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Classification of Patient Therapeutic Education Programs Components : Etude CONCErTo (CONCErTo)

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT02717182
Recruitment Status : Recruiting
First Posted : March 23, 2016
Last Update Posted : May 30, 2019
Ministry of Health, France
Information provided by (Responsible Party):
Central Hospital, Nancy, France

Brief Summary:

Interest in patient therapeutic education (PTE) is increasing: in France PTE was included within the 2009 "Hospital, Patient, Health and Territory" law as an essential component of the patient healthcare pathway.

PTE is a complex intervention: its delivery is variable and may vary according to its content, functioning, providers, targeted patients, environment and even its objectives. These differences impact the expected results and make difficult the evaluation of PTE interventions. To overcome this difficulty, it is essential to describe precisely the intervention, the processes and the implementation of PTE that are usually not known. PTE interventions need today a global understanding of their mechanisms constituting their complexity.

CONCErTo study aims at developing a classification of the different elements composing a PTE intervention that can impact their results and can ensure their continued existence.

Mechanisms implemented during PTE interventions will be analyzed by a qualitative research. The investigators wish to identify organizational, pedagogical, psychosocial, medical or contextual elements that can impact the results, the patients' participation and the continuity of the program.

The perspective of this research is to improve the understanding of PTE by providing thorough description of the interventions. This work will help stakeholders to better interpret the results of their interventions, to improve the transferability, the implementation and finally to determine which are the elements able to improve patients' health status.

Condition or disease Intervention/treatment
Chronic Disease Other: interviews

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Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Other
Time Perspective: Cross-Sectional
Official Title: Development of a Classification of the Components of Patient Therapeutic Education Interventions That Can Impact Their Results and Can Ensure Their Continued Existence CONCErTo Study
Actual Study Start Date : April 2016
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine

Intervention Details:
  • Other: interviews

Primary Outcome Measures :
  1. Patient-reported elements of patient therapeutic education [ Time Frame: 2 years ]
    Focus groups of patients

  2. Heath care professionals-reported elements of patient therapeutic education [ Time Frame: 2 years ]
    Individual Interviews of health care professionals

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
patients following a patient education program health care professionals

Inclusion Criteria:

  • patients following a patient education program
  • professionals involved in a patients education program

Exclusion Criteria:


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02717182

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Contact: Anne-Christine Rat, MD, PhD +33383153196

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Rat Anne-Christine Recruiting
Nancy, France, 54000
Contact: Anne - Christine Rat, MD, PhD    (33) 3 83 15 31 96   
Sponsors and Collaborators
Central Hospital, Nancy, France
Ministry of Health, France
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Principal Investigator: Anne-Christine Rat Nancy Hospital, CIC-EC Inserm CIC 1433; EA 4360 APEMAC
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Responsible Party: Central Hospital, Nancy, France Identifier: NCT02717182    
Other Study ID Numbers: PREPS1439089
First Posted: March 23, 2016    Key Record Dates
Last Update Posted: May 30, 2019
Last Verified: May 2019
Keywords provided by Central Hospital, Nancy, France:
self management program
patient education
self care program
Additional relevant MeSH terms:
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Chronic Disease
Disease Attributes
Pathologic Processes