The Effect of Theory-Based Education on Patient Empowerment and Self-Efficacy in Patients With Type 2 Diabetes

May 6, 2024 updated by: Sakarya University

The Effect of Education Given to Diabetes Patients According to the Planned Behavior Theory on Patient Empowerment and Self-Efficacy: A Single-Blind Randomized Controlled Trial

It is essential to manage the disease to prevent and reduce complications and mortality in patients with diabetes. Adequate information and options should be provided to patients by healthcare providers so that patients can make informed choices. Patient education is a patient empowerment process designed to enable patients to be responsible for their health. With this study, it is considered essential to educate diabetic patients according to the theory of planned behavior and to develop self-efficacy by contributing to patient empowerment in this way.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

98

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
    • Serdivan
      • Sakarya, Serdivan, Turkey, 54000
        • Sakarya University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Volunteering to participate in the study
  • 40 years and older
  • Diagnosed with type 2 DM at least 1 year ago
  • Treated at the hospital where the study will be conducted
  • Using antidiabetic agents
  • No communication problem
  • Contactable by phone

Exclusion Criteria:

  • Those who do not meet the inclusion criteria for the study
  • Participants who did not give consent at any stage of the study and left

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention
Behavioral: Application of The Theory of Planned Behaviour for Diabetes
In the study, diabetes education consisting of a total of 4 sessions structured according to the Planned Behavior Theory will be applied to the intervention group, and a standard diabetes education consisting of a single session containing information about diabetes on the website of the Ministry of Health will be applied to the control group. The training will be given face-to-face in groups of 10-15 people. After the training, the participants will be monitored for 3 months. To increase patient empowerment and self-efficacy, the intervention group will be followed up by phone calls every 15 days to increase motivation and answer questions.
No Intervention: Control

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patient Empowerment Scale
Time Frame: 2 weeks
The scale consists of 37 items in total. Scale is graded in a 5-point Likert type, and in total, the lowest 37 and the highest 185 points are taken. There is an opposite item in the scale. This applied to individuals over the age of 18 who receive long-term care services.
2 weeks
Diabetes Management Self-Efficacy Scale for Patients with Type 2 Diabetes
Time Frame: 2 weeks
The scale consists of 20 items in total. The scale is scored as a Likert type (1=Never, 2=Rarely, 3=Sometimes, 4=Often, 5=Always), and the lowest score from the scale is 20 and the highest score is 100.
2 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Blood Glucose Level
Time Frame: 3 months
A condition in which the blood glucose level is above normal. Hyperglycemia is mentioned when fasting blood glucose exceeds 100 mg/dl and postprandial blood glucose exceeds 140 mg/dl.
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sakarya University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 16, 2023

Primary Completion (Actual)

June 17, 2023

Study Completion (Actual)

October 26, 2023

Study Registration Dates

First Submitted

June 6, 2023

First Submitted That Met QC Criteria

June 6, 2023

First Posted (Actual)

June 15, 2023

Study Record Updates

Last Update Posted (Actual)

May 7, 2024

Last Update Submitted That Met QC Criteria

May 6, 2024

Last Verified

May 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 13353

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Diabete Type 2

Clinical Trials on Application of The Theory of Planned Behaviour for Diabetes

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Cambodia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe