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

Type 2 Diabetes Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04677127
• Other study ID #: 16969557-1072
• Status: Completed
• Phase: N/A
• Start date: June 17, 2019
• Est. completion date: March 2, 2020

Study information

• Verified date: December 2020
• Source: Hacettepe University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: March 2, 2020
• Est. primary completion date: March 2, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

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

• Literate

Exclusion Criteria:

• Problems with vision and hearing

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2
• Type 2 Diabetes

Intervention

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.

Locations

Country	Name	City	State
Turkey	Hacettepe University	Ankara

Sponsors (1)

Lead Sponsor	Collaborator
Hacettepe University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Glycemic Control Change	HbA1C-Change from Baseline HbA1C at 6 months	pre-test (week 1), post-test (week 24)
Secondary	Health Belief Model Questionnaire	Change in perceived severity, perceived susceptibility, perceived benefits, perceived barriers scores	pre-test (week 1), post-test (week 24)
Secondary	Self-Efficacy Questionnaire	Change from Baseline self-efficacy level scores at 6 months	pre-test (week 1), post-test (week 24)