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.

Study Overview

• Status: Not yet recruiting
• Conditions: Diabetes Mellitus, Type 2
• Intervention / Treatment: Other: Group education session by DESMOND Program

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.

• Study Type: Interventional
• Enrollment (Estimated): 150
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Qatar
  • Doha, Qatar, 26555
    • Primary Health Care Corporation
    • Contact: PHCC IRB; Phone Number: 40271109 +974 4406 9917; Email: researchsection@phcc.gov.qa

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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; 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
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; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Blood HbA1C %	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
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	before starting the diabetes standard care , after 3, and 6 months of follow up for both arms

Collaborators and Investigators

• Sponsor: Primary Health Care Corporation, Qatar

Study record dates

Study Major Dates

• Study Start (Estimated): October 1, 2024
• Primary Completion (Estimated): September 1, 2025
• Study Completion (Estimated): October 1, 2025

Study Registration Dates

• First Submitted: July 17, 2024
• First Submitted That Met QC Criteria: July 17, 2024
• First Posted (Actual): July 22, 2024

Study Record Updates

• Last Update Posted (Actual): July 22, 2024
• Last Update Submitted That Met QC Criteria: July 17, 2024
• Last Verified: July 1, 2024

More Information

Terms related to this study

• Keywords: Diabetes self management; DESMOND; effect of diabetes self management on glycemic control
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2
• Other Study ID Numbers: PHCCQatar

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: 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.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No