An interventional study of FDSME group and FDSME in Type 2 Diabetes Mellitus, sponsored by Tehran University of Medical Sciences. Completed. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-04-10.
Sponsored by Tehran University of Medical Sciences · Not applicable, Interventional, and Supportive care
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.
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
10,925 studies on the registry are indexed under Diabetes Mellitus; 1,318 are open to participants now.
This study's enrollment of 280 is above the median of 80 across 8,367 interventional studies indexed under Diabetes Mellitus.
Browse Diabetes Mellitus studies →Tehran University of Medical Sciences is the lead sponsor of 227 studies on the registry; 12 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
In the FDSME group, sessions will be held 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 group
Behavioral: FDSME
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.
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.
HbA1c
Time frame: within 2 years
BMI
Time frame: 2 years
Audit of Diabetes-Dependent Quality of Life (ADDQOL)
Time frame: two years
No study locations are listed for this record.
This study is completed, as verified in May 2016. You cannot join it, but the record below documents what was studied.
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Tehran University of Medical Sciences