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

NCT ID: NCT04677127

Last Updated: 2020-12-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-06-17

Study Completion Date

2020-03-02

Brief Summary

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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.

Detailed Description

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Conditions

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Type 2 Diabetes

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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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.

Group Type EXPERIMENTAL

Health Belief Model and Health Literacy Level based Education and Counseling

Intervention Type 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.

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* Problems with vision and hearing
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hacettepe University

OTHER

Sponsor Role lead

Responsible Party

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İmatullah Akyar

Associate professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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İmatullah Akyar

Role: PRINCIPAL_INVESTIGATOR

Hacettepe University

Locations

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Hacettepe University

Ankara, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

References

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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.

Reference Type DERIVED
PMID: 34980562 (View on PubMed)

Other Identifiers

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16969557-1072

Identifier Type: -

Identifier Source: org_study_id