a time and attention control in reducing apathy and improving quality of life in 37 patients with dementia Results indicated an improvement on apathy in both groups ‘‘kit’’ (P = 0.055) and ‘‘one on one’’ (P = 0.007). Participants in control intervention ‘‘one on one’’ also improved on quality of life (P = 0.030). Analysis between groups reported no significant differences on apathy and quality of life Eggermont et al., 2009 [23] 2-arm RCT n = 66 EG = 34 CG = 32 Yes No Yes (6 weeks) Persons with dementia living in nursing homes. Mean age of participants was 84.59 years To examinate the effects of hand motor activity on cognition, mood and the rest-activity rhythm in older people with dementia Tappen et al., 2000 [24] 3-arm RCT n = 65 EG1 = 23 EG2 = 22 EG3 = 20 Yes Yes No Patients with Alzheimer living in longterm care facilities. Participants mean age 86.7 years To compare a combined walking and conversation intervention on functional mobility in nursing home residents with AD Two interventions were used: G1 ‘‘the Geriatrics Network Kit’’ (experimental intervention) that is a structured activity helpful to apathetic patients. It is an individualized intervention. Patients’ choice an activity of their preference (five types: geography, fun foods, farm animals, vegetables and musical instruments). Activities are classified in two degrees of difficulty (30 min). EG2 – ‘‘one on one’’ (time and attention control). The therapist introduces a question or talk about some of participant interests. The intervention is individualized and unstructured and last for a half of an hour Hand motor activity (6 weeks) by recreational therapists or psychology master students. Participants in the experimental condition (EG) received a program based on fingers movements: pinching a soft ball, handling a rubber ring, among others. Instructions were reinforced by an instructional video. Participants in the control condition (CG) received conversation on selfinterest without memory or verbal objective Three conditions were compared provided three times a week for 16 weeks: (1) walking; (2) conversation; and (3) walking + conversation (GE). Walking condition (W). Participants received 30 minutes assessment to delay fatigue three times a week for 16 weeks. Participants were encouraged to ambulate as far as possible. During the sessions, there were no conversation, researchers only answer questions. Conversation participants received 30 minutes of conversation treatment about topics of personal interest. Walking + conversation (WC); participants received walking and conversation simultaneously within the 30 minutes session B. Physical activity Politis et al., 2004 [22] Results revealed an improvement on mood domain postintervention (P < 0.01) but this effect was not found at followup. No significant differences were founded on memory domain, cognition or activity Results indicated a percentage decrease in distance walked in W (20.9%) and C (18.8%) groups. Participants in the WC group maintained their level of functional mobility (2.5%) E. Cabrera et al. / European Geriatric Medicine 6 (2015) 134–150 Study Table 2 (Continued ) Interventions Study Sample Randomized Blind F-Up Participants characteristics Objective Intervention Results Conradsson et al., 2000 [25] 2-arm RCT n = 191 EG = 89 CG = 99 Yes Yes Yes (6 m) >65 years, dependent on assistance with a MMSE score 10 or more living in residential care facilities To evaluate the effects of a highintensity functional exercise programme on depressive symptoms and psychological well-being among older people dependent in activities of daily living (ADL) and living in residential care facilities A high-intensity functional weight bearing exercise program developed by physiotherapists (PT) Exercises were based on functional tasks common in everyday life. Participants developed the exercise at a highest intensity Control group received a sitting activity developed by an occupational therapist (singing, watching films. . .) Sessions (29) in both groups were performed in groups (3 to 9 participants) and lasted 45 minutes over 13 weeks No statistically significant results were found on depression and well-being scores. However, participants with dementia in the exercise group had an improvement on wellbeing scores post-intervention (P = 0.03) An individualized and multifactorial intervention may be needed to influence depressive symptoms or well-being in this group of older people 2-arm RCT n = 15 EG = 8 CG = 7 Yes No No Residents with dementia To test the efficacy of a bright light therapy for agitated behaviors in dementia patients residing in longterm care BLT consisted of 1 hour per day of light exposure for 4 weeks. During the process, the patients kept their eyes open and were allowed to make other activities such listening to music, watching TV, eating. . . Control condition received a lower light dose Ancoli-Israel et al., 2003 [27] 3-arm RCT n = 92 EG1 = 30 EG2 = 31 EG3 = 