COPDRECOORDSNCT06448559
Feedback on the New Profession of Care Manager in Maintenance Pulmonary Rehabilitation Programmes
An observational study of COPD, run by GCS CIPS at 1 site in France.
Trial summary
Pulmonary rehabilitation (PR) is one of the main treatments for COPD, but its benefits are transient. The care manager's mission is to help the patient maintain the long-term benefits of their stay by adopting health-promoting behaviors and anticipating the risks of dropping out. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- COPD
- What is being tested?
- Semi-directive interview
- How many people
- 16 participants
- Where
- 1 siteFrance
- Study dates
- 19 Aug 2024to 28 Mar 2025
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: COPD patients, informal caregivers and care-managers participating in a M-PRP
Who may be able to join
- For COPD patients
- Patients who have joined a long-term and remote M-PRP.
- Patients followed or having been followed for more than 6 months by a care manager
- Patients who have attended at least 30% of follow-up interviews
- For Informal Caregivers
- Informal caregivers designated by patients who participated in M-PRP
Show all 12Show fewer
- A person who meets the definition of a carer under article L.113-1-3 of the law of 28/12/2015 relating to the adaptation of society to ageing (www.legifrance.gouv.fr/loda/article_lc/JORFARTI000031701024/) i.e.: 'The following are considered to be close carers of an elderly person: their spouse, the partner with whom they have entered into a civil solidarity pact or their cohabitee, a parent or an ally, defined as family carers, or a person living with them or maintaining close and stable ties with them, who helps them, on a regular and frequent basis, on a non-professional basis, to carry out all or part of the acts or activities of daily life.'
- Person meeting the criteria of carer for more than 6 months
- For Care-managers
- Health professionals who have carried out the mission of care-manager within the framework of a M-PRP
- Health professional who is or has been a care-manager for more than 6 months
- Care-manager who follows or has followed more than 10 patients
Who cannot join
- For COPD patients
- Protected adults, vulnerable persons
- Patients who completed their M-PRP more than 4 months ago.
- For Informal Caregivers
- Minors, protected adults, vulnerable persons
- Helped patients who have completed their M-PRP for more than 4 months.
- For Care-managers
- No exclusion criteria
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Feedback From Patients, Informal Caregivers and Healthcare Professionals on the New Profession of Care Manager in Maintenance Pulmonary Rehabilitation Programmes: a Qualitative Study
Pulmonary rehabilitation (PR) is one of the main treatments for COPD, but its benefits are transient. The care manager's mission is to help the patient maintain the long-term benefits of their stay by adopting health-promoting behaviors and anticipating the risks of dropping out. To do this, it has IT tools allowing it to monitor the patient remotely. He/She remains in contact with the patient and discussion times are regularly scheduled; It also relies on the multidisciplinary team of the PR center to guide the patient when needs are identified.
As the experiments have not yet been completed, the effectiveness and efficiency data (cost-economic ratio) are not yet known. However, beyond these highly anticipated quantitative results, these experiments do not plan to analyze this new mode of support on a qualitative side. Even if they prove favorable, the quantitative results will in no way predict the success of the deployment of this type of support on a large scale. Taking into account the opinions of users, but also the difficulties encountered or potential points of improvement are all important data to take into account in order to successfully implement this new profession outside the framework and controlled context of the experimentation. Consequently, we aim to conduct a qualitative study with feedback from patients participating in ongoing healthcare professional experiments, on the new profession of care manager. We also want to interview their informal caregivers and health professionals practicing this new profession.
Read the detailed description
Pulmonary rehabilitation (PR) is one of the main treatments for COPD, but its benefits are transient. Indeed, patients generally return to their initial state of health within 6 months to 1 year after the PR stay. To increase long-term effectiveness, several recent studies have experimented with maintenance PR programmes (M-PRPs), orchestrated by a care manager. The care manager's mission is to help the patient maintain the long-term benefits of their stay by adopting health-promoting behaviors and anticipating the risks of dropping out. To do this, it has IT tools allowing it to monitor the patient remotely, such as a digital monitoring solution (educational sheets, shared calendar, videoconferencing tool, etc.) and connected objects (scales, blood pressure monitor, etc.). He/She remains in contact with the patient and discussion times are regularly scheduled (once or several times per month). It also relies on the multidisciplinary team of the PR center to guide the patient when needs are identified.
