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Not yet recruiting 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

No phase Interventional Diabetes Mellitus Type 2

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Self-Efficacy-Based Educational Program.
Who it may be relevant to
Registry conditions: Diabetes Mellitus Type 2. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Jordan
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official 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

Overview

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.

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.

Interventions

  • 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, grou

Primary outcome measures

  • Diabetes Self-Management Behaviors Measured Using the Diabetes Self-Management Questionnaire (DSMQ) [Time frame: Baseline and 3 months after intervention]
Secondary outcome measures (1)
  • Diabetes Knowledge Measured Using the Diabetes Knowledge Questionnaire (DKQ) [Time frame: Baseline and 3 months post-intervention]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Other

Study locations

Jordan · 1 center
  • Ministry of Health Primary Healthcare Centers — Jerash

Identifiers

NCT: NCT07571590 · T2DM-SM-QOL-RCT-2026

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