Feedback on the New Profession of Care Manager in Maintenance Pulmonary Rehabilitation Programmes (RECOORDS)

April 3, 2025 updated by: GCS CIPS

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

16

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Lodeve, France
        • Clinique Souffle La Vallonie

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

COPD patients, informal caregivers and care-managers participating in a M-PRP

Description

Inclusion Criteria:

  1. 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
  2. For Informal Caregivers

    • Informal caregivers designated by patients who participated in M-PRP
    • 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
  3. 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

Exclusion Criteria:

  1. For COPD patients

    • Protected adults, vulnerable persons
    • Patients who completed their M-PRP more than 4 months ago.
  2. For Informal Caregivers

    • Minors, protected adults, vulnerable persons
    • Helped patients who have completed their M-PRP for more than 4 months.
  3. For Care-managers

    • No exclusion criteria

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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
Semi-directive interviews are individual interviews used in a qualitative approach to collect information in order to perform a thematic analysis
Informal caregivers
Informal caregivers designated by patients who participated in M-PRP No intervention Semi-directive interview
Semi-directive interviews are individual interviews used in a qualitative approach to collect information in order to perform a thematic analysis
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
Semi-directive interviews are individual interviews used in a qualitative approach to collect information in order to perform a thematic analysis

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
During M-PRP or just after completion
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
During M-PRP or just after completion
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
During M-PRP or just after completion

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Investigators

  • Study Director: Nelly HERAUD, PhD, CLARIANE

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 19, 2024

Primary Completion (Actual)

March 28, 2025

Study Completion (Actual)

March 28, 2025

Study Registration Dates

First Submitted

June 4, 2024

First Submitted That Met QC Criteria

June 4, 2024

First Posted (Actual)

June 7, 2024

Study Record Updates

Last Update Posted (Actual)

April 6, 2025

Last Update Submitted That Met QC Criteria

April 3, 2025

Last Verified

April 1, 2025

More Information

Terms related to this study

Other Study ID Numbers

  • RECOORDS

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on COPD

Clinical Trials on Semi-directive interview

Subscribe