Effectiveness of the Farsi Diabetes Self-management Education (FDSME) Program for People With Type 2 Diabetes
FDSME
1 other identifier
interventional
280
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable type-2-diabetes-mellitus
Started Aug 2009
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2009
CompletedFirst Submitted
Initial submission to the registry
January 13, 2010
CompletedFirst Posted
Study publicly available on registry
January 15, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2011
CompletedApril 10, 2024
May 1, 2016
7 months
January 13, 2010
April 9, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
HbA1c
within 2 years
BMI
2 years
Secondary Outcomes (1)
Audit of Diabetes-Dependent Quality of Life (ADDQOL)
two years
Study Arms (2)
FDSME group
EXPERIMENTALIn 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.
Control group
ACTIVE COMPARATORInterventions
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.
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.
Eligibility Criteria
You may qualify if:
- Diagnosed with type 2 diabetes (according to the WHO criteria)
- Older than 18 years
You may not qualify if:
- Pregnancy
- Unable to participate in a group program (for example, housebound or unable to communicate in Farsi)
- Having reduced cognitive ability
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 13, 2010
First Posted
January 15, 2010
Study Start
August 1, 2009
Primary Completion
March 1, 2010
Study Completion
April 1, 2011
Last Updated
April 10, 2024
Record last verified: 2016-05