Chronic DiseaseCONCErToNCT02717182
Classification of Patient Therapeutic Education Programs Components : Etude CONCErTo
An observational study of Chronic Disease, run by Central Hospital, Nancy, France at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Chronic Disease
- What is being tested?
- interviews
- How many people
- 100 participants
- Where
- 1 siteFrance
- Study dates
- Apr 2016to Dec 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: patients following a patient education program health care professionals
Who may be able to join
- patients following a patient education program
- professionals involved in a patients education program
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Rat Anne-Christine
Nancy, 54000
Anne - Christine Rat, MD, PhD, (33) 3 83 15 31 96, ac.rat@chru-nancy.fr
About this study
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
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.
Read more
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.
Read the detailed description
This research is an observational study with no intervention. It uses qualitative methods.
The development of the classification consists in 3 phases: a preliminary phase of literature review, an investigation phase and a phase of elaboration of the classification.
Preliminary phase To deepen the questioning of the research, a literature review will be realized on concepts and models as well as on tools and methods used in the published PTE interventions.
Investigation phase
This step uses qualitative methods with 3 types of data collection:
- Semi structured interviews: individual interview will be realized with health care professionals and Therapeutic Patient Education stakeholders (trainers, professional network, decisions makers..). Focus groups will be organized with patients after completion of a therapeutic patient education program.
- In situ observations of the sessions
- Analysis of the documents surrounding the implementation of the interventions: reports, grey literature, applications; the objective is to capture the environment supervising the programs
The investigators plan to include up to 15 programs. However, this number will be adjusted according to the principle of data saturation.
Programs will be selected to ensure variability: the investigators will include hospital based or community based programs, programs led by general practitioners or specialists, with or without patients' implication, recent or experimented programs.
For each program, at least 3 health care professionals and one focus group with patients will be conducted. It will be completed by observation of education sessions.
Other actors (patients' proxies, associations playing a role in the conception or animation of the programs, designers, coordinators, general practitioners, experts of French territorial organization, trainers..;) will complete the data.
The aim of this step is not only to describe the practices but also to interview the experts on the elements they think can impact the results of PTE interventions.
Phase of elaboration of the classification Thematic and content data analyses are scheduled. Concept mapping method will be used to develop the classification.
The classification will be reviewed by experts having not participated to the previous steps.
Validation of the classification :
Applicability and relevance of the classification will be tested with 15 programs in various medical domains.
The classification will then be used in a cohort of patients before and after PTE intervention.
With this classification (or list), recommendations to describe PTE programs will be published.
Eventually, the aim of the recommendations, 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.
- Conditions
- Chronic Disease
- Being tested
- interviews
- Keywords
- self management program, patient education, self care program
- Medical subject headings
- Chronic Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
interviewsOther
interviews
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient-reported elements of patient therapeutic education
Focus groups of patients
Measured: 2 years
Heath care professionals-reported elements of patient therapeutic education
Individual Interviews of health care professionals
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Mar 2016 (estimated)
- Study startApr 2016
- Primary completionDec 2019 (estimated)
- Study completionDec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic DiseaseStudies of the same condition, open and under way.
- More trials run by Central Hospital, Nancy, FranceThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Central Hospital, Nancy, France
- Sponsor type
- University, hospital or other
- Collaborators
- Ministry of Health, France
- Responsible party
- Sponsor
- Investigators
- Anne-Christine Rat, Principal investigator, Nancy Hospital, CIC-EC Inserm CIC 1433; EA 4360 APEMAC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02717182
- Sponsor's protocol ID
- PREPS1439089
- Acronym
- CONCErTo
- Status last verified
- May 2019
- First submitted
- 28 Sep 2015
- Last updated
- 30 May 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02717182
- Acronym / sponsor ID
- CONCErTo / PREPS1439089
- Conditions
- Chronic Disease
- Keywords
- self management program, patient education, self care program
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Central Hospital, Nancy, FranceUniversity, hospital or other
- Collaborators
- Ministry of Health, France
- Study start
- Apr 2016 (actual)
- Primary completion
- Dec 2019 (estimated)
- Study completion
- Dec 2019 (estimated)
- First posted
- 23 Mar 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This research is an observational study with no intervention. It uses qualitative methods.
The development of the classification consists in 3 phases: a preliminary phase of literature review, an investigation phase and a phase of elaboration of the classification.
Preliminary phase To deepen the questioning of the research, a literature review will be realized on concepts and models as well as on tools and methods used in the published PTE interventions.
Investigation phase
This step uses qualitative methods with 3 types of data collection:
- Semi structured interviews: individual interview will be realized with health care professionals and Therapeutic Patient Education stakeholders (trainers, professional network, decisions makers..). Focus groups will be organized with patients after completion of a therapeutic patient education program.
- In situ observations of the sessions
- Analysis of the documents surrounding the implementation of the interventions: reports, grey literature, applications; the objective is to capture the environment supervising the programs
The investigators plan to include up to 15 programs. However, this number will be adjusted according to the principle of data saturation.
Programs will be selected to ensure variability: the investigators will include hospital based or community based programs, programs led by general practitioners or specialists, with or without patients' implication, recent or experimented programs.
For each program, at least 3 health care professionals and one focus group with patients will be conducted. It will be completed by observation of education sessions.
Other actors (patients' proxies, associations playing a role in the conception or animation of the programs, designers, coordinators, general practitioners, experts of French territorial organization, trainers..;) will complete the data.
The aim of this step is not only to describe the practices but also to interview the experts on the elements they think can impact the results of PTE interventions.
Phase of elaboration of the classification Thematic and content data analyses are scheduled. Concept mapping method will be used to develop the classification.
The classification will be reviewed by experts having not participated to the previous steps.
Validation of the classification :
Applicability and relevance of the classification will be tested with 15 programs in various medical domains.
The classification will then be used in a cohort of patients before and after PTE intervention.
With this classification (or list), recommendations to describe PTE programs will be published.
Eventually, the aim of the recommendations, 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.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients following a patient education program health care professionals
Key inclusion criteria (2 listed)
- patients following a patient education program
- professionals involved in a patients education program
Key exclusion criteria (1 listed)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| interviewsinterviews | Other | – |
Primary outcome
Patient-reported elements of patient therapeutic education
Time frame: 2 years
Focus groups of patients
Heath care professionals-reported elements of patient therapeutic education
Time frame: 2 years
Individual Interviews of health care professionals
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 May 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anne-Christine Rat principal investigator
Nancy Hospital, CIC-EC Inserm CIC 1433; EA 4360 APEMAC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Disease, run by Central Hospital, Nancy, France at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 30 May 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Anne-Christine Rat, MD, PhD (+33383153196, ac.rat@chu-nancy.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient-reported elements of patient therapeutic education (time frame: 2 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 May 2019.