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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03192228
Recruitment Status : Completed
First Posted : June 20, 2017
Last Update Posted : June 20, 2017
Sponsor:
Information provided by (Responsible Party):
Joe Elie Salem, Groupe Hospitalier Pitie-Salpetriere

Brief Summary:

Therapeutic education programs allows in diabetic patients to promote self-care and better perception of the disease

Our 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
Diabetes Mellitus, Type 2 Patient Education as Topic Other: Treatment adequacy score

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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 : July 2011
Actual Primary Completion Date : May 2012
Actual Study Completion Date : September 2012

Resource links provided by the National Library of Medicine



Intervention Details:
  • Other: Treatment adequacy score
    Evaluation of the program rate of success rate by a score evaluating the different criteria that the patient was supposed to modify following the therapeutic education program: practice of a physical activity, reduction of the amount of fat in Diet, practice of self-monitoring blood sugar as a motivational tool and decreased distress related to diabetes


Primary Outcome Measures :
  1. Success rate of the therapeutic education program [ Time Frame: 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 [ Time Frame: 6 month ]
    The rate of success of the program defined by a 50% improvement in the treatment adequacy score evaluated at 6 month



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

This initial education program is intended for patients with type 2 diabetes:

  • who have recently been diagnosed with type 2 diabetes
  • or who have an HbA1c greater than 7% and unability to lower their blood glucose levels despite an optimal management by general practitioner but do not yet require insulin treatment
Criteria

Inclusion Criteria:

  • All Type 2 diabetic patients who participate in the multidisciplinary program
  • Signature information form and consent by the patient

Exclusion Criteria:

  • None

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Responsible Party: Joe Elie Salem, MD, PhD, Groupe Hospitalier Pitie-Salpetriere
ClinicalTrials.gov Identifier: NCT03192228     History of Changes
Other Study ID Numbers: CIC1421-10-15
First Posted: June 20, 2017    Key Record Dates
Last Update Posted: June 20, 2017
Last Verified: June 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Joe Elie Salem, Groupe Hospitalier Pitie-Salpetriere:
Diabetes Mellitus, Type 2 +
Patient Education

Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases