Short-Term Effects of an Educational Program on

Clinical Care/Education/Nutrition/Psychosocial Research
O R I G I N A L
A R T I C L E
Short-Term Effects of an Educational
Program on Health-Seeking Behavior for
Infections in Patients With Type 2 Diabetes
A randomized controlled intervention trial in primary care
LEONIE M.A.J. VENMANS, PHD
KEES J. GORTER, MD, PHD
EELKO HAK, PHD
GUY E.H.M. RUTTEN, MD, PHD
OBJECTIVE — The aim of this study was to assess the short-term effects of an educational
program on (determinants of) self-reported health-seeking behavior for infections of the urinary
tract (UTIs) and lower respiratory tract (LRTIs) in patients with type 2 diabetes.
RESEARCH DESIGN AND METHODS — In a randomized controlled trial, 1,124
patients with type 2 diabetes aged between 44 and 85 years participated. The intervention
consisted of a multifaceted educational program with an interactive meeting, a leaflet, a Web site,
and a consultation with the diabetes care provider. The program focused on the needs of patients,
apparent from a prior focus group and questionnaire study. The primary outcome measure was
an indicator of health-seeking behavior for UTIs and LRTIs, defined as the proportion of participants with a positive score on at least seven of nine determinants, six from the Health Belief
Model and the additional three domains of knowledge, need for information, and intention. The
primary outcome was measured with questionnaires at baseline and after 5 months.
RESULTS — Complete outcome data were available for 468 intervention group patients and
472 control group patients. In all, 68% of the intervention group patients attended the meeting.
At baseline, 28% of the participants from the intervention group had a positive score on seven of
the nine determinants, compared with 27% from the control group. After the educational
program, these percentages were 53 and 32%, respectively (P ⬍ 0.001).
CONCLUSIONS — Our educational program positively influenced determinants of healthseeking behavior for common infections in patients with type 2 diabetes.
Diabetes Care 31:402–407, 2008
D
iabetes and community-acquired
infections are causes of considerable morbidity and mortality. For
example, acute respiratory tract infections
are the most frequent cause of death
among elderly individuals and very
young children and urinary tract infections (UTIs) are an exceedingly common
outpatient problem, especially in women
(1–3). Patients with type 2 diabetes have
an increased risk of UTIs and lower respiratory tract infections (LRTIs) (4 – 8).
Also, common infections in these patients
may be more difficult to treat, often recur
and even require hospitalization, and result in increased mortality (9 –12). There
are few data about the link between
health-seeking behavior and morbidity in
people with diabetes (13,14). We assume
that a delay in health-seeking behavior
will increase the risk of complicated infections. On the basis of this assumption and
on the results of focus group interviews
and questionnaires, we developed, in a
● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ●
From the Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht, Utrecht,
the Netherlands.
Address correspondence and reprint requests to Prof. G.E.H.M. Rutten, Str. HP 6.131, UMC Utrecht,
Julius Center for Health Sciences and Primary Care, P.O. Box 85500, 3508 GA Utrecht, Netherlands. E-mail:
[email protected].
Received for publication 17 April 2007 and accepted in revised form 23 November 2007.
Published ahead of print at http://care.diabetesjournals.org on 4 December 2007. DOI: 10.2337/dc070744. Clinical trial reg. no. ISRCTN10791836, www.ISRCTN.org.
Abbreviations: GP, general practitioner; ITT, intention to treat; LRTI, lower respiratory tract infection;
UTI, urinary tract infection.
© 2008 by the American Diabetes Association.
The costs of publication of this article were defrayed in part by the payment of page charges. This article must therefore be hereby
marked “advertisement” in accordance with 18 U.S.C. Section 1734 solely to indicate this fact.
