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

NCT04677127 | Completed DMC

• 1 other identifier: 16969557-1072
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Type 2 Diabetes

Outcome Measures

Primary Outcomes (1)

• Glycemic Control Change

  HbA1C-Change from Baseline HbA1C at 6 months

  pre-test (week 1), post-test (week 24)

Secondary Outcomes (2)

• Health Belief Model Questionnaire

  pre-test (week 1), post-test (week 24)

• Self-Efficacy Questionnaire

  pre-test (week 1), post-test (week 24)

Study Arms (2)

Intervention

EXPERIMENTAL

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

Control

NO INTERVENTION

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.

Interventions

Health Belief Model and Health Literacy Level based Education and Counseling BEHAVIORAL

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.

Intervention

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

• Problems with vision and hearing

Sponsors & Collaborators

• Hacettepe University: lead

Study Sites (1)

Hacettepe University

Ankara, 06230, Turkey (Türkiye)

Location

Related Publications (1)

• 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.

  PMID: 34980562 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Health Belief Model; Counseling

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Models, Theoretical; Investigative Techniques; Models, Psychological; Mental Health Services; Behavioral Disciplines and Activities; Community Health Services; Health Services; Health Care Facilities Workforce and Services

Study Officials

• İmatullah Akyar

  Hacettepe University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor

Study Record Dates

• First Submitted: December 14, 2020
• First Posted: December 21, 2020
• Study Start: June 17, 2019
• Primary Completion: March 2, 2020
• Study Completion: March 2, 2020
• Last Updated: December 21, 2020

Record last verified: 2020-12

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)