- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02159417
Therapeutic Education of the Patients Diabetics Imprisoned at the Paris Jail (EPRIDIA)
Feasibility of the Therapeutic Education of the Patients Diabetics Imprisoned at the Paris Jail "La Santé" (Maison d'arrêt Paris La Santé)"
A lot of data show that therapeutic education is beneficial for diabetic patients. In the French jails, there are very few programs of therapeutic education while this population is usually precarious with no access at care sector before the jail.
The purpose of this study is to determinate if the therapeutic education of the diabetic patients is possible in the Paris jail "La Santé".
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
The Paris jail "La Santé" welcomes 600 men who stay 5 month on average. Each year, there are between 30 to 40 diabetic patients. In the jail there's a sanitary unit who is a unit of internal medicine of Cochin hospital. This unit includes nurses, pharmacists and medical doctors.
We propose to include in this study all diabetic patients (type 1 and 2) with the realization of a consultation of educational diagnosis, followed by the participation for every patient to 4 educational collective workshops therapeutic (knowledge of the disease, food, physical Activity and care of feet, the therapeutics)
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Paris, France, 75014
- Hopital Cochin
-
Paris, France, 75014
- Maison d'Arrêt Paris La Santé (MAPLS)
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Male patient detained in the MAPLS of more than 18 years
- Patient prisoner in the MAPLS for more than 15 days
- Patient follow-up for a diabetes of type 1 or type 2
- Patient informed about the study and not having opposed to this one
- Patient taken out of the disciplinary district which had previously been included for this motive
Exclusion Criteria:
- Patient considered incapable by the investigator to follow an ETP program
- Patient having a bad understanding of the spoken French language
- Patient whose duration of confinement known about the MAPLS is strictly lower than 1 month in the inclusion during the year 2013/2014
- Patient prisoner in the district of isolation
- Patient prisoner in the disciplinary district in the inclusion
- Patient prohibition to communicate with another prisoner already registered on the session to come
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Therapeutic Education
Intensive training individual or collective teaching
|
Realization of a consultation of educational diagnosis, followed by the participation for every patient to 4 educational collective workshops therapeutic:
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
The feasibility of the application of the action ETP in the MAPLS
Time Frame: 3 months
|
Rate of participation to at least two therapeutic workshops
|
3 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Estimation of the satisfaction of the prisoners and the nursing after participation of educational therapeutic workshops
Time Frame: 3 months
|
To fill in an auto-questionnaire by means of the scale of Likert in 5 points
|
3 months
|
|
biomedical parameters: HbA1c and IMC
Time Frame: 3 months
|
Clinical evolution of the patients
|
3 months
|
|
The number of hours all in all, for all the activities ETP and by categories of tasks
Time Frame: 3 months
|
To evaluate of the mobilized resources
|
3 months
|
|
The satisfaction of the staffs as for the implementation and the realization of the experiment
Time Frame: 3 months
|
to evaluate of the mobilized resources
|
3 months
|
Collaborators and Investigators
Collaborators
Investigators
- Study Director: Benjamin SILBERMANN, MD, PhD, Assistance Publique - Hopitaux de Paris
- Study Director: Laura HARCOUET, Pharm D, Assistance Publique - Hopitaux de Paris
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 2013-A00704-41
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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