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

April 9, 2024 updated by: Tehran University of Medical Sciences

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Interventional

Enrollment (Actual)

280

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
HbA1c
Time Frame: within 2 years
within 2 years
BMI
Time Frame: 2 years
2 years

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tehran University of Medical Sciences

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2009

Primary Completion (Actual)

March 1, 2010

Study Completion (Actual)

April 1, 2011

Study Registration Dates

First Submitted

January 13, 2010

First Submitted That Met QC Criteria

January 14, 2010

First Posted (Estimated)

January 15, 2010

Study Record Updates

Last Update Posted (Actual)

April 10, 2024

Last Update Submitted That Met QC Criteria

April 9, 2024

Last Verified

May 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FDSME

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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