Clinical Trial on Diabetes Expert Patients Programme
EPPD-ICS
Expert Patients Programme Effectiveness on Diabetes Control. A Controlled Clinical Trial
1 other identifier
interventional
500
1 country
3
Brief Summary
The purpose of this study is to determine whether participation in a diabetes expert patients programme course is effective in self-management of a chronic condition such as diabetes, if it reduces Haemoglobin A glycosylated levels, improves patient's quality of life, and prevents the use of some health services.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable diabetes-mellitus-type-2
Started May 2013
Typical duration for not_applicable diabetes-mellitus-type-2
3 active sites
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
May 1, 2013
CompletedFirst Submitted
Initial submission to the registry
July 10, 2013
CompletedFirst Posted
Study publicly available on registry
July 12, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2015
CompletedJuly 23, 2013
July 1, 2013
1.9 years
July 10, 2013
July 21, 2013
Conditions
Outcome Measures
Primary Outcomes (1)
Glycosylated hemoglobin A
Change in glycosylated hemoglobin A percentage level
At baseline, and at 8th and 14th months of follow-up
Secondary Outcomes (2)
Health related quality of life
At baseline, and at 8th and 14th months of follow-up
Health services utilization
12 months before inclusion and 12 months after intervention ends
Study Arms (2)
Diabetes expert patients programme
EXPERIMENTALDiabetes expert patients programme: Participate in a scheduled and standardized expert patients programme course
No intervention
PLACEBO COMPARATORDon't participate in a scheduled and standardized expert patients programme course
Interventions
Nine-weekly informative and educational sessions by a teaching patient who has experience on diabetes
Eligibility Criteria
You may qualify if:
- Diabetes mellitus, Type 2
- Older than 18
You may not qualify if:
- Dementia
- Psychosis
- Home nursing
- Mental disabled people
- Subjects unable to express themselves in Spanish or catalan languages
- Health professionals
- Subjects included simultaneously in other lifestyle counseling or health education programmes
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (3)
Catalan Health Institute, Barcelona District health Authority
Barcelona, Catalonia, 08007, Spain
Catalan Health Institute, Sud metropolitan District health Authority
L'Hospitalet de Llobregat, Catalonia, 08908, Spain
Catalan Health Institute, Catalonia midlands District health Authority
Sant Fruitós de Bages, Catalonia, 08272, Spain
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Carme Boix, RN
Catalan Institute of Health
- STUDY DIRECTOR
Pere Roura-Poch, MD, MPH
Catalan Institute of Health
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 10, 2013
First Posted
July 12, 2013
Study Start
May 1, 2013
Primary Completion
April 1, 2015
Study Completion
December 1, 2015
Last Updated
July 23, 2013
Record last verified: 2013-07