Ignite Creation Date:
2024-10-26 @ 3:35 PM
Last Modification Date:
2024-10-26 @ 3:35 PM
Study NCT ID:
NCT06513468
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-07-17
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:
None
Organization:
None
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:
No
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:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None