Clinical Trial on Diabetes Expert Patients Programme (EPPD-ICS)
Primary Purpose
Diabetes Mellitus, Type 2
Status
Unknown status
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Diabetes expert patients programme
Sponsored by
About this trial
This is an interventional supportive care trial for Diabetes Mellitus, Type 2
Eligibility Criteria
Inclusion Criteria:
- Diabetes mellitus, Type 2
- Older than 18
Exclusion Criteria:
- 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
Sites / Locations
- Catalan Health Institute, Barcelona District health Authority
- Catalan Health Institute, Sud metropolitan District health Authority
- Catalan Health Institute, Catalonia midlands District health AuthorityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Diabetes expert patients programme
No intervention
Arm Description
Diabetes expert patients programme: Participate in a scheduled and standardized expert patients programme course
Don't participate in a scheduled and standardized expert patients programme course
Outcomes
Primary Outcome Measures
Glycosylated hemoglobin A
Change in glycosylated hemoglobin A percentage level
Secondary Outcome Measures
Health related quality of life
Change in scores from Diabetes quality of life questionnaire
Health services utilization
Number of general practitioner consultations, number of outpatient visits, number of emergency department visits, number of hospital admissions and length of stay. All of them diabetes related.
Full Information
NCT ID
NCT01898702
First Posted
July 10, 2013
Last Updated
July 21, 2013
Sponsor
Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina
Collaborators
Catalan Institute of Health
1. Study Identification
Unique Protocol Identification Number
NCT01898702
Brief Title
Clinical Trial on Diabetes Expert Patients Programme
Acronym
EPPD-ICS
Official Title
Expert Patients Programme Effectiveness on Diabetes Control. A Controlled Clinical Trial
Study Type
Interventional
2. Study Status
Record Verification Date
July 2013
Overall Recruitment Status
Unknown status
Study Start Date
May 2013 (undefined)
Primary Completion Date
April 2015 (Anticipated)
Study Completion Date
December 2015 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina
Collaborators
Catalan Institute of Health
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
Detailed Description
The intervention consists in taking part in a diabetes expert patients programme course led by a teaching patient who has experience on chronic disease since he also suffers diabetes. The course is intended for 10 to 15 patients and it is scheduled on 9-weekly sessions (about two hours each session). A nurse supervises the group and observes it without taking part neither on dialogs nor presentations; this nurse helps teaching patient only on logistic needs.
First session main contents are on group operation rules (informed consent expression, confidentiality rules, ...), on reasons and expected results of this kind of self-care support programmes and on general aims and purposes. After explanations, patients are invited to answer a set of validated questionnaires on social, demographic and clinical data (including treatments and comorbidities), diabetes knowledge, self-care and self-assessment and quality of life. In this session body weight, arterial pressure and waist perimeter are also measured and registered. The most recent value (until three months before inclusion) of Haemoglobin A glycosylated will be collected from the lab information system.
The following sessions (from second to ninth) will approach several disease aspects like: what diabetes is, its diagnostic and treatment, acute and chronic complications, food and eating habits, physical exercise and healthy lifestyles, treatment (drugs and insulin) and disease self-control and self-care.
When intervention finishes, a follow-up period starts. At eighth and at 14th month from inclusion, participants will be summoned to provide again answers to questionnaires on knowledge, self-care, and quality of life. At both times, levels of Haemoglobin A glycosylated are also measured.
Patients assigned at control branch are summoned at inclusion to obtain complete baseline data, and also at month 8th and at month 14th. On these three occasions, these subjects answer the same questionnaires (including clinical, morbidity data and lab information) administered to intervention group patients.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Type 2
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
500 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Diabetes expert patients programme
Arm Type
Experimental
Arm Description
Diabetes expert patients programme: Participate in a scheduled and standardized expert patients programme course
Arm Title
No intervention
Arm Type
Placebo Comparator
Arm Description
Don't participate in a scheduled and standardized expert patients programme course
Intervention Type
Behavioral
Intervention Name(s)
Diabetes expert patients programme
Intervention Description
Nine-weekly informative and educational sessions by a teaching patient who has experience on diabetes
Primary Outcome Measure Information:
Title
Glycosylated hemoglobin A
Description
Change in glycosylated hemoglobin A percentage level
Time Frame
At baseline, and at 8th and 14th months of follow-up
Secondary Outcome Measure Information:
Title
Health related quality of life
Description
Change in scores from Diabetes quality of life questionnaire
Time Frame
At baseline, and at 8th and 14th months of follow-up
Title
Health services utilization
Description
Number of general practitioner consultations, number of outpatient visits, number of emergency department visits, number of hospital admissions and length of stay. All of them diabetes related.
Time Frame
12 months before inclusion and 12 months after intervention ends
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Diabetes mellitus, Type 2
Older than 18
Exclusion Criteria:
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Pere Roura-Poch, MD, MPH
Phone
+34.93.693.00.40
Email
proura@chv.cat
First Name & Middle Initial & Last Name or Official Title & Degree
Dolores Álamo-Junquera, MD, MPH
Phone
+34.93.693.00.40
Email
mdalamo.cc.ics@gencat.cat
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Carme Boix, RN
Organizational Affiliation
Catalan Institute of Health
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Pere Roura-Poch, MD, MPH
Organizational Affiliation
Catalan Institute of Health
Official's Role
Study Director
Facility Information:
Facility Name
Catalan Health Institute, Barcelona District health Authority
City
Barcelona
State/Province
Catalonia
ZIP/Postal Code
08007
Country
Spain
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Pere Roura-Poch, MD, MPH
Email
proura@chv.cat
First Name & Middle Initial & Last Name & Degree
Asunción González-Mestre, RN
First Name & Middle Initial & Last Name & Degree
Paloma Amil, RN
First Name & Middle Initial & Last Name & Degree
Claustre Solé, RN
First Name & Middle Initial & Last Name & Degree
Ester Gil, RN
Facility Name
Catalan Health Institute, Sud metropolitan District health Authority
City
L'Hospitalet de Llobregat
State/Province
Catalonia
ZIP/Postal Code
08908
Country
Spain
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Pere Roura-Poch, MD, MPH
Email
proura@chv.cat
First Name & Middle Initial & Last Name & Degree
Rosa M García-Cerdán, RN
Facility Name
Catalan Health Institute, Catalonia midlands District health Authority
City
Sant Fruitós de Bages
State/Province
Catalonia
ZIP/Postal Code
08272
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Pere Roura-Poch, MD, MPH
Phone
+34.93.693.00.40
Email
proura@chv.cat
First Name & Middle Initial & Last Name & Degree
Carme Boix, RN
First Name & Middle Initial & Last Name & Degree
Pere Roura-Poch, MD, MPH
First Name & Middle Initial & Last Name & Degree
Dolores Álamo-Junquera, MD, MPH
First Name & Middle Initial & Last Name & Degree
Núria Sala, RN, MPH
First Name & Middle Initial & Last Name & Degree
Joan P Millet, MD, MPH, PhD
First Name & Middle Initial & Last Name & Degree
Joan Tobías, MD
First Name & Middle Initial & Last Name & Degree
Marta A Palou, RN
First Name & Middle Initial & Last Name & Degree
Montserrat Sallés, RN
12. IPD Sharing Statement
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Clinical Trial on Diabetes Expert Patients Programme
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