402
previous collaboration with the Dutch Diabetes Patient Association and Municipal
Health Services, a multifaceted educational program on infections for people
with type 2 diabetes. The most important
part of the program, an educational meeting for patients with type 2 diabetes, was
based on the Health Belief Model. This
model includes six domains—perceived
susceptibility and severity, perceived barriers and benefits, social support (cues to
action), and self-efficacy—and has
proven to be valid for evaluating health
behavior (15). The aim of this study was
to assess the short-term effects of an educational program on (determinants of)
self-reported health-seeking behavior for
UTIs and LRTIs in patients with type 2
diabetes. We primarily hypothesized that
the program would positively affect determinants of health-seeking behavior in
cases of UTIs and LRTIs in type 2 diabetic
patients (hypothesis 1). Further, we hypothesized that such an intervention
could improve actual health-seeking behavior in such cases (hypothesis 2). We
further explored potential differences in
effects among the group of patients at
high risk for complications and among
patients with a lower educational level.
RESEARCH DESIGN AND
METHODS — We recruited 101 general practitioners (GPs) in four regional
Municipal Health Services: one in the
north, one in the east, and two in the
south of the Netherlands, covering 2.7
million people in total. All patients with
type 2 diabetes between the ages of 44 and
85 were eligible for inclusion in this
study; participating GPs sent a recruitment letter to 30 randomly selected eligible patients from their practices. Patients
not able to attend a meeting because of
immobility, and individuals with insufficient knowledge of the Dutch language
were excluded.
Development of the intervention
In a previous collaboration with the
Dutch Diabetes Patient Association and
DIABETES CARE, VOLUME 31, NUMBER 3, MARCH 2008
Venmans and Associates
the Municipal Health Services, we developed an educational program targeted to type 2 diabetic patients. The
unpublished methods and data guiding
the development of this intervention are
included in online appendix 1 (available at http://www.juliuscenter.nl/
appendix_venmans_et_al.pdf). The
final program consisted of an invitational letter for a meeting (which contained questions as a first “cue” for
patients to think about infections), an
interactive meeting, a patient information leaflet, a consultation with the diabetes care provider, a Web site, and a
newsletter. For the design of the meeting, the domains of the Health Belief
Model (15) were used and the domains
of knowledge, need for information,
and intention were three supplementary domains studied. We addressed a
total of nine determinants of healthseeking behavior. Patients who were not
able to attend a meeting received written information at their home address
with the same content as that discussed
during the meetings. Intervention tools
and recruitment letters are given in online appendix 2.
Randomization
Practices were randomly assigned to an
intervention or a control group. Both care
providers and their enlisted patients with
type 2 diabetes were randomly assigned
to the same group. We used block randomization, taking into account the region where the practice was located and
the size of the practice (single-handed
versus group practice). The control group
did not receive any intervention.
Implementation of the intervention
Before the implementation of the intervention, all patient educators received
standardized training, and the patient information leaflet and material content of
the educational meeting were carefully pilot tested in small samples of patients
from the target group before the main intervention. The intervention was implemented in October 2005 with the
invitation to participate in the 2-h educational meeting. Partners were also invited
to attend. A total of 22 local meetings
were held throughout the health regions
(six in three regions and four in the remaining region), and all meetings were
held within 3 weeks of each other. The
average participation rate was 68%. In the
Netherlands, type 2 diabetic patients visit
DIABETES CARE, VOLUME 31, NUMBER 3, MARCH 2008
their diabetes care provider four times a
year for a regular check-up. As part of the
intervention, employees of the Municipal
Health Services visited the diabetes care
providers and asked them to discuss
symptoms and risks of infections during
these check-ups. The Web site (http://
www.juliuscenter.nl/diabetes/infecties
[in Dutch]) was online from October
2005 to March 2006. The educational
newsletter was sent 3 months after the
start of the intervention.
Measurements: questionnaires and
diaries
Questionnaires (health behavioral determinants). Evaluation questionnaires
were developed on the basis of results of
focus groups conducted during the development of the intervention (online appendix 1) and with guidance from the
field of vaccination behavior (16,17).
Baseline measurements (T0) were assessed in September 2005 and effects (T5)
in March 2006 by means of written questionnaires. The requested time for responding was 1 week, and both mailed
(up to two) and telephone reminders
were used. The first part of the questionnaire consisted of patient characteristics
such as age, sex, educational level, type of
diabetes treatment, and comorbidity. The
remaining components of the questionnaire assessed determinants of healthseeking behavior (online appendix 3). We
pretested the questionnaire in a few patients and assessed readability and comprehension. Answering categories were
either dichotomous or according to
5-point Likert scales.
Diaries (self-reported health behavior).
Participants were asked to keep a diary for
20 weeks (from October 2005 to March
2006). The diaries were sent to the homes
of the participants after the meeting with
instructions on how to complete them.
We did not send the diaries before the
intervention because we did not want to
raise awareness among the control subjects. The requested time to respond was
1 week after the conclusion of the 20week study period. Two written reminders were used. In the diary, symptoms of
LRTI and UTI and visits to GPs were reported. The severity of the symptoms was
assessed on a 4-point scale from “no discomfort” to “great discomfort.”
Outcome measurements. The primary
outcome measure was an indicator of
health-seeking behavior for UTIs and
LRTIs, defined as the proportion of par-
ticipants with a positive score on statements pertaining to the nine abovementioned determinants of healthseeking behavior. A positive score per
person was assigned if results for at least
seven of the nine determinants of healthseeking behavior were positive. Per determinant, one or more statements were
posed. At least half of the statements per
determinant had to be positive. The secondary outcome measures were changes
in the nine separate behavioral determinants of health-seeking behavior. With
regard to our second hypothesis, outcome
measures were the percentages of cases in
which there was self-reported contact
with the primary care practice. For LRTI,
these cases were coughing and shortness
of breath and coughing and fever for
longer than 2 days. For UTI, these cases
were complaints of the urinary tract for
longer than 2 days or complaints of the
urinary tract and fever for longer than 1
day (females) and just complaints of the
urinary tract (males). . These criteria were
derived from the advice given during the
educational meetings. They were measured by means of the diaries.
Statistical analysis
Data were analyzed using SPSS software
for Windows (version 12.0; SPSS, Chicago, IL). Statements that were measured
on 5-point Likert scales were dichotomized in the two most positive answers
versus the other three responses. Proportions and means were used to describe
baseline characteristics.
Changes in determinants of behavior
between T0 and T5 were measured with
ANCOVA. This method was used because
it adjusts each patient’s follow-up score
for his or her baseline score and has the
advantage of being unaffected by baseline
differences (18). ANCOVA was applied
using the generalized equation estimation
model to adjust for differences in baseline
and for clustering at the level of practice
(19). This step was performed using SAS
Proc Genmod (version 8.02; SAS, Cary,
NC). Odds ratios (ORs) and 95% CIs are
presented for questionnaires only for
those determinants with P ⬍ 0.05. Analyses were done according to the intention-to-treat (ITT) principle. In addition,
we planned an on-treatment analysis
comparing the scores in patients who actually visited the meetings with those of
patients who did not and control patients.
Subgroup analysis was done for patients
with a lower educational level and for pa403
Effects of education on infections in diabetes
Figure 1—Flow of patients through trial.
tients at high risk for a complicated course
of infections. ␹2 analyses were used to analyze the diaries. Subgroup analysis was
done for instances in which the patient
reported severe complaints only (great
discomfort).
RESULTS — Of the 1,124 patients
who were randomly assigned and responded to the baseline questionnaire,
572 were assigned to the intervention
group and 552 to the control group (Fig.
1). Baseline characteristics are given in
Table 1. The mean ⫾ SD age was 64 ⫾ 9
years, 53% of the participants were male,
404
comorbidity was present in 44% of the patients, and insulin was used by 13% of the
patients. Mean duration of diabetes was 6 ⫾
7 years. Complete outcome data were
available for 468 and 472 patients in the
intervention and control groups, respectively. Compared with control subjects,
participants in the intervention group who
were lost to follow-up were more often men
than women (55 vs. 42%). Of the patients
who were lost to follow-up, the duration of
diabetes, the use of insulin, age, and the
intention to consult the GP when symptoms
of infections were present did not differ between groups.
Compliance with the intervention
The meeting was attended by 68% of the
intervention group patients for whom
complete data were available (compared
with 46% of all patients for whom data
were incomplete). In total, 25% of the patients indicated that their risk of infection
had been discussed with their diabetes
care provider, 44% had read the newsletter, and 9% of the patients who had Internet access had visited the Web site.
Health behavioral determinants
ITT analysis. Hypothesis 1. Compared
with control subjects, knowledge of the
DIABETES CARE, VOLUME 31, NUMBER 3, MARCH 2008
Venmans and Associates
Table 1—Baseline characteristics
Characteristics
n
Demographic variables
Male sex
Age (years)
Born in the Netherlands
High educational level*
Living single
Smoking
Diabetes-related variables
Duration of diabetes (years)
Treatment†
Insulin
Oral diabetes medication
Blood glucose well regulated‡
Comorbidity§
Cardiovascular disease
Chronic obstructive pulmonary disease
Other lung disease (e.g., asthma)
Cerebrovascular disease
Urinary incontinence
Renal disease (urolithiasis included)
Intervention group
Control group
572
552
54.2
64.3 ⫾ 8.7
97.5
20.5
16.6
14.7
52.7
64.0 ⫾ 8.7
96.7
18.7
18.5
17.4
6.6 ⫾ 7.2
6.1 ⫾ 6.3
15.2
82.2
88.8
10.8
82.9
89.9
19.1
7.5
4.6
3.3
7.8
1.3
19.7
7.0
5.9
3.0
6.0
2.3
Data are % or means ⫾ SD. *High educational level: senior general secondary, preuniversity, and technical
and vocational for those aged ⱖ18 years and university. †More answers possible. ‡Measured on 5-point scale
(always to never). The two most positive answers are shown. §Dichotomized measure (yes/no).
risks of UTI and LRTI in intervention
group subjects increased (31 vs. 4% for
UTI and 37 vs. 0% for LRTI). The same
was true for knowledge of the symptoms
of UTI and LRTI (11 vs. 0% and 31 vs.
4%, respectively). Moreover, bronchitis
and cystitis were perceived by more patients as dangerous (21 vs. 5% and 22 vs.
4%, respectively). Confidence to contact
the GP if the practice was difficult to reach
increased among participants in the intervention group, whereas among the control group this percentage remained at the
baseline level (6 vs. 1% in control subjects). Furthermore, the intention of intervention group patients to consult the
GP increased when they had symptoms of
a UTI (3 vs. ⫺3% in control subjects) and
LRTI (4 vs. ⫺5%) (Table 2). Although the
baseline figures were already very positive, the intention to seek medical attention because of symptoms that could
indicate an infection increased. Compared with the control subjects, the intervention group patients did not change
their belief about a decreased risk of seri-
Table 2—Determinants of health-seeking behavior in cases of diabetes and infections: changes after 5 months*†
Intervention
group
N
n
Knowledge
Not always fever in UTI
Increased risk complicated UTI
Increased risk UTI
Coughing/fever in LRTI
Increased risk LRTI
Adjust diabetes medication
Perceived severity
Bronchitis is dangerous
Cystitis is dangerous
Perceived susceptibility
Increased risk infections
Increased risk complications
Social support
Support from partner
Self-efficacy
Confident if practice difficult to reach
Need for information
Knowledge of symptoms
Intention
Seeking medical attention UTI
Seeking medical attention LRTI
T0
(%)
T5
(%)
Control group
T0
(%)
T5
(%)
⌬1
(%)*
468
⌬2
(%)*
Adjusted OR
(95% CI)†
P
value
472
904
902
911
897
908
794
12.8
17.1
31.9
34.4
19.8
33.7
24.2
32.2
62.6
65.0
56.7
41.5
14.0
12.6
27.6
35.0
22.3
35.4
14.2
17.3
31.8
39.2
22.7
33.1
11.4
15.1
30.7
30.6
36.9
7.8
0.2
4.7
4.2
4.2
0.4
⫺2.3
2.2 (1.6–3.1)
2.2 (1.8–2.8)
4.2 (2.9–6.1)
3.5 (2.5–4.7)
5.4 (3.7–7.8)
1.5 (1.1–2.3)
⬍0.001
⬍0.001
⬍0.001
⬍0.001
⬍0.001
0.009
866
873
32.0
25.0
53.4
47.0
30.5
21.2
35.2
24.9
21.4
22.0
4.7
3.7
2.3 (1.7–3.1)
3.2 (2.4–4.2)
⬍0.001
⬍0.001
