Ignite Creation Date:
2025-12-24 @ 7:44 PM
Ignite Modification Date:
2025-12-25 @ 5:22 PM
Study NCT ID:
NCT01050803
Status:
COMPLETED
Last Update Posted:
2024-04-10
First Post:
2010-01-13
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effectiveness of the Farsi Diabetes Self-management Education (FDSME) Program for People With Type 2 Diabetes
Sponsor:
Tehran University of Medical Sciences
Organization:
Study Overview
Official Title:
Effectiveness of the Farsi Diabetes Self-management Education Program for People With Type 2 Diabetes: Randomized Controlled Trial
Status:
COMPLETED
Status Verified Date:
2016-05
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:
FDSME
Brief Summary:
To evaluate the effectiveness of the Farsi diabetes self-management education program on psychosocial, lifestyle, and clinical measures in people with newly diagnosed people with type 2 diabetes and those with already-diagnosed type two diabetes who had received little self-management education. The development of the program was guided by an innovative process of intervention planning: Intervention Mapping.
Detailed Description:
For designing the management program, we will use Intervention Mapping (IM) framework for systematically developing the theory and evidence based program.
Based on IM approach, this study will have seven phases:
Step 1: needs assessment (Development the problem analysis: health, quality of life, behavior, environment).
Step 2: We will develop proximal program objectives with a multidisciplinary expert panel of participants.
Step 3: After identification of the proximal program objectives, the next step will be to select theoretical methods and practical strategies based on evidence for alternative methods.
Step 4: The forth step of the program development will comprise of composing program materials and pre-testing these materials with a sample of patients at a diabetic outpatient clinic.
Step 5: By involving the future program facilitators (health care workers at outpatient clinics) a linkage system will be foreseen.
Step 6: planning for evaluation Step 7: Randomized Clinical Trial
Based on IM approach, this study will have seven phases:
Step 1: needs assessment (Development the problem analysis: health, quality of life, behavior, environment).
Step 2: We will develop proximal program objectives with a multidisciplinary expert panel of participants.
Step 3: After identification of the proximal program objectives, the next step will be to select theoretical methods and practical strategies based on evidence for alternative methods.
Step 4: The forth step of the program development will comprise of composing program materials and pre-testing these materials with a sample of patients at a diabetic outpatient clinic.
Step 5: By involving the future program facilitators (health care workers at outpatient clinics) a linkage system will be foreseen.
Step 6: planning for evaluation Step 7: Randomized Clinical Trial
Study Oversight
Has Oversight DMC:
False
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?: