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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01050803
First Posted: January 15, 2010
Last Update Posted: May 17, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Tehran University of Medical Sciences
  Purpose
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.

Condition Intervention
Type 2 Diabetes Mellitus Behavioral: FDSME group Behavioral: FDSME

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: Effectiveness of the Farsi Diabetes Self-management Education Program for People With Type 2 Diabetes: Randomized Controlled Trial

Further study details as provided by Tehran University of Medical Sciences:

Primary Outcome Measures:
  • HbA1c [ Time Frame: within 2 years ]
  • BMI [ Time Frame: 2 years ]

Secondary Outcome Measures:
  • Audit of Diabetes-Dependent Quality of Life (ADDQOL) [ Time Frame: two years ]

Enrollment: 280
Study Start Date: August 2009
Study Completion Date: April 2011
Primary Completion Date: March 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
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.
Active Comparator: Control group 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.

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

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
No Contacts or Locations Provided
  More Information

Responsible Party: Tehran University of Medical Sciences
ClinicalTrials.gov Identifier: NCT01050803     History of Changes
Other Study ID Numbers: FDSME
First Submitted: January 13, 2010
First Posted: January 15, 2010
Last Update Posted: May 17, 2016
Last Verified: May 2016

Keywords provided by Tehran University of Medical Sciences:
Diabetes Mellitus
Intervention studies
Program effectiveness

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases