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
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 200
- Primary Endpoint
- Change in Glycated Hemoglobin (HbA1c)
Study Overview
Brief 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.
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 Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Supportive Care
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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.
Exclusion Criteria
- •Diagnosed with any type of diabetes other than Type
- •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.
Outcomes
Primary Outcomes
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.
Secondary Outcomes
- Change in Health-Related Quality of Life(Baseline and 3, 6, 9, 12 months post-intervention)
Investigators
Ragae Dughmosh
PhD Student
Qatar University