31 Yes No No Patients with Alzheimer living in an institution To evaluate the effect of bright light therapy (BLT) on agitated behavior in patients with dementia living in a nursing home Dowling et al., 2013 [28] 3-arm RCT n = 70 EG1 = 29 EG2 = 24 CG = 17 Yes No No Persons with Alzheimer living in nursing homes. Average age 84 years To test the effects of morning or afternoon bright light exposure compared with usual indoor light on the presence, frequency, severity, and occupational disruptiveness of neuropsychiatric behaviors in NH Professionals that carried out the intervention were nurses There were three intervention conditions: EG1 – morning bright light; EG2 – evening bright light; EG3 – morning dim red light (control, placebo intervention) Treatment were applied Three experimental conditions were tested during 11 weeks: (1) morning bright light; (2) afternoon bright light Control group Participants in group 1 and 2 received the same dose of bright light All participants showed slight improvement in nocturnal sleep as well as in mean scores on the Behave-AD, but this were not statiscally significant Participants in the EG improved in nocturnal sleep from a mean of 6.4 to 8.1 hours/night. Differences with the CG were statistically significant (P < 0.05) Agitation and behaviors There were no differences among groups on agitation levels Participants in the morning bright light reported a delay in the acrophase of physical agitation (P = 0.028) Statistical analysis showed significant differences between groups for agitation/aggression when compared to control group (P = 0.032), depression/ dysphoria (P = 0.042), aberrant motor behavior (P = 0.021), and appetite/eating disorders (P = 0.011) There were significant differences between morning and afternoon light on agitation/ aggression scores at the end of the intervention. In both increased being greater in morning light group (P = 0.009) C. Sensorial C.1. Light therapy Lyketsos et al., 1999 [26] E. Cabrera et al. / European Geriatric Medicine 6 (2015) 134–150 Author and year 141 142 Table 2 (Continued ) Interventions Study Sample Randomized Blind F-Up Participants characteristics Objective Intervention Results Burns et al., 2009 [29] 2-arm RCT n = 48 EG = 22 CG = 26 Yes No No Persons with dementia living in nursing homes To assess the benefit of bright light therapy (BLT) on sleep disturbance on people with dementia living in a nursing home Professionals that developed the intervention are not described Two interventions were compared: (1) experimental (GE): bright light therapy; (2) control (GC): normal light Results indicated an improvement for participants in the EG in agitation post-intervention, but data were not statistically significant compared with the CG (P = 0.51). Behaviors increased in the CG but there were no differences between groups. In sleep duration, there were no differences between groups post-intervention 2-arm RCT n = 47 EG = 23 CG = 21 Yes No No People with dementia Documented history of agitation/aggression Residing in a NH To investigate the effect of music on agitated behaviors and anxiety in older people with dementia living in NH The intervention was a live group music programme delivered by two musicians. Each music session ran for 40 minutes, three mornings a week Involved 30 min of musician-led familiar song singing and 10-minutes of pre-recorded instrumental music for active listening 2-arm RCT n = 100 EG = 49 CG = 51 Yes No Yes (1 month) Persons with dementia <65 years living in nursing homes facilities To explore the effectiveness of group music intervention on agitated behavior in elderly with dementia and living in NH Participants in the experimental group (EG) received 12 sessions of group music intervention 30 minutes’ sessions a week for 6 weeks. The intervention was a modified version of Clair and Bernstein protocol (1990) carried out by therapists Participants in the control group (CG) performed usual daily activities The outcomes were measured by CMAI-SF (behavior disturbance instrument) and RAID (anxiety symptoms instruments) Scores for the music intervention group were lower than those reported by the reading group Analyses showed that there was a significant increase in the frequency of verbal aggression over time (P < 0.005) There was no evidence to indicate that the music programme was more effective to indicate that the reading group activities Agitated behaviors scores decreased in the EG compared with CG, differences were statistically significant (P < 0.001). At 1-month post-intervention, the positive effect was also statistically significant (P < 0.001). Results in physical non-aggressive behaviors revealed a statistically significant difference in the EG postintervention (P = 0.004) and at one month follow-up (P = 0.015). Results in verbal non-aggressive behaviors revealed a statistically significant difference in the EG postintervention (P = 0.010) and at one-month follow-up (P = 