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.

NCT06513468 | Not Yet Recruiting DMC

• 1 other identifier: PHCCQatar
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Diabetes Mellitus, Type 2

Keywords

Diabetes self management; DESMOND; effect of diabetes self management on glycemic control

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (2)

The standard health education of primary care .

ACTIVE COMPARATOR

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

The standard group health education (DESMOND) session

EXPERIMENTAL

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

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.

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

The standard group health education (DESMOND) session; The standard health education of primary care .

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Primary Health Care Corporation, Qatar: lead

Study Sites (1)

Primary Health Care Corporation

Doha, 26555, Qatar

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Self-Management

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Rehabilitation; Health Services; Health Care Facilities Workforce and Services

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Consultant Family Medicine

Model Details: 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

Study Record Dates

• First Submitted: July 17, 2024
• First Posted: July 22, 2024
• Study Start: October 1, 2024
• Primary Completion: September 1, 2025
• Study Completion: October 1, 2025
• Last Updated: July 22, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

QA (1)