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A Randomized Trial Comparing Intensive and Passive Education in Patients With Diabetes Mellitus
Annaswamy Raji, MD;
Helen Gomes, MSN;
Judith O. Beard, BS;
Patricia MacDonald, RD;
Paul R. Conlin, MD
Arch Intern Med. 2002;162:1301-1304.
ABSTRACT
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Background Patient education is a cornerstone of treatment in diabetes mellitus,
but there is not unanimity of opinion as to how it should be delivered.
Objective To determine whether a single, intensive group educational program would
improve glycosylated hemoglobin (HbA1c) levels when compared with
passive education.
Methods A total of 106 patients with HbA1c levels greater than 8.5%
were randomized to either an intensive (n = 50) or a passive education (n
= 56) group. The intensive education group received 3.5 days of a structured
curriculum involving a physician, nurse, nutritionist, pharmacist, exercise
physiologist, and a social worker. The passive education group received material
sent by mail every 3 months providing basic information on topics related
to diabetes management. Patients continued care with their diabetes care provider
during the study period. Levels of HbA1c were measured at baseline
and 3, 6, and 12 months after randomization. A matched control group of individuals
who declined participation also had HbA1c levels measured at baseline
and 12 months.
Results Mean ± SD HbA1c levels fell significantly (P<.001) from baseline (9.9% ± 1.3%) in both the intensive
(-2.0%) and passive (-1.9%) education groups at 12 months, and
there was no difference between the groups at any evaluation time. Both groups
had significantly greater decline (P<.03) in HbA1c levels than a matched control group (-1.2%) with similar baseline
HbA1c levels that did not receive education.
Conclusions Patients with elevated HbA1c levels who were receptive to
education had substantial improvement in HbA1c levels after receiving
an educational intervention. In this population, intensive or passive methods
of delivering patient education seemed to have similar effect on improving
glycemic control.
INTRODUCTION
DIABETES MELLITUS (DM) is a chronic disease that requires ongoing care
tailored to the needs of the patient. Patient education is considered a cornerstone
of treatment in DM. Education alone may not be sufficient to improve patient
outcomes, but it forms the framework on which medications, nutrition, and
other lifestyle modifications are built. Approximately 50% to 80% of people
diagnosed as having diabetes lack significant knowledge and skills to manage
the condition effectively.1 One of the goals
of Healthy People 20102
is to increase to 60% the proportion of individuals with diabetes who receive
formal diabetes education. While there is no unanimity of opinion as to how
we should deliver education, there is consensus on the necessary content for
an educational program.3
Traditionally, diabetes education has been aimed at increasing patient
adherence with physician-defined therapeutic goals and treatment strategies.
One reason this approach may not consistently result in good outcomes is lack
of participation by individuals in their own treatment. Active participation
by patients demands motivation, knowledge, and adherence to an often difficult
and complex lifetime regimen.
The present study compared the effectiveness of a single intensive group
educational program (designed to improve knowledge and encourage active participation
by patients in their diabetes management) with a passive education program.
Our goal was to gain insight into the relationship between the type of educational
intervention and its effect on glycemic control.
PATIENTS AND METHODS
The study was conducted at the Veterans Affairs Boston Healthcare System,
Boston, Mass, and was reviewed and approved by the institutional review board.
Informed written consent was obtained from each participant prior to entry
into the study. Hospital laboratory data were screened on a monthly basis
for potential study participants by identifying individuals with an elevated
glycosylated hemoglobin (HbA1c) level (>8.5%). A total of 912 individuals
were identified over a 6-month recruitment period and were sent a letter describing
the study and soliciting their participation. Follow-up telephone calls were
placed to all of these potential participants at least 2 weeks after sending
the recruitment letter. Telephone contact was made with 380 individuals: 211
declined participation; 63 were ineligible; and 106 participated (Figure 1).
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Figure 1. Chart of patient recruitment and
randomization.
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Patients were deemed eligible if they met the following criteria: HbA1c level greater than 8.5% (measured within 30 days of randomization);
age 18 years or older; able to exercise; available to participate (if randomized
to the intensive education program); and able to understand written and spoken
English. Participants were excluded if they had significant eye disease limiting
visual acuity; urine protein level greater than 2 g/d; coronary artery disease
symptoms; and/or lower extremity amputation that limited exercise capacity.
We compared 2 educational programs: an intensive education group and a passive
education group.
INTENSIVE EDUCATION GROUP
Participants randomized to the intensive group received 3.5 days of
a structured curriculum through lectures, group discussions, and supervised
exercise. The sessions were conducted in groups of 4 to 6 participants and
contained all the core elements recommended by the American Diabetes Association
for diabetes education curricula.3 Participants
had an initial evaluation performed by a certified diabetes educator to determine
their current knowledge base and individual needs and goals. Two meals and
snacks were provided on each day of their participation as a means of reinforcing
the nutritional instruction. Professionals actively involved in the program
included a physician, nurse, nutritionist, pharmacist, exercise physiologist,
and a social worker. A certified diabetes educator was charged with overseeing
each participant throughout the course of the educational program. After completing
the intensive educational program, participants were returned to their usual
care. Of the 50 individuals randomized to receive intensive education, all
but 1 participated in and completed the program. Data from the individual
who did not participate were included in the analyses.
PASSIVE EDUCATION GROUP
Participants in the passive group received educational materials mailed
to their home every 3 months. The educational materials included booklets
(15-45 pages) containing the following themes: general diabetes management,
nutrition, coronary artery disease, and foot care. All patients received their
usual medical care in addition to the educational materials. Fifty-six individuals
were randomized to receive passive education. Participants in both groups
were asked to return 3, 6, and 12 months after randomization for measurement
of HbA1c levels.
CONTROL GROUP
From the group of 211 individuals with HbA1c levels greater
than 8.5% who were contacted but declined participation, we identified individuals
who had HbA1c levels measured again at a mean ± SD follow-up
of 12 ± 3 months from an initial screening level. We matched 56 persons
by age, sex, and baseline HbA1c level to those in the passive education
group.
HbA1c ASSAY
Glycosylated hemoglobin levels were measured in the hospital laboratory.
High-performance liquid chromatography was used to separate the hemoglobin
components and to measure the 6 fractions of hemoglobin, including the HbA1c component.
STATISTICAL ANALYSES
Data are expressed as means ± SDs unless indicated otherwise.
All analyses compared subjects according to their status at randomization
and were conducted in an "intent-to-treat" manner, with the last value carried
forward for missing data. Variables not normally distributed underwent appropriate
transformation. Comparisons within groups were performed using analysis of
variance with repeated measures. Comparison among groups was performed by
2-way analysis of variance, using Bonferroni correction when appropriate.
A 2-tailed probability level lower than .05 was considered statistically significant.
RESULTS
The baseline characteristics of the 106 randomized participants are
as follows: The mean age was 60 ± 3 years; 99% were men; and mean body
mass index (calculated as weight in kilograms divided by height in meters
squared) was 32 ± 1. The mean HbA1c level was 9.9% ±
1.3%. A total of 46% of the patients were being treated with oral hypoglycemic
agents (31% with a single agent; 15% with 2 agents in combination), 39% with
insulin, and 15% with combination insulin and oral agents.
There was a significant decrease in HbA1c levels compared
with baseline in both groups (P<.001) at all serial
points of measurement (Figure 2).
There was no difference in HbA1c levels between groups at any measurement
time. At 1 year, the decline from baseline was 2.0% in the intensive education
group and 1.9% in the passive education group.
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Figure 2. Glycosylated hemoblobin (HbA1c) levels in intensive and passive education groups at baseline and
3, 6, and 12 months after randomization. Asterisks indicate P<.001
for decrease.
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During the course of the study we tracked medication changes in randomized
participants. At the end of 12 months, participants in the intensive education
group were more likely to be undergoing oral combination therapy (more than
1 oral agent) and less likely to be undergoing monotherapy with an oral agent
(Figure 3) than participants in
the passive group. The percentage of patients receiving combination therapy
of insulin with an oral agent was similar to the percentage receiving insulin
alone.
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Figure 3. Medication use at the end of the
study in both intervention groups.
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To address the question of whether the similar decrease in HbA1c in both groups was an effect of intervention, a result of regression
to the mean, or a result of ongoing care, we pooled the intervention groups
and compared them with a matched control group of individuals who declined
participation in the study. There was no significant difference between the
baseline HbA1c levels of the intervention and control groups: 9.9%
± 1.3% and 9.8% ± 1.2%, respectively. At 12 months, these levels
had decreased to 8.0% ± 1.4% and 8.6% ± 1.8%, respectively.
There was a significantly greater decline in HbA1c level in the
combined intervention groups than in the control group (P<.03).
COMMENT
Our study demonstrates that an educational intervention in patients
with diabetes mellitus has a significant effect on HbA1c level,
but the manner in which it is delivered is not important. The decrease in
HbA1c level of approximately 2.0% after 1 year in both intervention
groups is significant and similar to that obtained in the Diabetes Control
and Complications Trial,4 which also showed
that a 2% decrease in HbA1c level reduces the risk of future complications
by 70%. Maintaining this mean decrease in HbA1c level would represent
a significantly reduced lifetime risk for microalbuminuria, retinopathy, and
neuropathy.5
We were surprised to find that there was no significant difference in
the metabolic control achieved in the single intensive education and the passive
education treatment groups. It is likely that the participants who enrolled
in the study were highly motivated and, regardless of group assignment, prepared
to make a change in their diabetes control. For this reason we compared both
groups with individuals drawn from the same pool of patients who declined
participation. These individuals also had a decline in HbA1c level,
but it was significantly less than that of the intervention groups. Thus,
the modest intervention given to the passive education group was sufficient
to achieve a significant reduction in HbA1c level.
There is evidence to suggest that changes in attitude and motivation
are needed to achieve metabolic control in patients with diabetes, and integrating
educational interventions with intensive insulin treatment is important in
achieving metabolic control.6-7
Contrary to this evidence, the present randomized controlled study showed
that passive education integrated with ongoing care achieved glycemic control
similar to that achieved by intensive education. Our results suggest that
offering diabetes education to patients who are interested in receiving it
may be cost-effective and cost beneficial, based on improvement in glycemic
control.8-12
This decrease in HbA1c level with the added benefit of corresponding
reduction of lifetime risk for developing chronic complications could also
result in improvement in quality of life for individuals with diabetes.
The overall effect of education on glycemic control in patients with
diabetes is mixed.13-18
Length of follow-up after the educational intervention may affect the findings
of a study—studies with less than 6 months follow-up tend to demonstrate
greater effectiveness than studies with longer follow-up.13-15,19-20
Few studies with longer follow-up have shown significant effects on glycemic
control. Two studies21-22 demonstrated
improved glycemic control and 10 others showed no significant effects despite
regular patient contact.6, 9, 23-30
In some studies the method of education delivery affected the improvement
in glycemic control. Compared with didactic interventions, collaborative interventions
produced favorable results, particularly if the interventions were repetitive
and ongoing.15, 20, 27, 31
Indeed, part of the effectiveness of the passive education offered to our
patients may have come from the repetitive nature of the mailings that patients
received. Nonetheless, our study suggests that patient education in diabetes
need not require face-to-face contact to have significant effects, particularly
when targeted to a motivated group of patients.
Our results reinforce the need for and benefits of incorporating educational
interventions into the management of patients with diabetes. Furthermore,
passive educational methods had a similar effect on HbA1c levels
when compared with intensive education. This suggests that any educational
method that provides instruction in the core content areas, particularly when
delivered to patients who are interested and receiving ongoing care, can be
an effective means for reducing HbA1c levels.
AUTHOR INFORMATION
Accepted for publication October 9, 2001.
This study was supported by a grant from the Department of Defense,
Washington, DC.
Results were presented at the American Diabetes Association 61st Scientific
Annual Meeting, Philadelphia, Pa, June 25, 2001.
Corresponding author and reprints: Annaswamy Raji, MD, Endocrinology-Hypertension
Division, Brigham and Women's Hospital, 221 Longwood Ave, Boston, MA 02115
(e-mail: araji{at}partners.org).
From the Endocrine Section, Veterans Affairs Boston Healthcare System
(Drs Raji and Conlin), and the Endocrinology-Hypertension Division, Brigham
and Women's Hospital, Harvard Medical School (Drs Raji and Conlin and Mss
Gomes, Beard, and MacDonald), Boston, Mass.
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