0.037). Results in verbal aggressive behaviors revealed a statistically significant difference in the EG post-intervention (P = 0.021) but not at follow-up C.2. Music intervention Cooke et al., 2011 [30] Lin et al., 2010 [31] E. Cabrera et al. / European Geriatric Medicine 6 (2015) 134–150 Author and year Table 2 (Continued ) Interventions Author and year Sample Randomized Blind F-Up Participants characteristics Objective Intervention Results C.3. Multi-sensor stimuli Baker et al., 2003 [32] 2-arm RCT n = 136 EG = 61 CG = 65 In three different countries (UK, Netherlands, Sweden) Yes No Yes Persons with dementia. Average age of participants was 81–83 years To assess whether multi-sensor stimuli (MSS) is more effective in changing the behavior, mood and cognition of older adults with dementia living in a NH Intervention was developed by nursing staff, occupational therapists or psychologist assistants Participants in the experimental group (EG) received multi-sensory stimulation (MSS) intervention Participants in the control group (CG) received eight activity sessions There were no differences between groups on behaviors, mood or cognition However, participants were less bored/inactive (P < 0.0001), enjoying (P < 0.01) and happy/content (P < 0.0001) after sessions C.4. Therapeutic touch Woods et al., 2005 [33] 3-arm RCT n = 57 EG1 = 19 CG1 = 19 CG2 = 19 Yes Yes No People with dementia living in special care units and in long-term care units. Participants were aged 67–93 years To examine the effect of therapeutic touch on the frequency and intensity of behavioral symptoms of dementia of people living in NH Three intervention conditions: (1) therapeutic touch (TT), experimental group (EG). Participants received TT on neck and shoulders. The intervention was conducted in the patient room and lasted 5–7 minutes for three days; (2) placebo therapeutic touch (PTT). Participants received a mimic treatment resembled TT; (3) control group (CG). Participants received routine care. 3-arm RCT n = 60 EG1 (TT) = 17 EG2 (ST) = 16 CG = 18 Yes Yes Yes (1 and 2 weeks) Persons with dementia, 65 years or older, living in longterm care facility To compare the effectiveness of therapeutic touch (TT), simulated therapeutic touch and usual care on disruptive behavior in people with dementia living in NH Participants received therapeutic touch once a day (5 days). The practitioners and volunteers spent approximately 30–40 min implementing their treatment. The five phases of non-touch. TT were administered by practitioners who had completed the advanced level of TT training: (a) TT per day/5 days; (b) ST treatment per day/5 days; and (c) usual care for 5 days Measurement of the resident’s agitation was taken: (a) 2 hours after each treatment; (b) 24 hours after the final treatment; (c) 1 week after the final treatment; and (d) 2 weeks after the final treatment Results indicated an improvement of behaviors statistically significant in the EG (P = 033) compared with the PTT and CG The experimental group was more effective in decreasing behavioral symptoms of dementia than usual care, while the placebo group indicated a decreasing trend in behavioral symptoms of dementia compared to usual care. There was no significant difference across the three groups in the incidence of physically aggressive (x2 = 2.28, P = 0.32) and verbally agitated behaviors (x2 = 1.99, P = 0.37). The intervention of TT did not have a greater influence on these behaviors than did the simulated TT intervention or the usual care group approach There were significant differences across the three intervention groups in the number of physically non-aggressive behaviors displayed during the 5 days (x2 = 5.98, P < 0.05). Post-intervention—Time 6 (24 hours after final intervention) to time 8 (2 weeks after final intervention). For all three behavior categories, there was no significant difference across intervention groups in the frequency of the behaviors (physically aggressive behaviors, x2 = 1.35, P = 0.51; physically non-aggressive behaviors, x2 = 1.37, P = 0.51; verbally agitated behaviors, x2 = 3.14, P = 0.21) Hawranik et al., 2008 [34] E. Cabrera et al. / European Geriatric Medicine 6 (2015) 134–150 Study 143 144 Table 2 (Continued ) Interventions Author and year Study Sample D. Staff-focused interventions D.1. Training sessions, psychosocial management Testad et al., 2-arm RCT n = 142 2005 [35] (PwD) EG = 55 CG = 87 (staff) EG = 14 CG = 22 Blind F-Up Participants characteristics Objective Intervention Results Yes Yes No Persons with dementia (PwD) living in nursing homes. Average 84 years To assess a stafftraining program intervention to reduce problem behaviors and the use of restraints in residents with dementia living in NH Participants in the experimental group (EG) participated in a six hours seminar focused on dementia, aggressions, problem behaviors, decision-making process and alternatives to restraints. A manual was developed to guide the seminar. Staff