Self-managementPARADIGM-QNCT06948370
Development and Evaluation of a Culturally Sensitive Structured Diabetes Self-Management Program for People With Type 2 Diabetes Residing in Qatar
A study testing Intervention Name: PARADIGM-Q Diabetes Self-Management Education Program in people with Self-management and Type 2 Diabetes Mellitus (T2DM), run by Ragae Dughmosh.
Trial summary
This study is about helping people in Qatar who have Type 2 Diabetes take better care of their health. Diabetes is a common and growing problem in Qatar, and many people need more support and information to manage it well in their daily lives. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Self-management, Type 2 Diabetes Mellitus (T2DM), Diabetes Self-management
- What is being tested?
- Intervention Name: PARADIGM-Q Diabetes Self-Management Education Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- No sites listed yet
- Study dates
- 20 May 2025to 1 Feb 2027
- 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults aged 18 to 65 years.
- Diagnosed with Type 2 Diabetes Mellitus.
- Most recent HbA1c ≥ 8% (within the last 6 months).
- Fluent in Arabic and/or English.
- Qatari and non-Qatari participants.
- Able and willing to attend group-based education sessions.
Who cannot join
- Diagnosed with any type of diabetes other than Type 2.
- Pregnant women.
- Presence of major diabetes complications (e.g., renal failure, severe retinopathy, blindness, stroke, heart failure, cancer).
- Physical or mental disabilities that would hinder participation in education sessions.
- Age below 18 or above 65 years.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
Suhail Doi, Professor contact
About this study
Official title: The PARADIGM-Q Study: Development and Evaluation of a Culturally Sensitive Problem- and AttributesbAsed DIabetes Self-Management Program for People With Type 2 Diabetes Residing in Qatar
This study is about helping people in Qatar who have Type 2 Diabetes take better care of their health. Diabetes is a common and growing problem in Qatar, and many people need more support and information to manage it well in their daily lives.
Right now, there is a program called DESMOND in Qatar, but it is only available in a few places and can be expensive to run. It also doesn't always work well in the long term. That's why we are creating a new diabetes education program called PARADIGM-Q. This program will be easier to access, more affordable, and designed to match the culture and needs of people living in Qatar.
Read more
The PARADIGM-Q program will teach people how to manage diabetes using real-life examples and group discussions. This method is called Case-Based Learning. It helps people understand their condition better and learn how to make good decisions about food, exercise, medication, and dealing with challenges.
The project will happen in two main phases:
Phase One: Understanding and Creating the Program
In the first part, we'll look at different ways of teaching about diabetes and see if a method called Case-Based Learning (CBL) works well. After that, we'll build a curriculum (a plan for teaching) based on the PARADIGM model. This curriculum, called the PARADIGM-Q program, will use the CBL method to teach. We'll also test this new program with a small group of diabetes educators and people with diabetes to make sure it works well. Their feedback will help me make the program even better.
Phase Two: Testing the Program
In the second part, we'll do a big study using a mix of people from different backgrounds in Qatar who have Type 2 Diabetes. we want to see if the PARADIGM-Q program is better than the program they already have (called DESMOND). we'll look the impact of our new program on different things like how much they know about diabetes, how active they are, their blood sugar levels (HbA1C), and their overall quality of life.
This study could lead to a new standard for diabetes education in Qatar and other countries in the region, helping more people live healthier lives with diabetes.
