Ignite Creation Date:
2025-12-24 @ 5:48 PM
Ignite Modification Date:
2026-01-03 @ 9:15 PM
Study NCT ID:
NCT06513468
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-07-22
First Post:
2024-07-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief 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.
Sponsor:
Primary Health Care Corporation, Qatar
Organization:
Study Overview
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.
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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.
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 Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: