NCT02159417

Brief Summary

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".

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
22

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2013

Geographic Reach
1 country

2 active sites

Status
completed

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

November 1, 2013

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

June 5, 2014

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 9, 2014

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2014

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2015

Completed
Last Updated

November 20, 2025

Status Verified

September 1, 2025

Enrollment Period

11 months

First QC Date

June 5, 2014

Last Update Submit

November 17, 2025

Conditions

Keywords

Evolution of the sport, HbA1C, IMC

Outcome Measures

Primary Outcomes (1)

  • The feasibility of the application of the action ETP in the MAPLS

    Rate of participation to at least two therapeutic workshops

    3 months

Secondary Outcomes (4)

  • Estimation of the satisfaction of the prisoners and the nursing after participation of educational therapeutic workshops

    3 months

  • biomedical parameters: HbA1c and IMC

    3 months

  • The number of hours all in all, for all the activities ETP and by categories of tasks

    3 months

  • The satisfaction of the staffs as for the implementation and the realization of the experiment

    3 months

Study Arms (1)

Therapeutic Education

EXPERIMENTAL

Intensive training individual or collective teaching

Other: Therapeutic Education

Interventions

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

Also known as: Intensive training individual and collective teaching
Therapeutic Education

Eligibility Criteria

Age18 Years+
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Patient considered incapable by the investigator to follow an ETP program
  • Patient having a bad understanding of the spoken French language
  • Patient prisoner in the district of isolation
  • Patient prohibition to communicate with another prisoner already registered on the session to come

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Hôpital COCHIN

Paris, 75014, France

Location

Maison d'Arrêt Paris La Santé (MAPLS)

Paris, 75014, France

Location

Study Officials

  • Benjamin SILBERMANN, MD, PhD

    Assistance Publique - Hôpitaux de Paris

    STUDY DIRECTOR
  • Laura HARCOUET, Pharm D

    Assistance Publique - Hôpitaux de Paris

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 5, 2014

First Posted

June 9, 2014

Study Start

November 1, 2013

Primary Completion

October 1, 2014

Study Completion

February 1, 2015

Last Updated

November 20, 2025

Record last verified: 2025-09

Locations