Read the detailed description
This PhD research project aims to develop and evaluate a culturally sensitive Diabetes Self-Management Education (DSME) program, the PARADIGM-Q, specifically tailored for people with Type 2 Diabetes Mellitus (T2DM) residing in Qatar. With T2DM reaching epidemic levels globally and particulary among Qatar's population(1), there is an urgent need for effective DSME programs that are tailored to the country's needs. Current DSME programs, such as DESMOND-Qatar, have many limitations, including the fact that it is only available in two places, limiting access to many people who could benefit from diabetes education. Furthermore, the certification and recertification of DESMOND educators are rather costly, presenting financial barriers to the scaling up of this model; it is also limited in its long-term effectiveness(2), increasing the need for a sustainable and culturally appropriate solution to enable people with diabetes to self- manage their condition effectively. In this project, I will employ the locally developed PARADIGM model(3) framework to structure the new DSME interventions across two phases. In the initial phase, the focus is on developing a practical working curriculum using this model. This curriculum, named the PARADIGM-Q program, will incorporate the Case-Based Learning (CBL)(4) approach as its teaching delivery method. A systematic review and dose-response meta-analysis of relevant literature related to the optimal characteristics and duration of the program, followed by the development and piloting of the PARADIGM-Q curriculum. The curriculum will be refined through feedback obtained. The second phase involves evaluating the program's effectiveness through a Quasi-Experimental study, comparing it with Qatar's existing Diabetes Education Self-Management for Ongoing and Newly Diagnosed (DESMOND) program. The development of our local novel (PARADIGM-Q) will promote long-term effectiveness and patient adherence by combining the case-based Learning (CBL) approach with PARADIGM model. In addition, it will also emerge as a cost-effective alternative by establishing a central hub for training trainers within the Qatar health system, encompassing PHCC, HMC, Military Health Services, and private sectors. The primary research question is whether a culturally sensitive, case-based DSME program (PARADIGM-Q) can improve clinical and behavioral outcomes more effectively than existing models. This project has the potential to set a new standard for diabetes education in Qatar and the broader Gulf region, offering a scalable, sustainable intervention that aligns with local cultural practices and healthcare needs.
PROJECT STRUCTURE AND RESEARCH APPROACH
OBJECTIVES AND SIGNIFICANCE
Hypothesis:
The primary hypothesis is that implementing a culturally sensitive, case-based and attributes-based diabetes self-management education program (PARADIGM-Q) will significantly improve clinical outcomes, self-management behaviors, and quality of life for people with Type 2 Diabetes Mellitus (T2DM) when compared to the current DESMOND program.
Study Aim:
To Develop a culturally sensitive and well-structured Diabetes Self-Management Education (DSME) Program tailored specifically for individuals with Type 2 Diabetes residing in Qatar. This program will be developed based on the PARADIGM (Problem And attRibutes-bAsed DIabetes self-manaGeMent) model(3).
Objectives
- To Create the curriculum for a culturally sensitive DSME program using Case-Based Learning (CBL) methodology, aligned with the PARADIGM model's core attributes, and tailored to Qatar's cultural variations.
- Pilot study to validate a newly established DSME curriculum for feasibility, comprehensibility, relevance, and cultural sensitivity among diabetes educators and T2DM patients.
- Effectiveness study to determine the impact of the PARADIGM-Q program on clinical outcomes, self-management behaviors, and quality of life compared to the DESMOND program using a robust quasi-experimental design.
METHODOLOGICAL APPROACHES
Type and classification of study:
Several research designs will be used for this study.
Phase One:
- Systematic Review Objective: To examine the durability of standard diabetes self-management education program on glycosylated hemoglobin (HbA1c) levels over time, and to identify optimal DSME characteristics for glycemic control, forming the basis for the PARADIGM-Q curriculum. Methodology: Conduct a rigorous systematic review and dose response meta-analysis of data from existing studies of conventional DSME programs to gather evidence to determine the optimal duration of effect on glycemic control. Expected Outcome: Synthesize findings to inform on the current baseline before we develop and test our new culturally sensitive DSME program. Our study results will then be compared to results from the evidence synthesis on the durability of current programs on glycemic control.
- Curriculum Formulation and Pilot Study Objective: Formulate a core-attributes, problem-based curriculum based on the PARADIGM model, And to collect feedback for refining the curriculum and ensuring it meets the educational and cultural needs of the Qatari population. Methodology Design:
- A mixed methods study design will be used and will involve diabetes educators and participants with T2DM in a pilot study to validate the PARADIGM-Q curriculum.
- Utilize focus group, pre-post assessments and semi-structured interviews with participants diagnosed with T2DM and diabetes educators to gather feedback on the curriculum's comprehensibility, relevance, and cultural sensitivity. Subsequently, refine curriculum components based on the insights obtained. Expected Outcome: A validated and culturally sensitive DSME program curriculum ready for implementation which will be called the PARADIGM-Q program. Sampling:
- Technique: Non-probability quota sampling
- Participants: 20 adults with Type 2 diabetes, divided by gender and language proficiency:
- Male Arabic speakers
- Female Arabic speakers
- Male English speakers
- Female English speakers This is especially relevant as the newly developed (PARADIGM-Q) program aims to address the needs of the multiethnic population residing in Qatar, encompassing individuals proficient in both Arabic and English languages. Curriculum Contents: PARADIGM-Q Program Structure:
- Duration: The PARADIGM-Q program consists of three weekly sessions, each lasting three hours, designed to support effective diabetes management by integrating it into daily life routines.
- Session Content:
- Week 1: Problem Solving
- Week 2: Decision Making and Taking Action.
- Week 3: Resource Utilization, and Patient-Provider Relationships Educational Approach:
- Case-Based Learning (CBL): Each session begins with a case scenario to stimulate discussion, problem-solving, and skills application.
- Interactive Discussions: Each session closes with actionable strategies for taking learned skills back into your daily self-care routine.
- Hands-on Demonstrations: The Facilitator (diabetes educators) aid by using demonstration tools to bridge these gaps. Data Collection and Analysis Quantitative Measures:
- Pre- and Post-Program Assessments: Diabetes Knowledge Questionnaire (DKQ), Problem Areas in Diabetes (PAID) Scale, Ambulatory Glucose Profile (AGP) using a glucose sensor for two weeks pre and post the month of the intervention, and physical activity (monitored by smartwatches). Qualitative Measures:
- Focus Groups: Conducted with T2D participants post-program about the curriculum's relevance, cultural sensitivity, and effectiveness of the educational approach.
- Semi-Structured Interviews: Facilitators and participants will provide insights on session dynamics, instructional methods, and cultural appropriateness. Data Analysis:
- Quantitative data will be analyzed for knowledge gains, stress reduction (PAID), and glycemic variability.
- Qualitative data will undergo thematic analysis to derive insights into program relevance, effectiveness, and cultural fit. Expected Outcomes
- A validated, culturally adapted DSME program (PARADIGM-Q) ready for large-scale implementation.
- Qualitative and quantitative evidence of curriculum effectiveness and cultural resonance. Phase Two:
1- Controlled before-after Quasi-Experimental study Objective: Evaluate the effectiveness of the (PARADIGM-Q) program on various diabetes outcomes among people with T2DM in Qatar.
Expected Outcome: Empirical evidence on the effectiveness of our new culturally sensitive DSME program (PARADIGM-Q) compared to the existing program (DESMOND).
- Being tested
- Intervention Name: PARADIGM-Q Diabetes Self-Management Education Program, Control Arm (DESMOND): DESMOND Diabetes Self-Management Education Program
- Keywords
- Type 2 Diabetes Mellitus, Diabetes self-management, Quasi Experimental trial, systematic review and dose response meta-analysis
- 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.
Intervention Name: PARADIGM-Q Diabetes Self-Management Education ProgramBehavioural
PARADIGM-Q Diabetes Self-Management Education Program This is a culturally sensitive, structured education intervention tailored for adults with Type 2 Diabetes in Qatar. Developed using the PARADIGM model and delivered through a Case-Based Learning (CBL) approach, the program comprises three weekly group sessions of 3.5 hours each. Each session targets key self-management attributes: problem-solving, decision-making, taking action, resource utilization, and patient-provider relationships. The program emphasizes real-life applicability, cultural relevance, and skill-building to support sustainable diabetes self-care.
Control Arm (DESMOND): DESMOND Diabetes Self-Management Education ProgramBehavioural
The DESMOND Diabetes Self-Management Education Program is the standard diabetes education intervention currently offered to newly diagnosed patients with Type 2 Diabetes in Qatar. It is a UK-developed, theory-driven program delivered over two group sessions, each lasting approximately four hours. The program provides structured education on diabetes, lifestyle management, and risk reduction strategies. It does not incorporate case-based learning or cultural tailoring, distinguishing it from the experimental PARADIGM-Q intervention. DESMOND is used here as an active comparator to evaluate the added value of culturally sensitive, problem-based education.
