Effectiveness of a Self-Efficacy Based Educational Program on Glycemic Self-Monitoring, Diabetes Self-Management Knowledge, and Health-Related Quality of Life Among Adults With Type 2 Diabetes Mellitus (T2DM-SM-QOL-)

April 30, 2026 updated by: JAWAD AHMAD ABU-SHENNAR, Jerash Private University

Effectiveness of a Self-Efficacy-Based Educational Program on Glycemic Self-Monitoring, Diabetes Self-Management Knowledge, and Health-Related Quality of Life Among Adults With Type 2 Diabetes Mellitus: A Randomized Controlled Trial

This randomized controlled trial aims to evaluate the effectiveness of a self-efficacy-based educational program on glycemic self-monitoring, diabetes self-management knowledge, and health-related quality of life among adults with Type 2 Diabetes Mellitus. Participants will be randomly assigned to either an intervention group receiving the educational program or a control group receiving standard care.

The educational program is designed to enhance patients' confidence (self-efficacy) in managing their condition, including blood glucose monitoring, adherence to treatment, lifestyle modification, and self-care practices. Outcomes will be assessed using validated tools to measure improvements in self-monitoring behaviors, knowledge, and quality of life.

The findings of this study are expected to provide evidence on the effectiveness of educational interventions in improving diabetes management and patient outcomes.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

Type 2 Diabetes Mellitus is a chronic metabolic disorder that requires continuous self-management, including blood glucose monitoring, medication adherence, diet control, and lifestyle modification. Poor self-management is associated with increased risk of complications and reduced quality of life.

Self-efficacy, defined as an individual's belief in their ability to perform specific behaviors, plays a critical role in diabetes self-management. Educational interventions based on self-efficacy theory have shown potential in improving patients' confidence and ability to manage their condition effectively.

This study is a randomized controlled trial designed to evaluate the effectiveness of a self-efficacy-based educational program among adults with Type 2 Diabetes Mellitus. A total of 400 participants will be recruited and randomly assigned to either the intervention group or the control group.

Participants in the intervention group will receive a structured educational program focusing on enhancing self-efficacy related to glycemic self-monitoring, diabetes knowledge, and self-care behaviors. The program will include interactive sessions, practical demonstrations, and educational materials. The control group will receive standard care provided by healthcare services.

Data will be collected at baseline and after the intervention using validated instruments to assess glycemic self-monitoring practices, diabetes self-management knowledge, and health-related quality of life.

The primary outcomes of this study include improvement in glycemic self-monitoring behaviors and diabetes-related knowledge. Secondary outcomes include improvement in health-related quality of life.

The results of this study are expected to contribute to the growing body of evidence supporting the role of self-efficacy-based interventions in chronic disease management and may inform future clinical practice and educational strategies.

Study Type

Interventional

Enrollment (Estimated)

400

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 Contact

Study Locations

  • Jordan
    • Dours
      • Jerash, Dours, Jordan, 009627
        • Ministry of Health Primary Healthcare Centers
        • Contact:
        • Contact:
        • Principal Investigator:
          • Jawad AHMAD ABU-SHENNAR, Asst.Prof.Dr

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

No

Description

Inclusion Criteria:

  • Adults aged 18 years and above
  • Diagnosed with Type 2 Diabetes Mellitus (T2DM)
  • Attending Jordanian Ministry of Health healthcare facilities for at least six months with regular follow-up visits
  • Able to perform or learn self-monitoring of blood glucose (SMBG)
  • Able to use a glucometer independently
  • Willing to participate and provide informed consent

Exclusion Criteria:

  • Patients with Type 1 diabetes mellitus or gestational diabetes
  • Patients with physical or cognitive impairments that limit the ability to perform SMBG independently
  • Pregnant or lactating women
  • Patients with severe medical conditions such as renal failure or cardiovascular instability that may affect participation
  • Patients with other conditions that may hinder study participation
  • Patients who do not provide informed consent
  • Patients who fail to respond to study instruments
  • Patients who participated in similar educational programs within the past six months
  • Patients currently using corticosteroid medications due to their effect on blood glucose levels

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: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Self-Efficacy Educational Program Groups

Participants in this arm will receive a structured self-efficacy-based educational program designed to improve glycemic self-monitoring, diabetes self-management knowledge, and health-related quality of life among adults with Type 2 Diabetes Mellitus. The intervention is based on self-efficacy theory and focuses on enhancing patients' confidence in performing diabetes self-care behaviors.

The program is delivered through structured educational sessions conducted by trained healthcare professionals. It includes interactive lectures, group discussions, demonstrations, and practical training covering blood glucose self-monitoring, medication adherence, dietary management, physical activity, and prevention of diabetes-related complications.

