The Effect of Family Support on Diabetes Patients' Health Beliefs, Behavioral and Metabolic Results

NCT04883424 | Completed DMC

• 1 other identifier: B.30.2.ODM.0.20.08 / 262-320
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 1

Brief Summary

This study, designed according to the randomized pre-test and post-test control group experimental model, will be carried out with the patients who apply to the Diabetes Education Unit of Samsun Training and Research Hospital The universe of the study will consist of adult patients between the ages of 20-65 among the diabetic patients who apply to Samsun Training and Research Hospital Diabetes Education Unit. The sample of the study will consist of 100 diabetic patients who comply with the selection criteria and volunteer to participate in the study. The average scores of Hensarling's Diabetes Family Support Scale in Diabetes Patients were determined as 64.12, with an error margin of %5% and a 95% confidence interval, with a sample size of 80% with a sample size of 35 patients for each group, a total of 70 patients. Considering the participant losses during the project, 50 diabetic patients (experiment = 50, control = 50) for each group were determined as a total sample group of 100 diabetic patients with 50% reserve. Personal questionnaire prepared by the researcher in line with the literature, Health Belief Model Scale in Diabetes Patients, Hensarling's Diabetes Family Support Scale and Diabetes Attitude Scale will be used. The purpose of the study will be explained to the diabetic patients who apply to Samsun Training and Research Hospital Diabetes Education Unit and the study will be carried out with diabetic patients who agree to participate in the study. Diabetes patients will be divided into experimental and control groups by Simple Random Method. A training program will be applied to the diabetic patient and their family members included in the experimental group. After the training, a reminder text message will be sent to their phones twice a week for three months and they will be called once a month. Three months after the end of the training, the control will be called for examination.

Conditions

Family Members; Diabetes Mellitus

Keywords

Family support; Diabetics; Health belief model; Diabet training

Outcome Measures

Primary Outcomes (5)

• Health Belief Model Scale in Diabetes Patients

  Health Belief Model Scale in Diabetes Patients: This scale; It is the "Health Belief Model Scale in Diabetes" form adapted by Tan in 2004 for Type 2 diabetes patients and adapted into Turkish in 2007 by Kartal and Ozsoy. The model in the scale has 5 sub-dimensions. In the evaluation of the scale, Likert type scoring with scale items between 1 and 5; "Strongly disagree" (1), "disagree" (2), "undecided" (3), "agree" (4), "strongly agree" (5). The scale consists of 33 items and five main sub-dimensions: perceived sensitivity (4 items), perceived severity (3 items), perceived usefulness (7 items), perceived barriers (9 items), and recommended health-related activities (10 items). A minimum of 33 and a maximum of 165 points can be obtained on the scale. In the posttest, it is aimed to increase the scale score in perceived sensitivity, perceived seriousness, perceived benefit and recommended activities related to health, and decrease the perceived barriers score.

  3 months

• Hensarling's Diabetes Family Support Scale

  This scale determined 4 sub-dimensions of "Diabetes Family Support": empathic support (9 items), encouragement (7 items), facilitative support (6 items) and sharing support (2 items). A total of 24 questions are evaluated over 5 options. These options are "Never", "Almost Never", "Sometimes", "Most of the time", "Always". The lowest possible score for Hensarling's Diabetes Family Support Scale is zero (0) and the highest possible total score: ninetysix (96). The closer the Hensarling's Diabetes Family Support Scale total score is to the highest possible score of 96, the individual's perceived family support is expected. The closer the Hensarling's Diabetes Family Support Scale total score is to 0, the less family support is perceived. In the posttests, it is aimed to increase the score obtained from this scale.

  3 months

• HbA1c

  HbA1c values of diabetic patients will be recorded before pre-tests. For these measurements, the latest examinations made in the hospital will be used. It is expected that the HbA1c values of diabetic patients will decrease in the posttest at the end of the third month.

  3 months

• Fasting Blood Glucose

  Before the pre-tests, the fasting blood glucose value of diabetic patients will be recorded. For these measurements, the latest examinations made in the hospital will be used. It is expected that the HbA1c values of diabetic patients will decrease in the posttest at the end of the third month.

  3 months

• Diabetes Attitude Scale

  The seven subgroups covered by the scale are special education needs, attitude towards patient compliance, severity of type 2 diabetes, blood glucose control and complications, the effect of diabetes on the patient's life, attitude towards patient autonomy and attitude towards team care. Scale items were scored with Likert type scoring ranging from 1 to 5. Score\> 3 indicates positive attitude, score 3 indicates negative attitude. Increasing the score to 5 or decreasing to 1 strengthens the attitude in that direction. In the posttests, it is aimed to increase the diabetes attitude scale scores of family members in a positive way.

  3 months

Study Arms (2)

Diabetes Education Program Based on Health Belief Model

EXPERIMENTAL

Experimental group After the diabetic patients were determined according to the research criteria, they were randomly divided into intervention and control groups. First, pre-tests were applied to diabetics and family members in the experimental group. Diabetes Education Program Based on Health Belief Model It will be administered in two sessions to people with diabetes and their family members. This program; definition of diabetes, the importance of healthy nutrition in diabetes, the importance of exercise, the importance of regular medication, fingertip blood glucose measurement, acute and chronic problems that may develop in diabetic patients, diabetic foot care, personal self-care and family support. A reminder text message will be sent twice a week to diabetics and family members in the intervention group to manage their diabetes well. Once a month, both the diabetic patient and their family member will be called by phone for counseling.

Behavioral: Diabetes Education Program Based on Health Belief Model

Control Group

NO INTERVENTION

First of all, pre-tests will be applied to diabetic patients in the control group. Diabetics in this group will not be intervened and their final tests will be made 3 months after the pre-test.

Interventions

Diabetes Education Program Based on Health Belief Model BEHAVIORAL

After the application, increase in family support and decrease in blood sugar levels are expected in diabetic patients. Family members' diabetic attitudes are expected to increase.

Diabetes Education Program Based on Health Belief Model

Eligibility Criteria

• Age: 20 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Having been diagnosed with Type 2 Diabetes in the last 6 months
• Living in Samsun
• Being between the ages of 20-70
• HbA1c ≥ 6.5%
• Understanding and speaking Turkish
• Owning a smartphone and communicating with the phone
• Having blood glucose measurement tools at home
• Volunteering to participate in study with a family member of their choice

You may not qualify if:

• Being pregnant
• Having advanced or terminal disease (such as cancer, chronic kidney failure)
• Using an insulin pump
• Being disabled

Sponsors & Collaborators

• Ondokuz Mayıs University: lead

Study Sites (1)

Samsun Training and Research Hospital

Samsun, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• İlknur AYDIN AVCI, Prof

  Ondokuz Mayıs University

  STUDY DIRECTOR

• Mustafa Kürşat ŞAHİN, Assoc.Prof

  Ondokuz Mayıs University

  STUDY CHAIR

• Birsen ALTAY, Assoc.Prof

  Ondokuz Mayıs University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Nursing Department

Model Details: Randomized controlled experimental design

Study Record Dates

• First Submitted: April 26, 2021
• First Posted: May 12, 2021
• Study Start: January 1, 2021
• Primary Completion: September 30, 2021
• Study Completion: March 30, 2022
• Last Updated: April 15, 2022

Record last verified: 2022-04

Locations

TU (1)