| Study group | Role | What they receive |
|---|---|---|
| PARADIGM-Q Intervention Arm | Experimental | PARADIGM-Q Intervention Arm (Experimental):
Participants in this arm will receive the PARADIGM-Q Diabetes Self-Management Education (DSME) program. This is a culturally sensitive, structured education intervention developed using the PARADIGM model and delivered through Case-Based Learning (CBL). The program consists of three weekly sessions (each lasting 3.5 hours) covering core self-management attributes: problem-solving, decision-making, taking action, resource utilization, and patient-provider relationships. Receives: Behavioral: Intervention Name: PARADIGM-Q Diabetes Self-Management Education Program |
| DESMOND Control Arm | Active comparator | DESMOND Control Arm (Active Comparator) Participants in this arm will receive the DESMOND (Diabetes Education and Self-Management for Ongoing and Newly Diagnosed) program, which is the standard DSME program currently implemented in Qatar. It involves two group sessions (each lasting approximately 4 hours) and focuses on providing theoretical-based diabetes education for ongoing and newly diagnosed Type 2 Diabetes patients. Receives: Behavioral: Control Arm (DESMOND): DESMOND Diabetes Self-Management Education Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Glycated Hemoglobin (HbA1c)
Measurement of HbA1c to assess long-term glycemic control.
Measured: Baseline, 3 months, 6 months, 9 months, 12 months post-intervention
Secondary outcomes (1)
Change in Health-Related Quality of Life
Evaluated using the Appraisal of Diabetes Scale (ADS)
Measured: Baseline and 3, 6, 9, 12 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 posted29 Apr 2025
- Study start20 May 2025 (estimated)
- Primary completion1 Feb 2027 (estimated)
- Study completion1 Feb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Self-managementStudies 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
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- This is a quasi-experimental study employing a parallel assignment model. Participants with Type 2 Diabetes Mellitus will be allocated to either the intervention group receiving the newly developed PARADIGM-Q diabetes self-management education program or the control group receiving the standard DESMOND program. The study aims to compare outcomes across these two groups without individual or health center randomization, using systematic allocation based on predefined inclusion criteria and institutional referral pathways."
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ragae Dughmosh
- Sponsor type
- University, hospital or other
- Collaborators
- Qatar National Research Fund, Hamad Medical Corporation, Primary Health Care Corporation, Qatar, Qatar University
- Responsible party
- Sponsor-investigator, Ragae Dughmosh, Qatar University
- Investigators
- Manal Musallam Othman, PhD, Principal investigator, Hamad Medical Corporation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06948370
- Sponsor's protocol ID
- ARG02-0403-240132
- Acronym
- PARADIGM-Q
- Status last verified
- Apr 2025
- First submitted
- 21 Apr 2025
- Last updated
- 29 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: At this stage, plans for sharing individual participant data (IPD) are under review and subject to ethical, institutional, and regulatory approvals. Data sharing will be considered based on the sensitivity of health information, participant confidentiality, and applicable data protection regulations. A final decision will be made in alignment with institutional policies and the requirements of the funding body.
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The PARADIGM-Q Study: Development and Evaluation of a Culturally Sensitive Problem- and AttributesbAsed DIabetes Self-Management Program for People With Type 2 Diabetes Residing in Qatar
- ClinicalTrials.gov ID
- NCT06948370
- Acronym / sponsor ID
- PARADIGM-Q / ARG02-0403-240132
- Keywords
- Type 2 Diabetes Mellitus, Diabetes self-management, Quasi Experimental trial, systematic review and dose response meta-analysis
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Ragae DughmoshUniversity, hospital or other
- Collaborators
- Qatar National Research Fund, Hamad Medical Corporation, Primary Health Care Corporation, Qatar, Qatar University
- Study start
- 20 May 2025 (estimated)
- Primary completion
- 1 Feb 2027 (estimated)
- Study completion
- 1 Feb 2027 (estimated)
- First posted
- 29 Apr 2025 (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 study is about helping people in Qatar who have Type 2 Diabetes take better care of their health. Diabetes is a common and growing problem in Qatar, and many people need more support and information to manage it well in their daily lives.
Right now, there is a program called DESMOND in Qatar, but it is only available in a few places and can be expensive to run. It also doesn't always work well in the long term. That's why we are creating a new diabetes education program called PARADIGM-Q. This program will be easier to access, more affordable, and designed to match the culture and needs of people living in Qatar.
The PARADIGM-Q program will teach people how to manage diabetes using real-life examples and group discussions. This method is called Case-Based Learning. It helps people understand their condition better and learn how to make good decisions about food, exercise, medication, and dealing with challenges.
The project will happen in two main phases:
Phase One: Understanding and Creating the Program
In the first part, we'll look at different ways of teaching about diabetes and see if a method called Case-Based Learning (CBL) works well. After that, we'll build a curriculum (a plan for teaching) based on the PARADIGM model. This curriculum, called the PARADIGM-Q program, will use the CBL method to teach. We'll also test this new program with a small group of diabetes educators and people with diabetes to make sure it works well. Their feedback will help me make the program even better.