received 1 hour monthly guidance session for six months Participants in the control group (CG) received usual treatment There were three conditions: (1) dementia training program; (2) peer support program; and (3) control condition. EG1. Dementia training program plus peer support program, participants in E2. Dementia training program. GC were in a wait list control. Dementia training program consisted of eight 60– 90 minutes sessions of a combination of didactic and experiential learning. Program focused on skills to use in caring for residents with dementia especially on behaviors. Peer support program aimed to facilitate informal support on five peer sessions of 30– 60 minutes. Topics of the sessions were identified for the staff At the end of the intervention process, there was a significant decrease of the use of restraints in the EG compared with the CG (P = 0.017). However, agitation scores increased in the EG at six months (P = 0.017) and these scores were also higher than in the CG (P = 0.052) Davison et al., 2007 [36] 3-arm RCT G1: staff (90) EG1 = 29 EG2 = 35 CG = 26 G2: residents (113) EG1 = 35 EG2 = 46 CG = 32 Yes No Yes (6 m) 90 staff (nurses and unlicensed nursing assistants) 113 persons with dementia, mean age 85 living in nursing homes To evaluate the impact of an eightsession training program for aged care staff in managing dementiarelated challenging behaviors Kuske et al., 2009 [37] 3-arm RCT n = 321 EG1 = 107 EG2 = 104 CG = 110 Yes ? No Staff of residents with dementia To study the effectiveness of a nursing home stafftraining program designed to improve the interaction between residents with dementia and their caregivers The training program (EG1) was developed to increase the caregivers’ motivation and facilitate the transfer of their knowledge into practice. Participants in this group received 13 one hour sessions twice a week over 13 weeks Participants’ in the EG2 received 13 one hour sessions of relaxation training. The objective was to give caregivers the opportunity of relaxing for one hour while at work The CG did not receive any intervention Results showed no effects of training program and peer support on staff burnout at T2 and T3. Results on self-efficacy of dementia care showed a significant effect of training from T1 to T2 (P < 0.001) and at T1 to T3 (P < 0.05) compared with CG. A positive effect of peer support were found at T2 to T3 (P < 0.05). On nursing performance in GE1 increase by 32.2% at T2 and 32.6% at T3. Participants in GE2 increased 11.5% at T2 and 18.9% at T3. Participants in CG decreased 3.7% at T2 and increased 4.9% at T3 compared with T1 scores The impact on residents (frequency of behaviors) did not reach significance Participants in the EG1 increased their competence (P = 0.056) compared with the CG. In addition, the use of physical restraints in the EG1 decreased compared with EG2 and CG E. Cabrera et al. / European Geriatric Medicine 6 (2015) 134–150 Randomized Table 2 (Continued ) Interventions Study Sample Randomized Blind F-Up Participants characteristics Objective Intervention Results Deudon et al., 2009 [38] 2-arm RCT n = 306 EG = 174 CG = 132 Yes Yes Yes (12 weeks) Persons with dementia, older than 65 years living in nursing homes To evaluate the effectiveness of a staff education intervention to manage behavioral and psychological symptoms of dementia (BPSD) in older people with a diagnosis of dementia Professionals that conducted the intervention were ‘‘independent professionals’’ A staff education intervention and training program to manage behavioral and psychological symptoms of dementia (BPSD). Participants in the program received 90-minutes teaching session on BPSD and the use of four instruction cards that summarized practical advice. The first card contained a general guideline for the management of opposition, denial of care, aberrant motor activity, agitation, aggression, delusions, hallucinations and screaming. The second card explained how to decreased BPSD on daily care. The other two cards contained recommendations on nonpharmaceutical interventions as for example eating or bathing Participants in the experimental group reported less behaviors (P < 0.001) and agitation (P < 0.001) between baseline to week 8 Positive effect on agitation were maintaining at week 20 (P < 0.001) Participants in the control group did not have a significant evolution/outcome? On behaviors, but reported an increase on agitation (P < 0.05) at week 20 compared with the experimental group 2-arm RCT 8 NH EG 8 NH CG Participants: EG = 100 CG = 94 Yes No No Persons with dementia (PwD), age 65 or older living in nursing homes Nursing assistants (NA) To examine the effect of integrate emotion-oriented care on nursing home residents with dementia and nursing assistants Two nursing interventions were developed for this study: (1) usual care as control group (CG): working in accordance with the guidelines of the Model-Care plan of the Dutch