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

This study is enrolling participants by invitation only.

Sponsor:

Information provided by:

Tehran University of Medical Sciences

ClinicalTrials.gov Identifier:

NCT01050803

First received: January 13, 2010

Last updated: March 13, 2011

Last verified: March 2011

History of Changes

Tracking Information
First Received Date ^ICMJE	January 13, 2010
Last Updated Date	March 13, 2011
Start Date ^ICMJE	August 2009
Primary Completion Date	March 2010 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: January 14, 2010)	HbA1c [ Time Frame: within 2 years ] [ Designated as safety issue: No ] BMI [ Time Frame: 2 years ] [ Designated as safety issue: No ]
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT01050803 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: January 14, 2010)	Audit of Diabetes-Dependent Quality of Life (ADDQOL) [ Time Frame: two years ] [ Designated as safety issue: No ]
Original Secondary Outcome Measures ^ICMJE	Same as current
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Effectiveness of the Farsi Diabetes Self-management Education (FDSME) Program for People With Type 2 Diabetes
Official Title ^ICMJE	Effectiveness of the Farsi Diabetes Self-management Education Program for People With Type 2 Diabetes: Randomized Controlled Trial
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
Study Type ^ICMJE	Interventional
Study Phase	Not Provided
Study Design ^ICMJE	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Outcomes Assessor) Primary Purpose: Supportive Care
Condition ^ICMJE	Type 2 Diabetes Mellitus
Intervention ^ICMJE	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.
Study Arm (s)	Experimental: FDSME group 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. Interventions: Behavioral: FDSME group Behavioral: FDSME
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Enrolling by invitation
Enrollment ^ICMJE	280
Estimated Completion Date	April 2011
Primary Completion Date	March 2010 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	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
Gender	Both
Ages	18 Years and older
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	Not Provided

Administrative Information
NCT Number ^ICMJE	NCT01050803
Other Study ID Numbers ^ICMJE	FDSME
Has Data Monitoring Committee	No
Responsible Party	Bagher Larijani, Head, Endocrine and Metabolism Research Center, Tehran University of Medical Sciences
Study Sponsor ^ICMJE	Tehran University of Medical Sciences
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	Tehran University of Medical Sciences
Verification Date	March 2011
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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