NCT07571590

Brief Summary

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.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
400

participants targeted

Target at P75+ for not_applicable diabetes-mellitus-type-2

Timeline
5mo left

Started May 2026

Shorter than P25 for not_applicable diabetes-mellitus-type-2

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress4%
May 2026Oct 2026

First Submitted

Initial submission to the registry

April 24, 2026

Completed
7 days until next milestone

Study Start

First participant enrolled

May 1, 2026

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2026

Completed
5 days until next milestone

First Posted

Study publicly available on registry

May 6, 2026

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2026

Expected
Last Updated

May 6, 2026

Status Verified

April 1, 2026

Enrollment Period

Same day

First QC Date

April 24, 2026

Last Update Submit

April 30, 2026

Conditions

Keywords

Glycemic Self-MonitoringDiabetes Self-Management KnowledgeQuality of LifeType 2 Diabetes Mellitus

Outcome Measures

Primary Outcomes (1)

  • Diabetes Self-Management Behaviors Measured Using the Diabetes Self-Management Questionnaire (DSMQ)

    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 Outcomes (1)

  • Diabetes Knowledge Measured Using the Diabetes Knowledge Questionnaire (DKQ)

    Baseline and 3 months post-intervention

Other Outcomes (1)

  • Health-Related Quality of Life Measured Using the EQ-5D-5L Questionnaire

    Baseline and 3 months post-intervention

Study Arms (2)

Self-Efficacy Educational Program Groups

EXPERIMENTAL

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

Control Group

ACTIVE COMPARATOR

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

Interventions

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.

Control GroupSelf-Efficacy Educational Program Groups

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ministry of Health Primary Healthcare Centers

Jerash, Dours, 009627, Jordan

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • Jawad AHMAD ABU-SHENNAR, Asst.Prof.Dr

    Jerash University, Faculty of Nursing

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Jawad ABU-SHENNAR, Asst.Prof.Dr

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Model Details: Participants will be randomly assigned to either an intervention group receiving the educational program or a control group receiving standard care.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

April 24, 2026

First Posted

May 6, 2026

Study Start

May 1, 2026

Primary Completion

May 1, 2026

Study Completion (Estimated)

October 1, 2026

Last Updated

May 6, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

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.

Locations