Effective Cognitive Training based on Surface Computers A multi-national, multicenter, randomized, controlled efficacy study during the SOCIABLE project Stelios Pantelopoulos [email protected] Warsaw 7/10/2011 Cognitive Training as a protection tool Cognitive Training Personalised exercises and activities with various difficulty degrees Focuses on the systematic exercise of specific cognitive functions Aiming to ameliorate or to stablise (at least) the cognitive functions of the patients Project Factsheet •SOCIABLE – “Motivating platform for elderly networking, mental reinforcement and social interaction” •Programme: ICT-PSP - Objective: 1.4: ICT for ageing well with cognitive problems, combining assistive and independent living technologies •Duration: 39 months (May 2009 – July 2012) •Consortium: SingularLogic S.A - Greece CEDAF - Italy University of Valencia - Spain AIJU - Spain -------------------------------------------------------------------------------- Trodheim Kommune - Norway Hygeia S.A. - Greece Municipality of Forlì, Welfare Policies Service - Italy Forli’s Local Sanitary Organization (Geriatric department) - Italy Social Welfare Center – Municipality o Kifissia - Greece Fondazione Santa Lucia - Italy PREVI S.L - Spain Technology Providers Pilot Organisations & Domain Experts What is SOCIABLE • SOCIABLE provides next generation Cognitive Training Services trying to strengthen social activation: A set of Cognitive Training Activities covering all the cognitive skills and are supported by surface computing equipment that are performed in a care center (in group or individual sessions) with the support of a medical expert or a specialised care center employee or at homes of the elderly with (or without) the support of a formal (or informal) carer Supported tools to the Medical Expert in order to design the training programme and to accommodate the cognitive training activities provided to the specific level of deficits of the elderly (personalisation) Monitor the evolution of its patients SOCIABLE users Aged/Elderly (3 Groups) Primary Users Secondary Users Group A: Normal Elderly Group B: Mild Cognitive Impairment Group C: Mild Alzheimer Medical Experts Specialists (e.g., geriatric internists, geriatrics psychiatrists, neurologists, neuropsychologists, nurses, social carers) that are in charge of the aged/elderly users. Medical experts design/configure individualized programmes for the elderly users/ patients they are in charge. Carers Elderly end-users of the SOCIABLE platform Formal or Informal carers that will in charge of the aged/elderly users ICT experts Elderly Groups • Group A: Normal elderly people aged 65+ (patients and/or people attending Municipal Recreation Centers). • Group B: Elderly people aged 65+ with Mild Cognitive Impairment (e.g., according to the Petersen, 2001 criteria - MMSE score 26-30) • Group C: Elderly people aged 65+ with Mild Alzheimers disease (according to the DSM-IV criteria - MMSE score 20-25) SOCIABLE Service places GROUP Session INDIVIDUAL Session Carer SOCIABLE SERVICE Tablet PC INDIVIDUAL Session Surface Computing supported Cognitive Training Sessions SOCIABLE Surface computing equipment Microsoft Surface Table (Care Center) Tablet PC or ALL-IN-ONE PC (Care Center, Homes) Key Features for our experiment Multiuser Multitouch Simplicity Progressive Disclosure Progressive Discovery Integrate Learning with Doing Social interaction and multiuser Games Spatial interaction – 2D & 3D considerations Mixed Reality SOCIABLE Service: A closer look Cognitive Assessment Pre CT or Post CA Activities Leaker Test Cognitive Training Program (Duration 3 months) Cognitive Skills Cognitive Assessment Follow up Assessment 24 Sessions CT Session (60 min) (2 per week) Evaluation of different Cognitive Skills 3 Months CT Session (60 min) (2 per week) Book of Life Session Part 1 Session Part 1 Activity Z Evaluation of different Cognitive Skills Cognitive Skills Cognitive Skills Game X Book of Life Book of Life Individual Cognitive Training Activities (at Homes) Evaluation of different Cognitive Skills Cognitive Skills Session (approx. 45 -60 min) Review the patients records & prepare the session …… … Session Part 1 Session Part 2 Activity 1 Exercis e1 … Performing various cognitive training activities Update the patient file …… … Session (approx. 