Effect of HBM Based Education on Glycemic Control of Type 2 Diabates Patients

The Effect of Health Belief Model and Health Literacy Level Based Education and Counseling on Glycemic Control in Type 2 Diabetes Patients

This pre-post-test randomized controlled (parallel group) experimental design study aimed to determine the effect of education based on health belief model and health literacy level of patients with type 2 diabetes on disease management. Study was carried out in Isparta Davraz Family Health Centre between June 17, 2019 and March 02, 2020. Sample consisted of 120 patients with type 2 diabetes, selected by simple randomization method, including 60 patients for the intervention group and 60 patients for the control group.

Patients in intervention and control were also sub-grouped according to their health literacy level. The intervention group was given training based on the health belief model with groups of 10-12-13 people every week for 6 weeks in the Family Health Center, followed by telephone counseling in the following 6 weeks and follow-up for 12 weeks. Patients in the control group were assessed at the first interview and the last interview, received routine health care, and no intervention was performed during the research. "Patient Data Form", "Health Literacy Scale Among Diabetes Patients", "Health Belief Model Scale in Diabetes Patients" and "Type 2 Diabetes Self-Efficacy Scale" used for data collection. Data were collected both on the first day of the study and in the 24th week.

Study Overview

• Status: Completed
• Conditions: Type 2 Diabetes
• Intervention / Treatment: Behavioral: Health Belief Model and Health Literacy Level based Education and Counseling

• Study Type: Interventional
• Enrollment (Actual): 120
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Ankara, Turkey, 06230
    • Hacettepe University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Diagnosis of type 2 Diabates Mellitus at least for a year
• Literate

Exclusion Criteria:

• Problems with vision and hearing

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention; The intervention group was given training based on the health belief model with groups of 10-12-13 people every week for 6 weeks in the Family Health Center, followed by telephone counseling in the following 6 weeks and follow-up for 12 weeks.	Behavioral: Health Belief Model and Health Literacy Level based Education and Counseling; Patients given education and counseling constructed with health belief model (perceived susceptibility, perceived severity, perceived benefits, perceived barriers, cue to action, self-efficacy). The constructed education given through groups dichotomised by health literacy levels (low/high). Groups of 11-13, had weekly educations for 6 weeks, 6 weeks of counselling and 12 week of follow-up.
No Intervention: Control; Patients in the control group were assessed at the first interview and the last interview, received routine health care, and no intervention was performed during the research.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Glycemic Control Change	HbA1C-Change from Baseline HbA1C at 6 months	pre-test (week 1), post-test (week 24)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Health Belief Model Questionnaire	Change in perceived severity, perceived susceptibility, perceived benefits, perceived barriers scores	pre-test (week 1), post-test (week 24)
Self-Efficacy Questionnaire	Change from Baseline self-efficacy level scores at 6 months	pre-test (week 1), post-test (week 24)

Collaborators and Investigators

• Sponsor: Hacettepe University
• Investigators: Principal Investigator: İmatullah Akyar, Hacettepe University

Publications and helpful links

General Publications

• Agrali H, Akyar I. The effect of health literacy-based, health belief-constructed education on glycated hemoglobin (HbA1c) in people with type 2 diabetes: A randomized controlled study. Prim Care Diabetes. 2022 Feb;16(1):173-178. doi: 10.1016/j.pcd.2021.12.010. Epub 2021 Dec 31.

Study record dates

Study Major Dates

• Study Start (Actual): June 17, 2019
• Primary Completion (Actual): March 2, 2020
• Study Completion (Actual): March 2, 2020

Study Registration Dates

• First Submitted: December 14, 2020
• First Submitted That Met QC Criteria: December 15, 2020
• First Posted (Actual): December 21, 2020

Study Record Updates

• Last Update Posted (Actual): December 21, 2020
• Last Update Submitted That Met QC Criteria: December 15, 2020
• Last Verified: December 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2
• Other Study ID Numbers: 16969557-1072

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No