association of Nursing Home Care; (2) offering integrated emotion-oriented care in combination with usual care. Wards included in the EG received training and supervision in the application of integrated emotion-oriented care for 9 months. The content of the training course was: basic training emotionoriented care for all staff members involved on the care, advanced course ‘‘emotion-oriented care worker’’ for five staff members on each ward, a training course ‘‘adviser emotion-oriented care’’ for one staff member per ward Central issues of the course were: the experiences of the residents, making a life story, being alert to how the past may affect the present and acknowledgement of the residents’ experiences. The course lasted 10 days during nine months Results for PWD: participants in the EG improved on maintaining an emotional balance (P = 0.04) and on maintaining a positive self-image (P = 0.04) Results for NA: participants in the EG reported less stress (P = 0.003) reactions than participants in the CG D.2. Emotion-oriented care Finnema et al., 2005 [39] E. Cabrera et al. / European Geriatric Medicine 6 (2015) 134–150 Author and year 145 146 Table 2 (Continued ) Interventions Author and year Sample Randomized Blind F-Up Participants characteristics Objective Intervention Results 2-arm RCT n = 44 EG = 33 CG = 22 Yes Yes No Geriatric patients with a mean age 83.4 years (65 to 95) and slight to moderate dementia living in long-term care geriatrics To compare the effect of a two different occupational therapy strategies in people with dementia living in NH Participants in the experimental group (EG) received functional rehabilitation (T1) and a reactivating occupational therapy program (T2) for 24 weeks. T2 was carried out twice a week during 1 hour in groups of 5–6 participants. Participants in T2 were stimulated by memory training, sensorimotor functions, and self-management Participants in the control group (CG) received a functional rehabilitation programme for 24 weeks, comprising functional occupational therapy, physiotherapy and speech therapy Christofoletti et al., 2008 [42] 3-arm RCT n = 54 EG1 = 11 EG2 = 12 CG = 14 SI SI (1) NO >65 years old Nursing home residents Dementia diagnoses To analyse the effects of two interventions on the cognition and balance of institutionalized elderly people with dementia Bellantonio et al., 2008 [43] 2-arm RCT n = 100 EG = 48 CG = 52 Yes No No Persons with dementia living in dementia assisted facilities. Mean age of participants was 81.1 to 83.4 To determine whether a multidisciplinary team intervention minimizes unanticipated transitions from assisted living for people with dementia To analyse the effects of two interventions on the cognition and balance of NH residents with dementia EG1. Interdisciplinary program with physiotherapy (on specific kinesiotherapeutic exercises that stimulated strength, balance and cognition such as concentrated attention, recognition, immediate memory, working memory and praxis), occupational therapy (group activities, by means of arts and craft activities) and physical education (walking sessions and exercises to stimulate strength, balance, motor coordination, agility and flexibility) 2 h sessions/5 times a week EG2: Physiotherapy (on specific kinesiotherapeutic exercises that stimulated strength, balance and cognition such as concentrated attention, recognition, immediate memory, working memory and praxis), 3 times a week CG: No motor intervention Experimental group (EG): intervention was developed by a multidisciplinary team: geriatrician and geriatric advanced practice nurse made recommendations on behaviors; physical therapist, evaluated physical function, gait and balance; dietician, evaluated nutritional status and diet recommendations; and a medical social worker, assessed guardianship issues, longterm planning and psychosocial adjustment of residents and family. The team met bimonthly and was available for consultation during the study period Control group (CG): consisted on usual clinical care. A team approach was not employed There was a significant effect on cognitive performance, psychological functioning, wellbeing and depression in both groups post-intervention Comparing two groups EG improved on cognitive performance at 12 weeks. At 24 weeks the EG improved in cognitive performance (P < 0.001), psychological functioning (P < 0.001), wellbeing (P < 0.001) and depression (P < 0.001) compared with the CG In EG1, there was a improvement in functional capacity (balance) when comparing with control group (P < 0.05) In EG2, there was an improvement, too when comparing with CG (P < 0.05) No changes were observed on the participant’s cognition E. Complex interventions Bach et al., 1995 [41] Results indicated that 55 residents experienced an unanticipated transition; differences between groups were no statistically significant. The intervention reduced the risk of transition, but results were not statistically