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NCT Number: NCT04677127

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

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Key information

Conditions

Type 2 Diabetes Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hacettepe University

Ankara, 06230, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Problems with vision and hearing

Treatment and study plan

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.

Primary outcomes

  1. Glycemic Control Change

    Time frame: pre-test (week 1), post-test (week 24)

    HbA1C-Change from Baseline HbA1C at 6 months

Secondary outcomes

  1. Health Belief Model Questionnaire

    Time frame: pre-test (week 1), post-test (week 24)

    Change in perceived severity, perceived susceptibility, perceived benefits, perceived barriers scores

  2. Self-Efficacy Questionnaire

    Time frame: pre-test (week 1), post-test (week 24)

    Change from Baseline self-efficacy level scores at 6 months

Sponsors and collaborators

Lead sponsor

Hacettepe University

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Dec 21, 2020
Registry last updated
Dec 21, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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