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Not yet recruitingNCT06513468Updated Jul 22, 2024

The Value of Adding Group Education (DESMOND Method) to the Standard Primary Care Education Practices in Changing Glycemic Control and Self-care Practices in Adults With Type II Diabetes Mellitus: A Randomized Controlled Intervention Study.

An interventional study of Group education session by DESMOND Program in Diabetes Mellitus, Type 2, sponsored by Primary Health Care Corporation, Qatar. Not yet recruiting at 1 site in Qatar. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-07-22.

Sponsored by Primary Health Care Corporation, Qatar · Not applicable, Interventional, and Other

From the registry’s dates

  • Primary completion was expected by Sep 2025, 1 year 2 months ago, but the record still lists the study as not yet recruiting.
Phase
Not applicable
Study type
Interventional
Enrollment
150
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Study summary

The goal of this clinical trial is to assess the outcome of delivering the health education in a group format using the DESMOND program compared to the standard health education in newly diagnosed adults with type 2 diabetes mellitus . The main questions it aims to answer is:

Does adding group education (DESMOND method) to the standard primary care education practices is effective in changing glycemic control and self-care practices in adults with Type II Diabetes Mellitus .

The enrolled study participants will be randomized to receive either the standard personal health care or group health education (DESMOND) session. questionnaire form measuring diabetes self-care will be administered at baseline together with measurement of HbA1C. These measurements will be repeated after 3 and 6 months of the intervention for both study groups.

Read the detailed description
  1. Objectives: This pilot, single primary healthcare center study is designed to assess the effect of delivering the group health education DESMOND program as an add-on to the standard health education in type 2 diabetic patients.
  2. Design: This is an analytic randomized controlled intervention study for adult patients who are newly diagnosed type II Diabetes Mellitus. The enrolled study participants will be randomized to receive either the standard personal health care (routine diabetes health education services) or a standard group health education (DESMOND) session. A standard questionnaire form measuring diabetes self-care will be administered at baseline together with measurement of HbA1C. These measurements will be repeated after 3 and 6 months of the intervention for both study groups.
  3. Setting :The Family Medicine clinics in Airport Health Center in Primary care, Qatar.
  4. Participants: Newly diagnosed type II Diabetes Mellitus aged more than 18 years.
  5. Intervention: A six-hour structured group education program to be delivered by one certified DESMOND health educator compared with the standard care.
  6. Main outcome measures : Blood HbA1C % at baseline (before starting the diabetes management protocol of PHCC), after 3, and 6 months of follow up. In addition, the Diabetes self-management score (DSMQ) after 3 and 6 months of receiving both the standard personal health education sessions and the tested group education (DESMOND) method.
02

Conditions studied

  • Diabetes Mellitus, Type 2

Keywords

  • Diabetes self management
  • DESMOND
  • effect of diabetes self management on glycemic control
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 150 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

Primary Health Care Corporation, Qatar is the lead sponsor of 3 studies on the registry; 2 are open to participants now.

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

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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

  1. Adult more than 18 years, newly diagnosed Type II diabetes mellitus (within 4 - 6 weeks of diagnosis) attending the Airport Health Care Center.
  2. Not yet receiving any form of standard health education in PHCC.

Exclusion criteria

Exclusion Criteria:

  1. Using diuretics or cancer therapy.
  2. Had enduring mental health problem.
  3. Participants in another research study.
  4. Inability to communicate in Arabic or English language
05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
150 participants (estimated)

Study arms

  • Active comparator
    The standard health education of primary care .

    The first group will receive a standard health education for self-care practices done by attending two appointments in our clinics with the health education and dietitian in a personal session. The HA1C blood test together with completing a brief questionnaire form measuring the Diabetes Self-Care Activities during the past three months will be done after 3 and, 6 months will be done.

    Other: Group education session by DESMOND Program

  • Experimental
    The standard group health education (DESMOND) session

    The second group will attend a group health education using a standard DESMOND method (10-12 patients for each session lasting for 6 hours over one day by certified DESMOND educator in the conference room of the health center). The HA1C blood test together with completing a brief questionnaire form measuring the Diabetes Self-Care Activities during the past three months will be done after 3 and, 6 months will be done.

    Other: Group education session by DESMOND Program

Interventions

  • OtherGroup education session by DESMOND Program

    is a validated structured education program for people with type 2 diabetes and their family members or carers (as appropriate)' This management approach was advised by the National Institute for Health and Care Excellence (NICE) in the UK since 2008. The program consists of a 6-hour face-to-face education session delivered by two trained educators over one day or two half-days to a group of 8-12 people with newly-diagnosed or ongoing type 2 diabetes. Annual reinforcement and review are part of the program , it is delivered as a business and usual in the secondary healthcare system of Qatar. The program is culturally adapted for Qatar considering beliefs and other health festivities.

    Also known as: The Diabetes Education and Self-Management for Ongoing and Newly Diagnosed with Type II diabetes

06

What researchers measure

Primary outcomes

  1. Blood HbA1C %

    before starting the diabetes standard care , after 3, and 6 months of follow up for both arms

    Time frame: before starting the diabetes standard care , after 3, and 6 months of follow up for both arms

  2. The Diabetes self-management score using the (DSMQ)

    The Diabetes self-management score (DSMQ) at baseline , after 3 and 6 months of receiving both the standard personal health education sessions and the tested group education (DESMOND) method

    Time frame: before starting the diabetes standard care , after 3, and 6 months of follow up for both arms

07

Study locations

1 site
  • Primary Health Care Corporation
    Doha, 26555, Qatar
08

References and documents

Individual participant data

Plan to share: No — we will keep participant name and other data confidential. it will be stored confidentially with the researcher only, and he may access to the data or specimens, for further research purpose in future.

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 22, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06513468
Lead sponsor
Primary Health Care Corporation, Qatar
Responsible party
Engy Salah Mohamed Abdelhamed (Consultant Family Medicine, Primary Health Care Corporation, Qatar) — Principal investigator
First posted
Jul 22, 2024
Start date
Oct 2024 (estimated)
Primary completion
Sep 2025 (estimated)
Completion
Oct 2025 (estimated)
Last update
Jul 22, 2024

Oversight

Data monitoring committee
Yes
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 Jul 2024. You cannot join it, but the record below documents what was studied.

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