significant E. Cabrera et al. / European Geriatric Medicine 6 (2015) 134–150 Study Results showed that agitation increases in UC and results persisted at follow-up (P = 0.03). On PCC agitation decreases post-intervention and at follow-up (P = 0.01). Participants in DCM had no statistical significant results (P = 0.77), but compared with UC participants in the DCM group reduced agitation at follow-up (P = 0.04) Participants in the DCM reduced antipsychotic drug doses compared with PCC postintervention and at follow-up. The DCM intervention was effective in reducing falls compared with UC (P = 0.02) and PCC (P = 0.03) Three conditions: (1) dementia care mapping (DCM). Two care staff were trained on DCM observation for 6 h per day for two days. Observation included positive aspects of well-being residents; (2) person-centred care (PCC) plans were implemented for 4 months 3. usual care (UC) To investigate the effectiveness of person-centered care and dementia care mapping compared with each other and with conventional dementia care and to examine whether either intervention can decrease need-driven dementiacompromised behaviors Persons with dementia living in nursing homes. Mean age of participants was 83– 85 years No n = 289 EG1 = 109 EG2 = 98 CG = 82 Chenoweth et al., 2009 [44] 3-arm RCT Yes Yes (4 months) Results Intervention Objective Participants characteristics F-Up Blind Randomized Sample Study Author and year Interventions Table 2 (Continued ) E. Cabrera et al. / European Geriatric Medicine 6 (2015) 134–150 147 One trial was identified as aiming to improve decision-making in 256 residents. This consisted of an audio or print decision-aid on feeding options in advanced dementia [17]. The intervention was compared with usual care. Experimental group participants (EG) had a significantly lower score on the decision conflict scale than controls (CG). Knowledge scores also increased and residents were more likely to receive a dysphagia diet. 3.2.1.2. Group psychosocial and educational activities or interventions. Two RCTs evaluated a psychosocial and educational group activity [18,19]. One study was addressed to informal caregivers [19], specifically adult daughters, and the other to the residents themselves [18]. The first study evaluated a program entitled ‘‘Taking care of myself’’ and consisted of 90-minute, weekly session group discussions about emotional issues. Experimental group participants achieved benefits in perceived availability of informal/formal support, and competence when dealing with healthcare staff and reframing. The second, a storytelling intervention entitled ‘‘TimeSlips’’ consisted of opened-ended questions administered to elicit responses used to generate new stories. Generally, the EG showed a positive response, social communication was enhanced and fewer negative attitudes were observed compared with controls [19]. 3.2.1.3. Reminiscence therapy. Reminiscence therapy is a common intervention in dementia care although too few high-quality or sufficiently robust studies were found. In our review, two RCTs explored group reminiscence [20,21]. It involves discussion of past activities, events and experiences with another person or group. A 3-arm RCT evaluated effects on behavior and cognitive symptoms [20]. The technique was compared with a conversation group and a support group. After authors identified some study design limitations, no improvements were obtained in any EG. However, another reminiscence group intervention [21] evaluated effectiveness in preventing cognitive impairment progression and enhancing affective function. The results showed improvement, compared with controls, in most variables including cognition and depression. 3.2.2. Physical activity No evidence for the effectiveness of physical interventions in improving QoC or QoL was found in our search. Five studies showed positive effects but did not reach statistical significance. One RCT tested a ‘‘geriatric network kit’’ intervention to reduce resident apathy as an individual, standardized structured one-toone individual, unstructured activity [22]. Apathy reduction and QoL improvement was observed in both groups but between group analysis revealed no significant differences. Results of hand motor activity revealed an improvement in the mood domain in the EG although the effect was not found at follow-up [23]. Evidence shows that combined programs [24] could significantly improve functional mobility when compared with single-activity only. Similar results were reported by Conradsson et al. (2000) [25] in a high-intensity functional exercise program seemed to have no influence on depressive symptoms and psychological well-being. 3.2.3. Sensorial interventions Several studies examined sensorial interventions. We identified four therapy types: light [26–29], music [30,31], multi-sensory stimuli [32], and therapeutic touch [33,34]. Nine trials met the inclusion criteria. This review revealed that therapeutic touch interventions seem to show the most positive effects. 