- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06448559
Feedback on the New Profession of Care Manager in Maintenance Pulmonary Rehabilitation Programmes (RECOORDS)
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
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
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
-
Lodeve, France
- Clinique Souffle La Vallonie
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
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
- 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
Exclusion Criteria:
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
Study Plan
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
Sponsor
Investigators
- Study Director: Nelly HERAUD, PhD, CLARIANE
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
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)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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
-
University Medical Center GroningenCompleted
-
Ryme Medical, Inc.Not yet recruitingCOPD | Lung Disease, Chronic Obstructive | COPD Patients | COPD Acute Exacerbation | COPD (Chronic Obstructive Pulmonary Disease) | Lung Disease Airways | COPD Exacerbations
-
Insel Gruppe AG, University Hospital BernUniversity Hospital, Geneva; Cantonal Hospital St. Gallen, SwitzerlandNot yet recruiting
-
Istituto Nazionale di Ricovero e Cura per AnzianiRecruiting
-
Bio-Sensing Solutions S.L. (DyCare)Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau; Centre...Recruiting
-
Sir Run Run Shaw HospitalRecruiting
-
The First Affiliated Hospital of Guangzhou Medical...Recruiting
-
Association des Réseaux BronchioliteLaboratoire Système et Matériaux pour la Mécatronique (SYMME)Recruiting
-
Polytechnic Institute of PortoNippon Gases PortugalRecruiting
-
China-Japan Friendship HospitalNot yet recruiting
Clinical Trials on Semi-directive interview
-
Centre Hospitalier Universitaire DijonCompleted
-
University Hospital, LilleTerminatedMalignant HaemopathyFrance
-
Institut de Cancérologie de la LoireCompleted
-
Centre Hospitalier Universitaire DijonCompletedCerebral Palsy | Infant | NeonatalFrance
-
Hospices Civils de LyonRecruitingBreast CancerFrance
-
Assistance Publique - Hôpitaux de ParisNot yet recruiting
-
Assistance Publique - Hôpitaux de ParisURC-CIC Paris Descartes Necker CochinCompletedHealthcare Worker Facing COVID-19France
-
Hospices Civils de LyonRecruiting
-
University Hospital, MontpellierCompletedOppositional Defiant Disorder With Familial SettingFrance
-
Centre Leon BerardTerminated