Home-Based Intervention to the Diabetics

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04104711
• Other study ID #: 970-GOA, 2014 / 07-20
• Status: Completed
• Phase: N/A
• Start date: January 1, 2015
• Est. completion date: July 14, 2017

Study information

• Verified date: September 2019
• Source: Dokuz Eylul University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 81
• Est. completion date: July 14, 2017
• Est. primary completion date: March 30, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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, Narlidere 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

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2
• Home Visit

Intervention

Other:
• Home visits, health education

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Dilay AÇIL,PhD

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Sociodemographic and disease-related characteristics of patients with diabetes	This form includes questions about the sociodemographic and disease-related characteristics of patients with diabetes (age, sex, educational status, diagnose period, type of antidiabetic treatment, forgetfulness, glucose home monitoring, etc.).	First month
Primary	Health Belief Model Scale in Patients with Diabetes	The Health Belief Model Scale was developed in China, the validity and reliability study of the Turkish version of the scale was conducted in 2007 and the Cronbach's alpha value was 0.72 and 0.90 respectively. The subscales of the scale were as follows: perceived Susceptibility (5 items), Perceived Severity (3 items), Perceived Benefits (7 items), Perceived Barriers (11 items) and Recommended health-related activities (10 items).; The items of the scale are evaluated in a 5-point Likert scale, from 1 (I strongly disagree) to 5 (I strongly agree). Every subscale mean isdetermined by dividing the total points of all thesubscale items by the total number of items. The total scale score mean is calculated by dividing the totalpoints of all the items by the total number of items. A positive health belief of 4 points and above; a score below 4 is interpreted as a negative health belief.	6 month
Primary	Diabetes Management Self-Efficacy Scale for Patients with Type 2 Diabetes	Diabetes Management Self-Efficacy Scale was developed in 1999, the validity and reliability study of the Turkish version of the scale was conducted in 2001. The Cronbach's alpha value was 0.89 for both versions .The scale has 4 subscales: nutrition specific and weight, physical exercise, and blood sugar, nutrition general and medical treatment. The tool has 20 items. The items are in a 5-point Likert scale from 1 (absolutely no) to 5 (absolutely yes).The lowest possible score from the scale is 20, the highest is 100.	6 month
Primary	Fasting plasma glucose level (mg/dl)	The mean of plasma glucose level (milligram / deciliter) was used to compare patients' diabetic control and evaluate pre- and post-intervention values in the study process.	6 month
Primary	Postprandial glucose level (mg/dl)	The mean of postprandial glucose level (milligram / deciliter) was used to compare patients' diabetic control and evaluate pre- and post-intervention values in the study process.	6 month
Primary	Hemoglobin A1c level (%)	The mean of Hemoglobin A1c level (per cent) was used to compare patients' diabetic control by 3 months period and evaluate pre- and post-intervention values in the study process.	6 month
Primary	Body mass index (kg/m2)	Body mass index is important for metabolic control of diabetic patients. For this outcome weight and height of patients were measured. Then body mass index was calculated by the formula (weight (kilogram) / height (meter) x height (meter)). Body mass index were recorded kilogram/meter2.	6 month
Primary	Blood pressure level (mmHg)	Blood pressure levels were recorded milimeters mercury. Systolic and Diastolic Blood Pressure levels were measured both. This outcome is essential for macrovasculer complications.	6 month
Primary	Costs via frequency of complication-related hospital admissions	To calculate the cost of hospitalization for each patient, consumables (blood glucose measuring equipment, wound care products, wound cover, sterile gloves, catheter, urine bag, pen needle, infusion pump set) and time spent by the nurse (30 minutes for each patient) were determined. The cost of the time spent by the nurse was based on a new graduate nurse's salary and was calculated by using the formula '' salary ($)/ working time of May 2017 x 0.5 hours''.	6 month