3.2.3.1. Light therapy. Four RCTs tested the effect of Bright Light Therapy (BLT) on behavioral symptoms [26–29]. Two 3-arm RCTs compared the effect of morning BLT and afternoon/evening 148 E. Cabrera et al. / European Geriatric Medicine 6 (2015) 134–150 BLT with normal light [27,28]. The other two compared one single type of BLT with usual light [26,29]. When comparing the effect on dementia symptoms between morning and evening, no differences were found. Limited evidence was found of reduction in agitation and aggression among those receiving BLT [28,29]. 3.2.3.2. Music intervention. Two RCTs observed the effect of music on behavioral symptoms [30,31]. The first tested a live-music intervention on decreasing agitation and anxiety [30]. This was compared to a reading intervention. Results showed no significant differences in agitation and anxiety. Nonetheless, an experimental study [31] consisting of a group music-listening intervention showed a statistically significant decrease in agitated behavior scores in the EG at three time-points. 3.2.3.3. Multi-sensory stimuli interventions. One RCT identified a multi-sensory stimuli (MSS) intervention consisting of 8 standardized sessions. Effect was assessed through changing behavior, mood and cognition. Controls followed an exercise program [32]. No differences were found between groups in behaviors, mood or cognition. 3.2.3.4. Therapeutic touch. Therapeutic touch interventions were effective in decreasing behavioral symptoms. Two RCTs compared therapeutic touch (TT), with simulated therapeutic touch (STT) and usual care [33,34] on agitation and aggressive behavior in older PwD. Physical, aggressive behavior decreased significantly in those who received therapeutic touch. 3.2.4. Staff-focused interventions Two subcategories were identified in this group: training sessions [35–38] and an emotion-oriented care approach [40]. Reviewed trials revealed positive effects of these interventions in residents and health professionals in terms of knowledge, satisfaction, stress, restraint use and general organizational structure. 3.2.4.1. Training sessions, psychosocial management. Four RCTs evaluated separate staff-training programs [35–38]. Differences were found between studies. A training program aimed to increase caregiver motivation and transfer of knowledge into practice [37]. Compared with usual care only, caregivers showed greater caring competencies. Restraint use was also assessed in a 2-arm RCT [35]. There was a significant decrease in the use of restraints postintervention compared to the CG, but this was not maintained over time (6 months). Another staff-training intervention [36] consisting of eight sessions of a combination of didactic and experiential learning was evaluated in comparison with a peer support program facilitating informal support through five peer support sessions and a notreatment group. This study evaluated effects over time. Good selfefficacy results were found on intervention groups although no beneficial effects on staff burnout were observed. 3.2.4.2. Emotion-oriented care interventions. The emotion-oriented care approach seeks to improve emotional and social functioning by supporting PwD when coping with the cognitive, emotional and social consequences of the illness [39]. One RCT assessed emotionoriented care through an intervention intended to improve or maintain emotional balance and positive self-image [40]. Less stress reaction in the EG was reported when compared with the notreatment group. The other RCT was evaluated by family members of PwD. EG participants had a positive opinion of the way nursing staff treated the residents. Emotion-oriented care was more effective in emotional adaptation to nursing homes among people with mild to moderate dementia. There was no added value for those with severe dementia. 3.2.5. Complex interventions These types of interventions consist of many components that act alone and in conjunction. Most are multidisciplinary interventions. Bach et al. (1995) [41] compared the effect of two physical occupational therapy activities. The experimental group received occupational therapy (OT) and functional rehabilitation (FR) while controls received functional rehabilitation alone. Both groups demonstrated positive effects on cognitive performance, psychological functioning and well-being but a comparatively greater improvement was found in the EG. Another study compared an interdisciplinary program with physiotherapy only and a no-treatment group [42]. Both experimental groups showed improvement in functional capacity but no changes were observed in cognition. Bellantonio et al. (2008) [43] conducted a multidisciplinary team intervention in two dementia-specific assisted facilities. Intervention group subjects had lower rates of permanent nursing facility admission, emergency department visits, hospitalization and death than controls. A