NCT01050803

Effectiveness of the Farsi Diabetes Self-management Education (FDSME) Program for People With Type 2 Diabetes

Effectiveness of the Farsi Diabetes Self-management Education Program for People With Type 2 Diabetes: Randomized Controlled Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 280 (actual)
• Sponsor: Tehran University of Medical Sciences · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Conditions

• Type 2 Diabetes Mellitus

Interventions

Type	Name	Description
BEHAVIORAL	FDSME group	In the intervention group, diabetes education sessions which are designed based on the "Intervention Mapping" will be interactive and reflection in between sessions will be encouraged. Group-based problem-solving exercises will be used during the sessions. Participants receive feedback from peers and healthcare professionals at the following sessions.
BEHAVIORAL	FDSME	In the intervention group, sessions which are designed based on the "Intervention Mapping" will be interactive and reflection in between sessions will be encouraged. Group-based problem-solving exercises will be used during the sessions. Participants receive feedback from peers and healthcare professionals at the following sessions.

Timeline

• Start date: 2009-08-01
• Primary completion: 2010-03-01
• Completion: 2011-04-01
• First posted: 2010-01-15
• Last updated: 2024-04-10