Phase Two: Testing the Program
In the second part, we'll do a big study using a mix of people from different backgrounds in Qatar who have Type 2 Diabetes. we want to see if the PARADIGM-Q program is better than the program they already have (called DESMOND). we'll look the impact of our new program on different things like how much they know about diabetes, how active they are, their blood sugar levels (HbA1C), and their overall quality of life.
This study could lead to a new standard for diabetes education in Qatar and other countries in the region, helping more people live healthier lives with diabetes.
Detailed description
This PhD research project aims to develop and evaluate a culturally sensitive Diabetes Self-Management Education (DSME) program, the PARADIGM-Q, specifically tailored for people with Type 2 Diabetes Mellitus (T2DM) residing in Qatar. With T2DM reaching epidemic levels globally and particulary among Qatar's population(1), there is an urgent need for effective DSME programs that are tailored to the country's needs. Current DSME programs, such as DESMOND-Qatar, have many limitations, including the fact that it is only available in two places, limiting access to many people who could benefit from diabetes education. Furthermore, the certification and recertification of DESMOND educators are rather costly, presenting financial barriers to the scaling up of this model; it is also limited in its long-term effectiveness(2), increasing the need for a sustainable and culturally appropriate solution to enable people with diabetes to self- manage their condition effectively. In this project, I will employ the locally developed PARADIGM model(3) framework to structure the new DSME interventions across two phases. In the initial phase, the focus is on developing a practical working curriculum using this model. This curriculum, named the PARADIGM-Q program, will incorporate the Case-Based Learning (CBL)(4) approach as its teaching delivery method. A systematic review and dose-response meta-analysis of relevant literature related to the optimal characteristics and duration of the program, followed by the development and piloting of the PARADIGM-Q curriculum. The curriculum will be refined through feedback obtained. The second phase involves evaluating the program's effectiveness through a Quasi-Experimental study, comparing it with Qatar's existing Diabetes Education Self-Management for Ongoing and Newly Diagnosed (DESMOND) program. The development of our local novel (PARADIGM-Q) will promote long-term effectiveness and patient adherence by combining the case-based Learning (CBL) approach with PARADIGM model. In addition, it will also emerge as a cost-effective alternative by establishing a central hub for training trainers within the Qatar health system, encompassing PHCC, HMC, Military Health Services, and private sectors. The primary research question is whether a culturally sensitive, case-based DSME program (PARADIGM-Q) can improve clinical and behavioral outcomes more effectively than existing models. This project has the potential to set a new standard for diabetes education in Qatar and the broader Gulf region, offering a scalable, sustainable intervention that aligns with local cultural practices and healthcare needs.
PROJECT STRUCTURE AND RESEARCH APPROACH
OBJECTIVES AND SIGNIFICANCE
Hypothesis:
The primary hypothesis is that implementing a culturally sensitive, case-based and attributes-based diabetes self-management education program (PARADIGM-Q) will significantly improve clinical outcomes, self-management behaviors, and quality of life for people with Type 2 Diabetes Mellitus (T2DM) when compared to the current DESMOND program.
Study Aim:
To Develop a culturally sensitive and well-structured Diabetes Self-Management Education (DSME) Program tailored specifically for individuals with Type 2 Diabetes residing in Qatar. This program will be developed based on the PARADIGM (Problem And attRibutes-bAsed DIabetes self-manaGeMent) model(3).
Objectives
- To Create the curriculum for a culturally sensitive DSME program using Case-Based Learning (CBL) methodology, aligned with the PARADIGM model's core attributes, and tailored to Qatar's cultural variations.
- Pilot study to validate a newly established DSME curriculum for feasibility, comprehensibility, relevance, and cultural sensitivity among diabetes educators and T2DM patients.
- Effectiveness study to determine the impact of the PARADIGM-Q program on clinical outcomes, self-management behaviors, and quality of life compared to the DESMOND program using a robust quasi-experimental design.
METHODOLOGICAL APPROACHES
Type and classification of study:
Several research designs will be used for this study.
Phase One:
- Systematic Review Objective: To examine the durability of standard diabetes self-management education program on glycosylated hemoglobin (HbA1c) levels over time, and to identify optimal DSME characteristics for glycemic control, forming the basis for the PARADIGM-Q curriculum. Methodology: Conduct a rigorous systematic review and dose response meta-analysis of data from existing studies of conventional DSME programs to gather evidence to determine the optimal duration of effect on glycemic control. Expected Outcome: Synthesize findings to inform on the current baseline before we develop and test our new culturally sensitive DSME program. Our study results will then be compared to results from the evidence synthesis on the durability of current programs on glycemic control.
- Curriculum Formulation and Pilot Study Objective: Formulate a core-attributes, problem-based curriculum based on the PARADIGM model, And to collect feedback for refining the curriculum and ensuring it meets the educational and cultural needs of the Qatari population. Methodology Design:
- A mixed methods study design will be used and will involve diabetes educators and participants with T2DM in a pilot study to validate the PARADIGM-Q curriculum.
- Utilize focus group, pre-post assessments and semi-structured interviews with participants diagnosed with T2DM and diabetes educators to gather feedback on the curriculum's comprehensibility, relevance, and cultural sensitivity. Subsequently, refine curriculum components based on the insights obtained. Expected Outcome: A validated and culturally sensitive DSME program curriculum ready for implementation which will be called the PARADIGM-Q program. Sampling:
- Technique: Non-probability quota sampling
- Participants: 20 adults with Type 2 diabetes, divided by gender and language proficiency:
- Male Arabic speakers
- Female Arabic speakers
- Male English speakers
- Female English speakers This is especially relevant as the newly developed (PARADIGM-Q) program aims to address the needs of the multiethnic population residing in Qatar, encompassing individuals proficient in both Arabic and English languages. Curriculum Contents: PARADIGM-Q Program Structure:
- Duration: The PARADIGM-Q program consists of three weekly sessions, each lasting three hours, designed to support effective diabetes management by integrating it into daily life routines.
- Session Content:
- Week 1: Problem Solving
- Week 2: Decision Making and Taking Action.
- Week 3: Resource Utilization, and Patient-Provider Relationships Educational Approach:
- Case-Based Learning (CBL): Each session begins with a case scenario to stimulate discussion, problem-solving, and skills application.
- Interactive Discussions: Each session closes with actionable strategies for taking learned skills back into your daily self-care routine.
- Hands-on Demonstrations: The Facilitator (diabetes educators) aid by using demonstration tools to bridge these gaps. Data Collection and Analysis Quantitative Measures:
- Pre- and Post-Program Assessments: Diabetes Knowledge Questionnaire (DKQ), Problem Areas in Diabetes (PAID) Scale, Ambulatory Glucose Profile (AGP) using a glucose sensor for two weeks pre and post the month of the intervention, and physical activity (monitored by smartwatches). Qualitative Measures:
- Focus Groups: Conducted with T2D participants post-program about the curriculum's relevance, cultural sensitivity, and effectiveness of the educational approach.
- Semi-Structured Interviews: Facilitators and participants will provide insights on session dynamics, instructional methods, and cultural appropriateness. Data Analysis:
- Quantitative data will be analyzed for knowledge gains, stress reduction (PAID), and glycemic variability.
- Qualitative data will undergo thematic analysis to derive insights into program relevance, effectiveness, and cultural fit. Expected Outcomes
- A validated, culturally adapted DSME program (PARADIGM-Q) ready for large-scale implementation.
- Qualitative and quantitative evidence of curriculum effectiveness and cultural resonance. Phase Two:
1- Controlled before-after Quasi-Experimental study Objective: Evaluate the effectiveness of the (PARADIGM-Q) program on various diabetes outcomes among people with T2DM in Qatar.
Expected Outcome: Empirical evidence on the effectiveness of our new culturally sensitive DSME program (PARADIGM-Q) compared to the existing program (DESMOND).