This mode of support based on the emergence of a new profession seems promising because it responds to a real need shared by patients, namely the need to be supported beyond the temporary bubble of the PR stay, while relying on telecommunications tools in order to be part of an economically reasoned approach. As the experiments have not yet been completed, the effectiveness and efficiency data (cost-economic ratio) are not yet known. However, beyond these highly anticipated quantitative results, these experiments do not plan to analyze this new mode of support on a qualitative side. However, even if they prove favorable, the quantitative results will in no way predict the success of the deployment of this type of support on a large scale. Taking into account the opinions of users, but also the difficulties encountered or potential points of improvement are all important data to take into account in order to successfully implement this new profession outside the framework and controlled context of the experimentation. Thus, we wish to conduct a qualitative study with feedback from patients participating in ongoing healthcare professional experiments, on the new profession of care manager. We also want to interview their informal caregivers and health professionals practicing this new profession.
- Conditions
- COPD
- Being tested
- Semi-directive interview
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Semi-directive interviewOther
Semi-directive interviews are individual interviews used in a qualitative approach to collect information in order to perform a thematic analysis
| Study group | Role | What they receive |
|---|---|---|
| Patients with Chronic obstructive pulmonary disease (COPD) | Patients who have joined a long-term and remote Maintenance Pulmonary Rehabilitation Programmes (M-PRP) No intervention Semi-directive interview Receives: Other: Semi-directive interview | |
| Informal caregivers | Informal caregivers designated by patients who participated in M-PRP No intervention Semi-directive interview Receives: Other: Semi-directive interview | |
| Care-managers | Health professionals who have carried out the mission of monitoring coordinator (care-manager) within the framework of a M-PRP No intervention Semi-directive interview Receives: Other: Semi-directive interview |
What is being measured
The primary outcome is the main question the study is designed to answer.
Typology and categorization of definition and perception of the profession of care manager
collected through interviews with each group
Measured: During M-PRP or just after completion
Typology and categorization of technical aspect / modalities of the profession of care-manager
collected through interviews with each group
Measured: During M-PRP or just after completion
Typology and categorization of areas for improvement concerning the profession of care manager
collected through interviews with each group
Measured: During M-PRP or just after completion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2024
- Study start19 Aug 2024
- Primary completion28 Mar 2025
- Study completion28 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COPDStudies of the same condition, open and under way.
- 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
- Prospective
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- GCS CIPS
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nelly HERAUD, PhD, Study director, CLARIANE
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06448559
- Sponsor's protocol ID
- RECOORDS
- Acronym
- RECOORDS
- Status last verified
- Apr 2025
- First submitted
- 4 Jun 2024
- Last updated
- 6 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feedback From Patients, Informal Caregivers and Healthcare Professionals on the New Profession of Care Manager in Maintenance Pulmonary Rehabilitation Programmes: a Qualitative Study
- ClinicalTrials.gov ID
- NCT06448559
- Acronym / sponsor ID
- RECOORDS / RECOORDS
- Conditions
- COPD
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- GCS CIPSUniversity, hospital or other
- Study start
- 19 Aug 2024 (actual)
- Primary completion
- 28 Mar 2025 (actual)
- Study completion
- 28 Mar 2025 (actual)
- First posted
- 7 Jun 2024 (actual)
- 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.
Pulmonary rehabilitation (PR) is one of the main treatments for COPD, but its benefits are transient. The care manager's mission is to help the patient maintain the long-term benefits of their stay by adopting health-promoting behaviors and anticipating the risks of dropping out. To do this, it has IT tools allowing it to monitor the patient remotely. He/She remains in contact with the patient and discussion times are regularly scheduled; It also relies on the multidisciplinary team of the PR center to guide the patient when needs are identified.