45 – 60 min) Activity 1 Activity 1 Review the patient(s) files & prepare the session Activity 2 Activity 1 … Performing various cognitive training activities Update the patient(s) files \\p0papalazarou\Shared_Tmp\_TMP SOCIABLE Cognitive Training “Menu” • Memory – – – – – Hide & Find Find the Pairs Do you remember your order Who Belongs Where + MR Remember the Design • Executive Functions – – – – – Analogies Take Away Menu Picture Sort Similarities Differences • Attention – Lost in the City – Guess Who • Language – Synonyms – Antonyms • Orientation – My Home – Travelling in Europe • Logical Reasoning – Incomplete Grids • Constructional Praxis – Puzzle + MR – Copy of Figures Book of Life Activity \\p0papalazarou\Shared_Tmp\_TMP SOCIABLE Cognitive Training “Menu” • Memory – – – – – Hide & Find Find the Pairs Do you remember your order Who Belongs Where + MR Remember the Design • Executive Functions – – – – – Analogies Take Away Menu Picture Sort Similarities Differences • Attention – Lost in the City – Guess Who • Language – Synonyms – Antonyms • Orientation – My Home – Travelling in Europe – • Logical Reasoning – Incomplete Grids • Constructional Praxis – Puzzle + MR – Copy of Figures Book of Life Activity Details about the study Where is SOCIABLE 4 countries - 7 Pilot Sites 350 elderly (274 care centers + 74 homes) Microsoft Surface PREVI Care Center (Valencia) 40 elderly 20+20) Municipality of Trondheim 48 elderly (44 + 4) Municipality of Kifissia 60 elderly (56 + 4) M. Pierantoni Hospital (Forli) 50 elderly (40+10) Fondazione Santa Lucia (Rome) 46 elderly (40+6) Municipality of Forli 44 elderly (30+14) HYGEIA Hospital 60 elderly (44 + 16) Status of the project Pilot Duration - 18 months 3/2010 9/2010 2/2011 Today Initial Version Pilot Start 5/2011 TODAY Clinical Trial 6/2012 7/2012 Project End Medical / Clinical Evaluation THE STUDY PROTOCOL: The SOCIABLE pilot study is a multi-national, multicenter, randomized, controlled efficacy study. Purpose: The main objective of the study is to evaluate the effects of SOCIABLE approach to the cognitive training and social activation of elderly users with diagnosis of MCI, patients with Mild Alzheimer Disease (MAD) and healty elderly subjects. SOCIABLE Program: •Training frequency: two sessions per week, 60 min per session (30 min for cognitive training - 30min for social activation) for twelve weeks (24 sessions) •Training phase: week 1 – week 12 •“Follow-up”: a delayed follow-up examination after 3 months without training to determine whether training effects would be sustained Medical / Clinical Evaluation COGNITION Orientation Abstract reasoning Verbal memory (long term) INFORMED CONSENT Constructional praxis Visuo-spatial memory Verbal memory (short term) •COGNITIVE-AFFECTIVEFUNCTIONAL Executive functions ASSESSMENT Attention • SOCIAL ASSESSMENT Language AFFECTION FUNCTIONAL ABILITIES SEVERITY OF DEMENTIA SOCIAL INTERACTION EXPERTISE IN ICT DIAGNOSIS Mini Mental State Examination Clock Drawing Test IMPACT ASSESSMENT Rey’s Auditory Verbal Learning Test SATISFACTION QUESTIONNAIRE Rey’s Complex Figure (copy) Rey’s Complex Figure (delayed recall) Digit Span Phonological Verbal Fluency Trail Making Test (parts A and B) Naming Test (specific for each country) Geriatric Depression Scale –GDS (short form) ADL, IADL Clinical Dementia Rating LSNS-18; Social Preferences Questionnaire Questionnaire of LEVEL EXPERTISE in ICT (pre-post training) 2 sessions/week =24 sessions T0 T1 T2 Week 1-12 Week 0 “Warm-up” Week 16 “Follow-up” Medical / Clinical Evaluation STUDY POPULATION The sample of the Pilot Operations is represented by: •Group A: normal (cognitively intact) elderly aged 65+ . •Group B: patients aged 65+ with MCI according to the Petersen, 2001 criteria (MMSE score 25-30). •Group C: patients aged 65+ with mild AD according to the NINCDSARDRA criteria (MMSE score 20-24). The SOCIABLE evaluation methodology foresees the involvement of a CONTROL GROUP, which will be compared to the experimental group. Subjects will be randomized to initiate immediately the SOCIABLE treatment or to delay for three months its initiation. The group with delayed treatment will be the “control” for the group of immediate treatment. Study Design: involvement of CONTROL GROUP To this end, the FORMAL OPERATIONS PHASE (lasting 12 months) has been subdivided in 4 quarterly phases (lasting 3 months each), each one involving a quarter of the total number of users envisaged in the site. Therefore the SOCIABLE users will be subdivided in 4 groups: G1, G2, G3, G4 The Control Group will have a 50% size of the total number of SOCIABLE users Medical / Clinical Evaluation In order to evaluate the impact of SOCIABLE program on the different cognitive skills, trained by the games, and the effect on the social interaction and mood of the ederly involved, a complete Assessment Battery will be administered at different stages of the SOCIABLE program: •T0: BEFORE starting the cognitive training •T1: AFTER the cognitive training program •T2: FOLLOW UP assessment after 3 months from the end of the program The Assessment Battery includes: •Neuropsychological Tests •Affective Assessment •Functional Assessment •Social Assessment Medical / Clinical Evaluation COGNITION TESTS and SCALES Orientation Mini Mental State Examination Abstract reasoning Clock Drawing Test Verbal memory (long term) Rey’s Auditory Verbal Learning Test Constructional praxis Rey’s Complex Figure (copy) Visuo-spatial memory Rey’s Complex Figure (delayed recall) Verbal memory (short term) Digit Span Executive functions Phonological Verbal Fluency Attention Trail Making Test (parts A and B) Language Naming Test (specific for each country) AFFECTION Geriatric Depression Scale - GDS (short form) FUNCTIONAL ABILITIES ADL, IADL SEVERITY OF DEMENTIA Clinical Dementia Rating (CDR) SOCIAL INTERACTION LSNS-18 (Lubben and Gironda, 2000) SOCIAL INTERACTION SOCIABLE Social Preferences Questionnaire EXPERTISE IN ICT Questionnaire of LEVEL OF EXPERTISE in ICT (pre-post training) Early Results from the Pilot Operations (first quarter) Allocation of SOCIABLE users Demographic data 90 ** 80 80 70 70 60 60 50 50 Elderly MCI 40 Experimental group 40 30 Control group 30 20 20 10 10 0 Variable t Education df Age MMSE T0 Sig. (2-tailed) Age -1,045 112 0,298 Education -0,853 112 0,396 MMSE T0 -0,473 112 0,637 Variable Group Age Experimental group 57 73,49 6,451 0,854 Control group 57 74,75 6,454 0,855 Experimental group 57 9,04 3,664 0,485 Control group 57 9,67 4,223 0,559 Experimental group 57 27,04 2,958 0,392 Control group 57 27,28 2,569 0,34 MMSE T0 AD 0 Age Education *** N Mean Std. Deviation Std. Error Mean Age Elderly MCI AD Total Education Elderly MCI AD Total MMSE T0 Elderly MCI AD Total Mean Education Std. Deviation N 6,808 5,441 5,567 6,455 Std. Deviation N 9,46 3,697 8,63 4,55 9,82 3,897 9,35 3,949 Std. Deviation N 28,93 1,258 27 2,386 23,57 1,665 27,16 2,761 72,29 76,3 75,89 74,12 Mean Mean MMSE T0 59 27 28 114 59 27 28 114 59 27 28 114 Treatment effects – Global cognition (MMSE) 30 All subjects 29.5 28 MMSE score Experimental Group 28.5 Elderly 28 Control Group 27.5 * 29 29 * T0 T1 28 MCI 27 27 26 T0 T1 25 F(1,112)=5.734, p<.05 T0 T1 25 Assessment Group T0 Experimental 27,04 2,958 Control 27,28 2,569 57 Total 27,16 2,761 114 Experimental 27,63 2,736 57 Control 27,23 2,739 57 Total 27,43 2,733 114 T1 Mean Std. Deviation N 57 24.5 AD 24 23.5 23 T0 T1 *p<.05; **p<.01; ***p<.001 Treatment effects – Memory (Rey’s words immediate) Number of words recalled All subjects 35 Experimental Group * 33 Control Group 31 34 32 30 28 26 24 29 27 T0 43 41 39 37 35 33 31 T1 F(1,112)=10.866, p=.001 *** Elderly T0 MCI T0 Assessment Group T0 Experimental Control Total 30,02 33,93 31,97 16,044 15,967 16,055 57 57 114 Experimental Control Total 34,91 34,91 34,91 19,102 15,977 17,531 57 57 114 T1 Mean Std. Deviation N T1 T1 24 AD 22 20 T0 T1 *p<.05; **p<.01; ***p<.001 Treatment effects – Attention (Trail Making Test) All subjects Seconds 94 90 Experimental Group 86 Control Group 82 130 120 110 100 90 80 70 60 50 78 74 T0 92 88 84 80 76 72 68 64 T1 F(1,109)=2.903, p=.09 * T0 Elderly T1 MCI T0 T1 85 Assessment Group T0 Experimental Std. Deviation N 93,73 48,562 55 91,2 38,422 56 Total 92,45 43,56 111 Experimental 79,13 42,435 55 Control 87,84 36,467 56 Total 83,52 39,599 111 Control T1 Mean AD 75 65 T0 T1 *p<.05; **p<.01; ***p<.001 WP7 – Satisfaction and impact of ICT The psychosocial Impact of Assistive Devices Scale (PIADS) Ability Adaptability Self Esteem -3 3 Satisfaction 10 Users Care givers 21 90 79 Medical experts Patients vs. elderly satisfaction USE it or LOOSE it “Laughs best who laughs last …” “Ages best who Ages last” Our effort is still progressing ... Stay tunned at http://www.sociable-project.eu THANKS FOR YOUR ATTENTION
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