cluster RCT [44] assessed the effect of person-centered care and dementia-care mapping on reducing agitation. Results showed lower levels of agitation However, while fewer falls were recorded in sites using mapping, more falls were found among those receiving person-centered care. 4. Discussion Non-pharmacological interventions evaluated here focused on improving the QoL of PwD. The most frequent interventions evaluated through RCTs were psychosocial and educational, sensorial and staff-focused interventions. Previous systematic reviews show that psychosocial interventions offer the best available evidence for effectiveness in dementia treatment [45] but our review found little consistent evidence. It appears that although positive outcomes can be identified when managing behavioral disturbances, it is unclear what causes results to be maintained over time. Recent research has identified the need for strong evidence of their effectiveness [46]. Lawrence et al. (2012) showed the benefits of these interventions on QoL and recommend individual psychosocial interventions with a specialist [47]. Behavioral disturbances or neuropsychiatric symptoms (NPS) in residents are a main focus for interventions. Results indicate that these programs can improve QoL and QoC. Negative effects have not been observed but only one structured intervention comparing agitation was found to be statistically significant [15]. Even in reminiscence therapy, a well-established approach [48], we found that there is a need to use a well-designed, structured intervention. The second most frequent interventions were sensorial. Outcomes examine improvements in behavioral disorders. BLT had the best results in agitation management [16–19]. Residents with severe dementia showed the greatest improvement with BLT [28,29]. A systematic review conducted by Ayalon et al. [51] presented similar results. There was a significant reduction in NPS after sensorial therapy although the authors concluded that many of the interventions did not have a solid evidence-base. Mobility can have a positive effect through specific physical activity interventions but this is not due to exercise alone, rather it is the social interaction during the walking activity which is essential to improve compliance enough to produce mobility E. Cabrera et al. / European Geriatric Medicine 6 (2015) 134–150 improvements [24]. This finding is similar to that by Cooper et al. (2012) [49] that no significant QoL differences exist between EG and CG in a kit-based activity. Our findings are subject to several limitations. The PRISMA research terms included ‘‘dementia’’, ‘‘Alzheimer’s disease’’ possibly omitting studies related to non-pharmacological interventions not identified in the study keywords. Our research method did not include trials related to cognitive stimulation programs [50]. It is also questionable whether RCTs are the best evaluation method. There are several difficulties associated with applying blind study design in PwD [20]. All interventions studied called for evaluation of these strategies within further trials to test reproducibility and generalizability. Although most trials support the hypothesis that the intervention would benefit residents, this is concluded discretely. Another relevant factor is the use of robust experimental designs. Most authors reach their conclusions on the basis of very small samples. Studies were also limited by sample heterogeneity, short follow-up periods or insufficiently detailed description of instruments. We found very few reports attempted to blind the assessment of outcomes. Moreover, most interventions had short application periods or follow-up (weeks or a few months). 5. Conclusion We conclude that there is insufficient evidence to determine which non-pharmacological interventions should be included among best practice recommendations. Recommendation based on evidence and consensus is crucial when identifying best practice for PwD. Based on our review, there are non-pharmacological interventions which are effective with respect to managing dementia symptoms and improving QoL and QoC. Nonetheless, we would stress that it should be borne in mind that lack of evidence of efficacy is not evidence of lack of efficacy. Psychoeducational interventions should tailor activities to PwD needs. There is still not enough evidence to support implementation of psychosocial, non-pharmacological interventions in PwD. Disclosure of interest The authors declare that they have no conflicts of interest concerning this article. Acknowledgments We would like to express our gratitude to Montse Navarro, PhD, Carme Alvira, MSc, Marta Farre, MSc, Susana Miguel, MSc, and Ester Risco, MSc, for their participation during the search and data extraction. The RightTimePlaceCare study is supported by a grant from the European Commission within the 7th framework program (project 242153). 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