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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
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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

Resource links provided by NLM:

U.S. FDA Resources

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

Primary Outcome Measures:
  • HbA1c [ Time Frame: within 2 years ] [ Designated as safety issue: No ]
  • BMI [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Audit of Diabetes-Dependent Quality of Life (ADDQOL) [ Time Frame: two years ] [ Designated as safety issue: No ]

Enrollment: 280
Study Start Date: August 2009
Estimated 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.
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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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

No publications provided

Responsible Party: Bagher Larijani, Head, Endocrine and Metabolism Research Center, Tehran University of Medical Sciences
ClinicalTrials.gov Identifier: NCT01050803     History of Changes
Other Study ID Numbers: FDSME
Study First Received: January 13, 2010
Last Updated: March 13, 2011
Health Authority: Iran: Ethics Committee

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

ClinicalTrials.gov processed this record on May 21, 2013