ClinicalTrials.gg
Not yet recruitingNCT07571590T2DM-SM-QOL-Updated May 6, 2026

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

An interventional study of Self-Efficacy-Based Educational Program in Diabetes Mellitus Type 2, sponsored by Jerash Private University. Not yet recruiting at 1 site in Jordan. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-05-06.

Sponsored by Jerash Private University · Not applicable, Interventional, and Other

From the registry’s dates

  • Primary completion was expected by May 2026, 6 months ago, but the record still lists the study as not yet recruiting.
Phase
Not applicable
Study type
Interventional
Enrollment
400
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Diabetes Mellitus Type 2

Keywords

  • Glycemic Self-Monitoring
  • Diabetes Self-Management Knowledge
  • Quality of Life
  • Type 2 Diabetes Mellitus
03

In context

Diabetes Mellitus, Type 2

10,371 studies on the registry are indexed under Diabetes Mellitus, Type 2; 1,406 are open to participants now.

This study's planned enrollment of 400 is above the median of 80 across 8,350 interventional studies indexed under Diabetes Mellitus, Type 2.

Browse Diabetes Mellitus, Type 2 studies →

Lead sponsor

Jerash Private University is the lead sponsor of 8 studies on the registry; 3 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion criteria

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
  • Patients who fail to respond to study instruments
  • Patients who participated in similar educational programs within the past six months
  • Patients currently using medications due to their effect on blood glucose levels
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Corticosteroids (steroids)

Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.

Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.

05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
400 participants (estimated)

Study arms

  • 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

  • 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

Interventions

  • BehavioralSelf-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.

06

What researchers measure

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.

    Time frame: Baseline and 3 months after intervention

Secondary outcomes

  1. Diabetes Knowledge Measured Using the Diabetes Knowledge Questionnaire (DKQ)

    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.

    Time frame: Baseline and 3 months post-intervention

Other outcomes

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

    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).

    Time frame: Baseline and 3 months post-intervention

07

Study locations

1 site
08

References and documents

Individual participant data

Plan to share: No — 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.

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for May 2026; primary completion for May 2026, 0 months later.

Of 2,066 non-industry interventional studies with no phase under Diabetes Mellitus, Type 2, half reached primary completion within 21 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 40. This study's planned 0 months is below that.

Counting every sponsor, half of 2,243 studies reached it within 21 months; a quarter within 10 and three quarters within 39.

How these figures are worked out, and which studies are left out of them.

Registered
Apr 24, 2026
First posted
May 6, 2026
StartEst.
May 1, 2026
Primary completionEst.
May 1, 2026
CompletionEst.
Oct 1, 2026
Last update
May 6, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on May 6, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07571590
Lead sponsor
Jerash Private University
Responsible party
JAWAD AHMAD ABU-SHENNAR (Assistant Professor, Jerash Private University) — Principal investigator
First posted
May 6, 2026
Start date
May 1, 2026 (estimated)
Primary completion
May 1, 2026 (estimated)
Completion
Oct 1, 2026 (estimated)
Last update
May 6, 2026

Study contacts

Jawad ABU-SHENNAR, Asst.Prof.Dr
Contact
JAWAD_0799@YAHOO.COM
+962779084560
Jawad AHMAD ABU-SHENNAR, Asst.Prof.Dr
principal investigator · Jerash University, Faculty of Nursing

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Apr 2026. You cannot join it, but the record below documents what was studied.

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