911
907
58.3
37.8
76.0
47.5
49.0
36.5
56.3
36.1
17.7
9.7
7.3
⫺0.4
2.4 (1.8–3.2)
1.5 (1.1–1.9)
⬍0.001
0.005
646
93.3
95.9
94.9
91.8
2.6
⫺3.1
2.7 (1.3–5.4)
0.007
672
30.2
35.8
25.1
26.3
5.6
1.2
1.5 (1.1–2.1)
0.024
888
60.4
77.6
57.6
60.5
17.2
2.9
2.5 (1.7–3.6)
⬍0.001
914
908
89.5
71.6
92.2
75.3
91.2
74.9
88.4
70.1
2.7
3.7
⫺2.8
⫺4.8
1.8 (1.2–2.7)
1.5 (1.0–2,0)
0.004
0.032
Only abbreviations of questions are given. For complete questions, see http://www. juliuscenter.nl/appendix_venmans_et_al.pdf. Outcomes with P ⬍ 0.05 are
presented. *⌬1 ⫽ difference between intervention group T0 and T5; ⌬2 ⫽ difference between control group T0 and T5. †ORs after application of the generalized
equation estimation model.
DIABETES CARE, VOLUME 31, NUMBER 3, MARCH 2008
405
Effects of education on infections in diabetes
ous consequences if they contacted the
GP (0 vs. ⫺4%).
Hypothesis 2. At baseline, 28% of the
intervention group participants had a
positive score on seven of the nine determinants compared with 27% of the control subjects. After the educational
program, these percentages were 53 and
32%, respectively, indicating an improvement of 25% in the intervention group
compared with 5% in the control subjects
(P ⬍ 0.001). Analyses done separately for
patients with lower educational levels
(from 24 to 50% in intervention patients
and from 25 to 27% in control subjects) as
well as for patients at high risk for a complicated course of infections (from 40 to
57% and from 31 to 43%, respectively)
showed no substantial differences with
the overall results.
A sensitivity analysis showed that the
proportion of participants with a positive
score on at least six of nine determinants
increased from 50 to 72% (46 to 53% in
control subjects; P ⬍ 0.001). For at least
eight of nine determinants, the proportion of participants increased from 11 to
36% (11 to 13% in control subjects; P ⬍
0.001).
On-treatment analysis. Hypothesis 1.
Subgroup analyses for participants of the
intervention group who attended the
meeting showed a 45% difference in
knowledge about risks of LRTI (0% in
control subjects). Knowledge about risks
of UTI increased in 33% (5% in control
subjects); knowledge of symptoms of UTI
and LRTI increased in 15% (0% of control subjects) and 35% (4% of control
subjects), respectively; and confidence
to contact the GP if the practice is difficult to reach increased in 9% (1% in
control subjects).
Hypothesis 2. After the educational
program, 58% of the intervention group
participants scored positively on seven of
the nine determinants (ITT 53%). Of the
intervention group participants who did
not attend the meeting, 42% had a positive score.
Self-reported health behavior. Hypothesis 2. In total, 69% of the patients returned the diary, equally divided over the
two groups. Of the patients in the intervention group, 43% (23 of 54 patients
with symptoms) sought care for symptoms of UTIs, compared with 32% (21 of
65) of the control subjects. For LRTIs, the
figures were 49% (51 of 105) and 41%
(43 of 106), respectively. There was a
trend toward visiting the GP more often.
The differences were most obvious for
406
men with complaints of the urinary tract
(57 vs. 35%; OR 2.2 [95% CI 0.8 – 6.4]).
Subgroup analyses for serious complaints
(great discomfort) revealed an even larger
difference for LRTIs (49 vs. 32%; 2.2
[0.8 – 6.6]); however, the numbers were
small.