As the experiments have not yet been completed, the effectiveness and efficiency data (cost-economic ratio) are not yet known. However, beyond these highly anticipated quantitative results, these experiments do not plan to analyze this new mode of support on a qualitative side. Even if they prove favorable, the quantitative results will in no way predict the success of the deployment of this type of support on a large scale. Taking into account the opinions of users, but also the difficulties encountered or potential points of improvement are all important data to take into account in order to successfully implement this new profession outside the framework and controlled context of the experimentation. Consequently, we aim to conduct a qualitative study with feedback from patients participating in ongoing healthcare professional experiments, on the new profession of care manager. We also want to interview their informal caregivers and health professionals practicing this new profession.
Detailed description
Pulmonary rehabilitation (PR) is one of the main treatments for COPD, but its benefits are transient. Indeed, patients generally return to their initial state of health within 6 months to 1 year after the PR stay. To increase long-term effectiveness, several recent studies have experimented with maintenance PR programmes (M-PRPs), orchestrated by a care manager. The care manager's mission is to help the patient maintain the long-term benefits of their stay by adopting health-promoting behaviors and anticipating the risks of dropping out. To do this, it has IT tools allowing it to monitor the patient remotely, such as a digital monitoring solution (educational sheets, shared calendar, videoconferencing tool, etc.) and connected objects (scales, blood pressure monitor, etc.). He/She remains in contact with the patient and discussion times are regularly scheduled (once or several times per month). It also relies on the multidisciplinary team of the PR center to guide the patient when needs are identified.
This mode of support based on the emergence of a new profession seems promising because it responds to a real need shared by patients, namely the need to be supported beyond the temporary bubble of the PR stay, while relying on telecommunications tools in order to be part of an economically reasoned approach. As the experiments have not yet been completed, the effectiveness and efficiency data (cost-economic ratio) are not yet known. However, beyond these highly anticipated quantitative results, these experiments do not plan to analyze this new mode of support on a qualitative side. However, even if they prove favorable, the quantitative results will in no way predict the success of the deployment of this type of support on a large scale. Taking into account the opinions of users, but also the difficulties encountered or potential points of improvement are all important data to take into account in order to successfully implement this new profession outside the framework and controlled context of the experimentation. Thus, we wish to conduct a qualitative study with feedback from patients participating in ongoing healthcare professional experiments, on the new profession of care manager. We also want to interview their informal caregivers and health professionals practicing this new profession.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Patients with Chronic obstructive pulmonary disease (COPD) | – | Other: Semi-directive interviewPatients who have joined a long-term and remote Maintenance Pulmonary Rehabilitation Programmes (M-PRP) No intervention Semi-directive interview |
| Informal caregivers | – | Other: Semi-directive interviewInformal caregivers designated by patients who participated in M-PRP No intervention Semi-directive interview |
| Care-managers | – | Other: Semi-directive interviewHealth professionals who have carried out the mission of monitoring coordinator (care-manager) within the framework of a M-PRP No intervention Semi-directive interview |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- COPD patients, informal caregivers and care-managers participating in a M-PRP
Key inclusion criteria (12 listed)
- For COPD patients
- For Informal Caregivers
- For Care-managers
Key exclusion criteria (8 listed)
- For COPD patients
- For Informal Caregivers
- For Care-managers
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 |
|---|---|---|
| Semi-directive interviewSemi-directive interviews are individual interviews used in a qualitative approach to collect information in order to perform a thematic analysis | Other | Care-managers, Informal caregivers, Patients with Chronic obstructive pulmonary disease (COPD) |
Primary outcome
Typology and categorization of definition and perception of the profession of care manager
Time frame: During M-PRP or just after completion
collected through interviews with each group
Typology and categorization of technical aspect / modalities of the profession of care-manager
Time frame: During M-PRP or just after completion
collected through interviews with each group
Typology and categorization of areas for improvement concerning the profession of care manager
Time frame: During M-PRP or just after completion
collected through interviews with each group
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2025.
- Individual participant dataSharing planned: Undecided
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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.
Nelly HERAUD, PhD study director
CLARIANE
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 COPD, run by GCS CIPS 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 12 inclusion and 8 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: finished, as of the sponsor's last update on 6 Apr 2025. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Typology and categorization of definition and perception of the profession of care manager (time frame: During M-PRP or just after completion). The study lists 3 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 6 Apr 2025.