Diabetes Mellitus, Type 2 Clinical Trial
Official title:
The Outcomes of Home-Based Intervention to the Diabetics According to the Health Belief Model: A Randomized Controlled Trial
Why is the research needed?
- This study reflects the complexity of the process that patients with diabetes are
experiencing when staying at home away from the supervision of health professionals. In
this context, there is a gap in the literature on home care of diabetes.
- The barriers, facilitators and the other perceptions that affect each diabetic's
compliance with the disease-related recommendation are different. Nurses need to be
aware of this.
- For this reason, according to the Health Belief Model, an original study was conducted
to evaluate the nursing intervention program's results on patient care and
cost-effectiveness in a home for supporting self-management of diabetic patients.
Hypotheses of the Study Patients with diabetes undergoing home-based nursing interventions in
line with the Health Belief Model.
H1: have higher mean scores for the Health Belief Model Scale than the control group.
H2: have higher mean scores for the Self-Efficacy Scale than the control group. H3: have
lower HbA1c levels than the control group. H4: have lower blood glucose levels (BGL) than the
control group. H5: have lower blood pressure levels than the control group. H6: have lower
BMI levels than the control group. H7: have fewer hospital admissions due to an acute or
chronic complication than the control group.
H8: have a lower complication-related cost rate than the control group.
Type of the study The study was conducted as an intervention (randomized controlled,
single-blind) one.
Location and Time of the Study The study was carried out between January 2015 and March 2017
in three districts of İzmir, a province in the western part of Turkey.
The study population and sample While the patients with diabetes living in districts
comprised the study population, the sample was selected from patients with type II diabetes
registered to Family Health Centers.
According to the Consolidated Standards of Reporting Trials (CONSORT) recommended for
randomized controlled studies, a randomization flow chart was established, and 2460 people
with diabetes were assessed for compliance with diabetes. From the 1081 people with diabetes
who met the inclusion criteria, the intervention, and control groups each to include 65
individuals were constructed using the "Research Randomizer" computer program. The study was
completed with 81 people with diabetes (42 in the intervention group and 39 in the control
group). Post hoc power analysis was performed using the G-Power Data Analysis program and the
power of the study was determined as 100% at the 95% confidence interval and p = .05
significance level.
The participants were not told to which group they were assigned. Thus, the study was
conducted as a single-blind study.
Training Booklet and Implementation Steps A booklet including information on nursing
interventions for diabetes was prepared. The training booklet was based on the current
literature and the results of the qualitative study conducted on the issue in the first step
of the Ph.D. thesis. The booklet was revised in line with the opinions obtained from 5
professors who were experts in the field. The International Standard Book Number
(978-975-441-462-2 ISBN) for the booklet was obtained by the Presidency of Dokuz Eylül
University and published in the Dokuz Eylül University Press.
During the first home visit, the participants in the intervention group were applied the data
collection tools, and then nursing interventions in accordance with the subscales of the
Health Belief Model by taking into account the individual differences of the participants.
The nursing interventions were performed within the scope of the basic dimensions of diabetes
management such as nutrition, exercise, medication management, oral care, and foot care. In
addition, the importance of annual monitoring of HBA1c, blood lipid, albumin/creatinine
levels, fundus examination, blood pressure monitoring, sleep hygiene, avoidance of smoking
and alcohol was also explained. Home visits were paid 3 times at 3-month intervals. After the
home visits started, reminder messages supporting the home visit process were sent at
two-week intervals.
The participants in the control group were contacted 3 times at 3-month intervals through
telephone calls and were applied the data collection tools. At the end of the study, the
participants in the control group were given health training at the Dokuz Eylül University
Faculty of Nursing and the training booklet was distributed to them.
Analysis of the Data The study data were analyzed using numbers, percentages, the chi-square
test, the test for the Significance of the Difference Between Two Means, the Repeated Measures
Multivariate Analysis of Variance, Bonferroni-adjusted t-test independent groups and multiple
regression analysis in the Statistical Package for Social Sciences (SPSS) (23.0) program.
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