CONCLUSIONS — This is, to our
knowledge, the first study that has assessed the short-term effects of an educational program on health-seeking
behavior for infections in type 2 diabetic
patients. Patient characteristics were
comparable with those of typical Dutch
type 2 diabetic patients (20,21). The
program positively influenced determinants of health-seeking behavior. The
proportion of participants with a positive score on at least seven of nine determinants of health-seeking behavior
almost doubled from 28 to 53% (compared with an increase from 27 to 32%
in control subjects).
The program especially increased the
knowledge for the type 2 diabetic patients
about the symptoms and risk factors of
infections. It enhanced a realistic risk perception. In addition, self-efficacy and the
intention to seek medical attention were
positively influenced. On some points the
effects of the education were limited; e.g.,
patients did not believe they had a decreased risk of serious consequences
when seeking medical attention because
of symptoms indicating an infection. An
explanation might be the so-called “ceiling effects,” as the baseline data were already positive. The differences found
between the on-treatment and ITT analysis supported the fact that the meetings
were an essential part of the educational
program in light of the fact that the proportion of patients who had read the
newsletter (44%) or visited the Web site
(9%) was relatively low. Unfortunately,
we cannot compare these findings with
those of other studies because the designs
of most studies do not allow disentangling
of the effects of the different components
(22).
It is known that many men with
complaints of the urinary tract do not
visit their GP (23). We found a trend of
intervention group patients visiting the
GP more often, especially men with
complaints of UTIs. However, the differences between the intervention and
the control groups were not statistically
significant. This result may be due to
low numbers, because subgroup analysis for serious complaints of LRTIs re-
vealed larger differences and may
indicate that patients with type 2 diabetes perceive the necessity of seeking
medical attention even more when complaints of LRTIs are serious.
The results of our study should be
considered cautiously. Effects regarding
intention to seek medical care were positive but moderate. However, the fact that
all determinants changed positively may
indicate that health-seeking behavior for
infections by this high-risk group of patients will improve. We believe that this
program is a first step in changing the perception of type 2 diabetic patients. Small
changes may have a considerable effect on
a larger scale.
Our study has several limitations. The
first is the short duration of the follow-up.
Positive effects from educational programs are mostly shown for interventions
of a shorter duration. Indeed, one study
showed that 1 year after the last session of
an educational program, most of the clinical effects are lost (24). Also, our study
showed a suboptimal use of the tools developed (newsletter and Web site). Barriers as to why patients did not fully use the
tools provided with the program were not
identified systematically. Further research should be conducted to assess
ways of improving the use of the tools
provided and facilitate their implementation in daily practice. A third limitation is
the insufficient number of observations of
serious complications to permit subgroup
analysis. However, we believe that such a
relation can be assumed for infections in
diabetes care. Delays in care seeking lead
to delays in treatment and may in turn
lead to serious complications. A fourth
limitation is that all measures were selfreported. We could have used medical
records to validate health-seeking behavior. Whether the reported behavior is
more likely to be overreported because of
social desirability or underreported because of recall bias remains unclear. A
fifth limitation is the kind of “dummy”
intervention that might address concerns
about the Hawthorne effect. Indeed,
among all control subjects we raised
awareness by asking about their behavior.
For that reason differences between
groups could have been diminished.
Therefore, the Hawthorne effect, if any,
would have biased our results to accepting the null hypothesis (finding no difference between groups).
This study clearly demonstrated a
benefit in health-seeking behavior for
type 2 diabetic patients. Results from this
DIABETES CARE, VOLUME 31, NUMBER 3, MARCH 2008
Venmans and Associates
study suggest that patients and practitioners should discuss infections during regular check-ups. Materials (such as
leaflets) could be used to increase the implementation of the program in daily
practice. Diabetes care providers could
instruct people with type 2 diabetes to
contact the medical practice when symptoms occur. Just this little effort on the
part of diabetes care providers could result in large effects on the burden of common infections in people with type 2
diabetes.
Acknowledgments — This work was supported by the Public Health Fund (U03/175P230) and the Dutch Diabetes Research
Foundation, the Netherlands (2003.00.031).
We thank the general practitioners and diabetic patients who participated in this study
and acknowledge M. Smit for her administrative assistance and J. Box for language review.
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