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

Primary Purpose

Type 2 Diabetes Mellitus

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
FDSME group
FDSME
Sponsored by
Tehran University of Medical Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Type 2 Diabetes Mellitus focused on measuring Diabetes Mellitus, Intervention studies, Program effectiveness

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    FDSME group

    Control group

    Arm Description

    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.

    Outcomes

    Primary Outcome Measures

    HbA1c
    BMI

    Secondary Outcome Measures

    Audit of Diabetes-Dependent Quality of Life (ADDQOL)

    Full Information

    First Posted
    January 13, 2010
    Last Updated
    May 16, 2016
    Sponsor
    Tehran University of Medical Sciences
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    1. Study Identification

    Unique Protocol Identification Number
    NCT01050803
    Brief Title
    Effectiveness of the Farsi Diabetes Self-management Education (FDSME) Program for People With Type 2 Diabetes
    Acronym
    FDSME
    Official Title
    Effectiveness of the Farsi Diabetes Self-management Education Program for People With Type 2 Diabetes: Randomized Controlled Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    May 2016
    Overall Recruitment Status
    Completed
    Study Start Date
    August 2009 (undefined)
    Primary Completion Date
    March 2010 (Actual)
    Study Completion Date
    April 2011 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Tehran University of Medical Sciences

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    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

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Type 2 Diabetes Mellitus
    Keywords
    Diabetes Mellitus, Intervention studies, Program effectiveness

    7. Study Design

    Primary Purpose
    Supportive Care
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    280 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    FDSME group
    Arm Type
    Experimental
    Arm Description
    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.
    Arm Title
    Control group
    Arm Type
    Active Comparator
    Intervention Type
    Behavioral
    Intervention Name(s)
    FDSME group
    Intervention Description
    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.
    Intervention Type
    Behavioral
    Intervention Name(s)
    FDSME
    Intervention Description
    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.
    Primary Outcome Measure Information:
    Title
    HbA1c
    Time Frame
    within 2 years
    Title
    BMI
    Time Frame
    2 years
    Secondary Outcome Measure Information:
    Title
    Audit of Diabetes-Dependent Quality of Life (ADDQOL)
    Time Frame
    two years

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility 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

    12. IPD Sharing Statement

    Learn more about this trial

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

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