Clinical trial 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.
Official title: 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.
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Diabetes Mellitus, Type 2
Keywords: Diabetes self management
DESMOND
effect of diabetes self management on glycemic control
Lead sponsor: Primary Health Care Corporation, Qatar
Sponsor class: OTHER_GOV
First posted: 2024-07-22
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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
Primary purpose: OTHER

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Blood HbA1C %
timeFrame: before starting the diabetes standard care , after 3, and 6 months of follow up for both arms
measure: The Diabetes self-management score using the (DSMQ)
timeFrame: before starting the diabetes standard care , after 3, and 6 months of follow up for both arms
Secondary outcomes:
Other outcomes:
Locations:
city: Doha
country: Qatar
facility: Primary Health Care Corporation
Study officials:
References: