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NCT Number: NCT06513468

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.

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.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

  • 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.
  • 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.
  • Setting :The Family Medicine clinics in Airport Health Center in Primary care, Qatar.
  • Participants: Newly diagnosed type II Diabetes Mellitus aged more than 18 years.
  • Intervention: A six-hour structured group education program to be delivered by one certified DESMOND health educator compared with the standard care.
  • 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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Using diuretics or cancer therapy.
  • Had enduring mental health problem.
  • Participants in another research study.
  • Inability to communicate in Arabic or English language

Treatment and study plan

Group education session by DESMOND Program

Other

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.

Other names: The Diabetes Education and Self-Management for Ongoing and Newly Diagnosed with Type II diabetes

Primary outcomes

  1. Blood HbA1C %

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

    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)

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

    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

Sponsors and collaborators

Lead sponsor

Primary Health Care Corporation, Qatar

Other Gov

Registry information

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Jul 22, 2024
Registry last updated
Jul 22, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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