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

Study Overview
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Brief Summary
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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
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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

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

Conditions
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Type 2 Diabetes Mellitus

Intervention / Treatment
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* Behavioral: FDSME group
* Behavioral: FDSME


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Diagnosed with type 2 diabetes (according to the WHO criteria) Older than 18 years Exclusion Criteria: Pregnancy Unable to participate in a group program (for example, housebound or unable to communicate in Farsi) Having reduced cognitive ability

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: FDSME group<br>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<br>* 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.<br>|
| Active Comparator: Control group<br> | Behavioral: FDSME<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| HbA1c |  | within 2 years | 
| BMI |  | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Audit of Diabetes-Dependent Quality of Life (ADDQOL) |  | two years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Diabetes Mellitus, Intervention studies, Program effectiveness