Development and Evaluation of a Culturally Sensitive Structured Diabetes Self-Management Program for People With Type 2 Diabetes Residing in Qatar

NCT06948370 | Not Yet Recruiting

• 1 other identifier: ARG02-0403-240132
• Study Type: interventional
• Target: 200
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Self-management; Type 2 Diabetes Mellitus (T2DM); Diabetes Self-management

Keywords

Type 2 Diabetes Mellitus; Diabetes self-management; Quasi Experimental trial; systematic review and dose response meta-analysis

Outcome Measures

Primary Outcomes (1)

• Change in Glycated Hemoglobin (HbA1c)

  Measurement of HbA1c to assess long-term glycemic control.

  Baseline, 3 months, 6 months, 9 months, 12 months post-intervention

Secondary Outcomes (1)

• Change in Health-Related Quality of Life

  Baseline and 3, 6, 9, 12 months post-intervention

Study Arms (2)

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.

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.

Behavioral: Control Arm (DESMOND): DESMOND Diabetes Self-Management Education Program

Interventions

Intervention Name: PARADIGM-Q Diabetes Self-Management Education Program BEHAVIORAL

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.

PARADIGM-Q Intervention Arm

Control Arm (DESMOND): DESMOND Diabetes Self-Management Education Program BEHAVIORAL

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.

DESMOND Control Arm

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ragae Dughmosh: lead
• Qatar National Research Fund: collaborator
• Hamad Medical Corporation: collaborator
• Primary Health Care Corporation, Qatar: collaborator
• Qatar University: collaborator

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Manal Musallam Othman, PhD

  Hamad Medical Corporation

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ragae Ahmad Dughmosh, PhD Student

CONTACT

55019923; rd1806208@qu.edu.qa

Suhail Doi, Professor

CONTACT

sdoi@qu.edu.qa

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: PhD Student

Model Details: 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."

Study Record Dates

• First Submitted: April 21, 2025
• First Posted: April 29, 2025
• Study Start: May 20, 2025
• Primary Completion (Estimated): February 1, 2027
• Study Completion (Estimated): February 1, 2027
• Last Updated: April 29, 2025

Record last verified: 2025-04