Clinical trial NCT04104711: Home-Based Intervention to the Diabetics
Official title: The Outcomes of Home-Based Intervention to the Diabetics According to the Health Belief Model: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes Mellitus, Type 2
Home Visit
Keywords: Diabetes
public health nursing
randomized controlled trials
chronic illness
Health Belief Model
Lead sponsor: Dokuz Eylul University
Sponsor class: OTHER
First posted: 2019-09-26
Enrollment: 81
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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, etc. 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 and booklet was distributed to them.
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* Volunteering to participate in the study
* Having Type 2 diabetes
* Not having diabetes-related complications
* Having a mobile phone to contact any time
* Living in the districts of Balçova, Narlıdere and Güzelbahçe

Exclusion Criteria:

* Having Type I diabetes
* Having been involved in a home care program previously
* Being illiterate in Turkish
* Having disabilities preventing the person from understanding others

Primary outcomes:
measure: Health Belief Model Scale in Patients with Diabetes
timeFrame: 6 month
measure: Diabetes Management Self-Efficacy Scale for Patients with Type 2 Diabetes
timeFrame: 6 month
measure: Fasting plasma glucose level (mg/dl)
timeFrame: 6 month
measure: Postprandial glucose level (mg/dl)
timeFrame: 6 month
measure: Hemoglobin A1c level (%)
timeFrame: 6 month
measure: Body mass index (kg/m2)
timeFrame: 6 month
measure: Blood pressure level (mmHg)
timeFrame: 6 month
measure: Costs via frequency of complication-related hospital admissions
timeFrame: 6 month
Secondary outcomes:
Other outcomes:
measure: Sociodemographic and disease-related characteristics of patients with diabetes
timeFrame: First month
Locations:
Study officials:
affiliation: Manisa Celal Bayar University
name: Dilay AÇIL, Asst.Prof.
role: PRINCIPAL_INVESTIGATOR
affiliation: Koç University
name: Zuhal BAHAR, Prof.
role: STUDY_DIRECTOR
affiliation: Dokuz Eylul University
name: Abdurrahman ÇÖMLEKÇİ, MD,Prof.
role: STUDY_CHAIR
References: