NCT06448559

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
16

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Aug 2024

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

June 4, 2024

Completed
3 days until next milestone

First Posted

Study publicly available on registry

June 7, 2024

Completed
2 months until next milestone

Study Start

First participant enrolled

August 19, 2024

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 28, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 28, 2025

Completed
Last Updated

April 6, 2025

Status Verified

April 1, 2025

Enrollment Period

7 months

First QC Date

June 4, 2024

Last Update Submit

April 3, 2025

Conditions

Outcome Measures

Primary Outcomes (3)

  • Typology and categorization of definition and perception of the profession of care manager

    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

    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

    collected through interviews with each group

    During M-PRP or just after completion

Study Arms (3)

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

Other: Semi-directive interview

Informal caregivers

Informal caregivers designated by patients who participated in M-PRP No intervention Semi-directive interview

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

Other: Semi-directive interview

Interventions

Semi-directive interviews are individual interviews used in a qualitative approach to collect information in order to perform a thematic analysis

Care-managersInformal caregiversPatients with Chronic obstructive pulmonary disease (COPD)

Eligibility Criteria

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

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

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Clinique Souffle La Vallonie

Lodève, France

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, ObstructiveLung DiseasesRespiratory Tract DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Nelly HERAUD, PhD

    CLARIANE

    STUDY DIRECTOR

Study Design

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

Study Record Dates

First Submitted

June 4, 2024

First Posted

June 7, 2024

Study Start

August 19, 2024

Primary Completion

March 28, 2025

Study Completion

March 28, 2025

Last Updated

April 6, 2025

Record last verified: 2025-04

Locations