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This is a quasi-experimental study employing a parallel assignment model. Participants with Type 2 Diabetes Mellitus will be allocated to either the intervention group receiving the newly developed PARADIGM-Q diabetes self-management education program or the control group receiving the standard DESMOND program. The study aims to compare outcomes across these two groups without individual or health center randomization, using systematic allocation based on predefined inclusion criteria and institutional referral pathways."
| Arm | Type | Receives |
|---|---|---|
| PARADIGM-Q Intervention Arm | Experimental | Behavioral: Intervention Name: PARADIGM-Q Diabetes Self-Management Education ProgramPARADIGM-Q Intervention Arm (Experimental): Participants in this arm will receive the PARADIGM-Q Diabetes Self-Management Education (DSME) program. This is a culturally sensitive, structured education intervention developed using the PARADIGM model and delivered through Case-Based Learning (CBL). The program consists of three weekly sessions (each lasting 3.5 hours) covering core self-management attributes: problem-solving, decision-making, taking action, resource utilization, and patient-provider relationships. |
| DESMOND Control Arm | Active comparator | Behavioral: Control Arm (DESMOND): DESMOND Diabetes Self-Management Education ProgramDESMOND Control Arm (Active Comparator) Participants in this arm will receive the DESMOND (Diabetes Education and Self-Management for Ongoing and Newly Diagnosed) program, which is the standard DSME program currently implemented in Qatar. It involves two group sessions (each lasting approximately 4 hours) and focuses on providing theoretical-based diabetes education for ongoing and newly diagnosed Type 2 Diabetes patients. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Adults aged 18 to 65 years.
- Diagnosed with Type 2 Diabetes Mellitus.
- Most recent HbA1c ≥ 8% (within the last 6 months).
- Fluent in Arabic and/or English.
- Qatari and non-Qatari participants.
Key exclusion criteria (5 listed)
- Diagnosed with any type of diabetes other than Type 2.
- Pregnant women.
- Presence of major diabetes complications (e.g., renal failure, severe retinopathy, blindness, stroke, heart failure, cancer).
- Physical or mental disabilities that would hinder participation in education sessions.
- Age below 18 or above 65 years.
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 |
|---|---|---|
| Intervention Name: PARADIGM-Q Diabetes Self-Management Education ProgramPARADIGM-Q Diabetes Self-Management Education Program This is a culturally sensitive, structured education intervention tailored for adults with Type 2 Diabetes in Qatar. Developed using the PARADIGM model and delivered through a Case-Based Learning (CBL) approach, the program comprises three weekly group sessions of 3.5 hours each. Each session targets key self-management attributes: problem-solving, decision-making, taking action, resource utilization, and patient-provider relationships. The program emphasizes real-life applicability, cultural relevance, and skill-building to support sustainable diabetes self-care. | Behavioural | PARADIGM-Q Intervention Arm |
| Control Arm (DESMOND): DESMOND Diabetes Self-Management Education ProgramThe DESMOND Diabetes Self-Management Education Program is the standard diabetes education intervention currently offered to newly diagnosed patients with Type 2 Diabetes in Qatar. It is a UK-developed, theory-driven program delivered over two group sessions, each lasting approximately four hours. The program provides structured education on diabetes, lifestyle management, and risk reduction strategies. It does not incorporate case-based learning or cultural tailoring, distinguishing it from the experimental PARADIGM-Q intervention. DESMOND is used here as an active comparator to evaluate the added value of culturally sensitive, problem-based education. | Behavioural | DESMOND Control Arm |
Primary outcome
Change in Glycated Hemoglobin (HbA1c)
Time frame: Baseline, 3 months, 6 months, 9 months, 12 months post-intervention
Measurement of HbA1c to assess long-term glycemic control.
1 secondary outcome
Change in Health-Related Quality of Life
Time frame: Baseline and 3, 6, 9, 12 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 29 Apr 2025.
- Individual participant dataSharing planned: Undecided. At this stage, plans for sharing individual participant data (IPD) are under review and subject to ethical, institutional, and regulatory approvals. Data sharing will be considered based on the sensitivity of health information, participant confidentiality, and applicable data protection regulations. A final decision will be made in alignment with institutional policies and the requirements of the funding body.
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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.
Suhail Doi, Professor contact
Manal Musallam Othman, PhD principal investigator
Hamad Medical Corporation
Questions about this trial
What is this clinical trial studying?
A study testing Intervention Name: PARADIGM-Q Diabetes Self-Management Education Program in people with Self-management and Type 2 Diabetes Mellitus (T2DM), run by Ragae Dughmosh.
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 5 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 29 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
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 Ragae Ahmad Dughmosh, PhD Student (55019923, rd1806208@qu.edu.qa), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Glycated Hemoglobin (HbA1c) (time frame: Baseline, 3 months, 6 months, 9 months, 12 months post-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 29 Apr 2025.