Educational materials such as printed handouts and visual aids are provided to reinforce learning. The intervention is delivered over a defined number of sessions within a specific timeframe.
Behavioral: Self-Efficacy-Based Educational Program

A structured self-efficacy-based educational program designed for adults with Type 2 Diabetes Mellitus to improve glycemic self-monitoring, diabetes self-management knowledge, and health-related quality of life. The program is grounded in self-efficacy theory and aims to enhance patients' confidence in performing diabetes self-care behaviors.

The intervention is delivered through scheduled educational sessions conducted by trained healthcare professionals and includes interactive lectures, group discussions, demonstrations, and practical training. Key topics include blood glucose self-monitoring, medication adherence, dietary management, physical activity, complication prevention, and problem-solving strategies for diabetes self-care.

Educational materials such as printed booklets and visual aids are used to reinforce learning. The program is implemented over a defined number of sessions within a specified period, while the control group receives standard routine care only.
Active Comparator: Control Group

Participants in this arm will receive standard routine care for Type 2 Diabetes Mellitus as provided in usual clinical practice at the healthcare facilities. This includes regular follow-up visits, general medical advice, and standard education related to diabetes management as offered by healthcare providers.

No structured or additional self-efficacy-based educational program will be provided to this group. Participants will continue their usual care without any additional intervention from the research team.
Behavioral: Self-Efficacy-Based Educational Program

A structured self-efficacy-based educational program designed for adults with Type 2 Diabetes Mellitus to improve glycemic self-monitoring, diabetes self-management knowledge, and health-related quality of life. The program is grounded in self-efficacy theory and aims to enhance patients' confidence in performing diabetes self-care behaviors.

The intervention is delivered through scheduled educational sessions conducted by trained healthcare professionals and includes interactive lectures, group discussions, demonstrations, and practical training. Key topics include blood glucose self-monitoring, medication adherence, dietary management, physical activity, complication prevention, and problem-solving strategies for diabetes self-care.

Educational materials such as printed booklets and visual aids are used to reinforce learning. The program is implemented over a defined number of sessions within a specified period, while the control group receives standard routine care only.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Diabetes Self-Management Behaviors Measured Using the Diabetes Self-Management Questionnaire (DSMQ)
Time Frame: Baseline and 3 months after intervention
Change in diabetes self-management behaviors measured using the Diabetes Self-Management Questionnaire (DSMQ). The DSMQ is a 16-item validated self-report instrument developed by Schmitt et al. (2013) to assess diabetes self-care behaviors that influence glycemic control, including glucose management, dietary control, physical activity, and healthcare utilization. Items are rated on a Likert scale, with higher scores indicating better self-management.
Baseline and 3 months after intervention

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Diabetes Knowledge Measured Using the Diabetes Knowledge Questionnaire (DKQ)
Time Frame: Baseline and 3 months post-intervention
Change in diabetes knowledge measured using the Diabetes Knowledge Questionnaire (DKQ). The DKQ is a validated 24-item instrument developed to assess patients' understanding of diabetes management, including causes, symptoms, complications, diet, exercise, medication adherence, and blood glucose control. Items are answered in a Yes/No/Don't know format, with one point awarded for each correct answer. Total scores range from 0 to 24, with higher scores indicating greater diabetes knowledge.
Baseline and 3 months post-intervention

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Health-Related Quality of Life Measured Using the EQ-5D-5L Questionnaire
Time Frame: Baseline and 3 months post-intervention
Change in health-related quality of life measured using the EuroQol 5-Dimension 5-Level (EQ-5D-5L) questionnaire. The EQ-5D-5L includes five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression, each rated on a 5-level scale ranging from no problems to extreme problems. The EQ-5D index score typically ranges from values below 0 (worse than death) to 1 (full health), where higher scores indicate better health-related quality of life. Additionally, overall health status is assessed using the EQ Visual Analog Scale (EQ-VAS), ranging from 0 (worst imaginable health) to 100 (best imaginable health).
Baseline and 3 months post-intervention

Collaborators and Investigators

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

Sponsor

Jerash Private University

Investigators

  • Principal Investigator: Jawad AHMAD ABU-SHENNAR, Asst.Prof.Dr, Jerash University, Faculty of Nursing

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 (Estimated)

May 1, 2026

Primary Completion (Estimated)

May 1, 2026

Study Completion (Estimated)

October 1, 2026

Study Registration Dates

First Submitted

April 24, 2026

First Submitted That Met QC Criteria

April 30, 2026

First Posted (Actual)

May 6, 2026

Study Record Updates

Last Update Posted (Actual)

May 6, 2026

Last Update Submitted That Met QC Criteria

April 30, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • T2DM-SM-QOL-RCT-2026

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Individual participant data (IPD) will not be shared because this study involves human subjects data collected for academic and institutional research purposes. Data confidentiality and participant privacy will be strictly maintained in accordance with ethical guidelines and institutional review board (IRB) requirements. Only aggregated results will be reported and published, and individual-level data will not be made publicly available.

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.

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