Diabetes Mellitus Type 2T2DM-SM-QOL-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
A study testing Self-Efficacy-Based Educational Program in people with Diabetes Mellitus Type 2, run by Jerash Private University at 1 site in Jordan.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetes Mellitus Type 2
- What is being tested?
- Self-Efficacy-Based Educational Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- 1 siteJordan
- Study dates
- 1 May 2026to 1 Oct 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Jordan1 site
Ministry of Health Primary Healthcare Centers
Jerash, Dours, 009627
Jawad AHMAD ABU-SHENNAR, Asst.Prof.Dr, 0779084560, JAWAD_0799@YAHOO.COM
JAWAD_0799@YAHOO.COM
About this study
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
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.
- Conditions
- Diabetes Mellitus Type 2
- Being tested
- Self-Efficacy-Based Educational Program
- Keywords
- Glycemic Self-Monitoring, Diabetes Self-Management Knowledge, Quality of Life, Type 2 Diabetes Mellitus
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Self-Efficacy-Based Educational ProgramBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Self-Efficacy-Based Educational Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Baseline and 3 months post-intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2026
- Study start1 May 2026 (estimated)
- Primary completion1 May 2026 (estimated)
- Study completion1 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Mellitus Type 2Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be randomly assigned to either an intervention group receiving the educational program or a control group receiving standard care.
- Masking
- None (open label)
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jerash Private University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, JAWAD AHMAD ABU-SHENNAR, Jerash Private University
- Investigators
- Jawad AHMAD ABU-SHENNAR, Asst.Prof.Dr, Principal investigator, Jerash University, Faculty of Nursing
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07571590
- Sponsor's protocol ID
- T2DM-SM-QOL-RCT-2026
- Acronym
- T2DM-SM-QOL-
- Status last verified
- Apr 2026
- First submitted
- 24 Apr 2026
- Last updated
- 6 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07571590
- Acronym / sponsor ID
- T2DM-SM-QOL- / T2DM-SM-QOL-RCT-2026
- Conditions
- Diabetes Mellitus Type 2
- Keywords
- Glycemic Self-Monitoring, Diabetes Self-Management Knowledge, Quality of Life, Type 2 Diabetes Mellitus
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Jerash Private UniversityUniversity, hospital or other
- Study start
- 1 May 2026 (estimated)
- Primary completion
- 1 May 2026 (estimated)
- Study completion
- 1 Oct 2026 (estimated)
- First posted
- 6 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants will be randomly assigned to either an intervention group receiving the educational program or a control group receiving standard care.
| Arm | Type | Receives |
|---|---|---|
| Self-Efficacy Educational Program Groups | Experimental | Behavioral: Self-Efficacy-Based Educational ProgramParticipants 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. |
| Control Group | Active comparator | Behavioral: Self-Efficacy-Based Educational ProgramParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Self-Efficacy-Based Educational ProgramA 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. | Behavioural | Control Group, Self-Efficacy Educational Program Groups |
Primary outcome
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.
1 secondary outcome
Diabetes Knowledge Measured Using the Diabetes Knowledge Questionnaire (DKQ)
Time frame: Baseline and 3 months post-intervention
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2026.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jawad AHMAD ABU-SHENNAR, Asst.Prof.Dr principal investigator
Jerash University, Faculty of Nursing
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Self-Efficacy-Based Educational Program in people with Diabetes Mellitus Type 2, run by Jerash Private University at 1 site in Jordan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 6 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Jordan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jawad ABU-SHENNAR, Asst.Prof.Dr (+962779084560, JAWAD_0799@YAHOO.COM), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diabetes Self-Management Behaviors Measured Using the Diabetes Self-Management Questionnaire (DSMQ) (time frame: Baseline and 3 months after intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 May 2026.