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NCT Number: NCT07571590

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ministry of Health Primary Healthcare Centers

Jerash, Dours, 009627, Jordan

Location contact

Jawad AHMAD ABU-SHENNAR, Asst.Prof.Dr

CONTACT

[email protected]

0779084560

Jawad AHMAD ABU-SHENNAR, Asst.Prof.Dr

PRINCIPAL_INVESTIGATOR

CONTACT

[email protected]

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Self-Efficacy-Based Educational Program

Behavioral

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

Other outcomes

  1. 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).

Study contacts

Contact information is provided by the study sponsor or research team.

Jawad ABU-SHENNAR, Asst.Prof.Dr

CONTACT

[email protected]

+962779084560

Sponsors and collaborators

Lead sponsor

Jerash Private University

Other

Registry information

Official study title

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

Acronym: T2DM-SM-QOL-

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
May 6, 2026
Registry last updated
May 6, 2026

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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