Impact of a Multidisciplinary Therapeutic Education Program Being Set up for Patients With Type 2 Diabetes Mellitus

• Sponsor: Groupe Hospitalier Pitie-Salpetriere (Other)
• Overall Status: Completed
• CT.gov ID: NCT03192228
• Collaborator: (none)
• Enrollment: 120
• Actual Duration (Months): 14.1

Study Details

Study Description

Brief Summary

Therapeutic education programs allows in diabetic patients to promote self-care and better perception of the disease The multidisciplinary program of therapeutic education regroups in one day: individual interview, nutritional workshop, self-monitoring blood glucose workshop, physical activity and glycemic objectives workshop.

At the end of the program, individual and personalized goals are given to the patient.

This study aims to evaluate this program success rates and the psychological, anamnesis, and sociological factors linked to success.

Condition or Disease	Intervention/Treatment	Phase
Diabetes Mellitus, Type 2; Patient Education as Topic	Other: Treatment adequacy score

Study Design

• Study Type: Observational
• Actual Enrollment: 120 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Evaluation of a Multidisciplinary Program of Therapeutic Education in Type 2 Diabetes Mellitus Diabetes in Order to Fix Individualized Objectives
• Actual Study Start Date: Jul 1, 2011
• Actual Primary Completion Date: May 1, 2012
• Actual Study Completion Date: Sep 1, 2012

Outcome Measures

Primary Outcome Measures

1. Success rate of the therapeutic education program [one month]

   The rate of success of the program defined by a 50% improvement in the treatment adequacy score evaluated at 1 month

Secondary Outcome Measures

1. Long term success rate of the therapeutic education program [6 month]

   The rate of success of the program defined by a 50% improvement in the treatment adequacy score evaluated at 6 month

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 70 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• All Type 2 diabetic patients who participate in the multidisciplinary program

• Signature information form and consent by the patient

Exclusion Criteria:

• None

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Groupe Hospitalier Pitie-Salpetriere

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Joe Elie Salem, MD, PhD, Groupe Hospitalier Pitie-Salpetriere
• ClinicalTrials.gov Identifier: NCT03192228
• Other Study ID Numbers: CIC1421-10-15
• First Posted: Jun 20, 2017
• Last Update Posted: Oct 31, 2019
• Last Verified: Oct 1, 2019

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Joe Elie Salem, MD, PhD, Groupe Hospitalier Pitie-Salpetriere: Diabetes Mellitus, Type 2 +; Patient Education
• Additional relevant MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2

Study Results

No Results Posted as of Oct 31, 2019