NCT02717182

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.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Apr 2016

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 28, 2015

Completed
6 months until next milestone

First Posted

Study publicly available on registry

March 23, 2016

Completed
9 days until next milestone

Study Start

First participant enrolled

April 1, 2016

Completed
3.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2019

Completed
Last Updated

May 30, 2019

Status Verified

May 1, 2019

Enrollment Period

3.7 years

First QC Date

September 28, 2015

Last Update Submit

May 29, 2019

Conditions

Keywords

self management programpatient educationself care program

Outcome Measures

Primary Outcomes (2)

  • Patient-reported elements of patient therapeutic education

    Focus groups of patients

    2 years

  • Heath care professionals-reported elements of patient therapeutic education

    Individual Interviews of health care professionals

    2 years

Interventions

interviews

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

patients following a patient education program health care professionals

You may qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rat Anne-Christine

Nancy, 54000, France

RECRUITING

MeSH Terms

Conditions

Chronic Disease

Interventions

Interviews as Topic

Condition Hierarchy (Ancestors)

Disease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Data CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Study Officials

  • Anne-Christine Rat

    Nancy Hospital, CIC-EC Inserm CIC 1433; EA 4360 APEMAC

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Anne-Christine Rat, MD, PhD

CONTACT

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 28, 2015

First Posted

March 23, 2016

Study Start

April 1, 2016

Primary Completion

December 1, 2019

Study Completion

December 1, 2019

Last Updated

May 30, 2019

Record last verified: 2019-05

Locations