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Respiratory Rehabilitation for Patients With Chronic Obstructive Pulmonary Disease (REHABDO)

Primary Purpose

Chronic Obstructive Pulmonary Disease

Status

Unknown status

Phase

Not Applicable

Locations

France

Study Type

Interventional

Intervention

Home respiratory rehabilitation

Center respiratory rehabilitation

About this trial

This is an interventional supportive care trial for Chronic Obstructive Pulmonary Disease focused on measuring Pulmonary rehabilitation, home-based

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Exclusion Criteria:

According to the recommendations, HAS, SPLF, ERS / ATS will not be included any patient having :

co-morbidities including unstabilized cardiovascular disease,
significant cognitive disorders: patients with a history of pathologies neurodegenerative with loss of mental faculties (example: Alzheimer)
psychiatric disorders: patients with impaired judgment and perception
neurological or orthopedic disorders that do not allow the realization of physical activities

Also, will not be included, the patient (s):

waiting for lung transplantation,
pregnant or nursing,
in an emergency situation
unable to receive enlightened information,
unable to participate in the entire study,
not covered by the social security scheme,
refusing to sign the consent,

Sites / Locations

Centre hospitalier de béthuneRecruiting
CH de BéthuneRecruiting
Hôpital Calmette, CHURecruiting
CH de LoosRecruiting
CH Victor Provot, RoubaixRecruiting
CH de TourcoingRecruiting
CH de WattrelosRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

home group

center group

Arm Description

Outcomes

Primary Outcome Measures

Change from baseline the 6 minutes Stepper test at 2 months

The 6 minutes stepper test (ST6), performed on a Stepper allows to analyze the number of strokes (or steps) performed in 6 minutes

Secondary Outcome Measures

Change from baseline the 6 minutes Stepper test at 6 and 12 months

The 6 minutes stepper test (ST6), performed on a Stepper allows to analyze the number of strokes (or steps) performed in 6 minutes

Percentage of patients expressing a preference marked for home-based respiratory rehabilitation or respiratory rehabilitation in center

Cost of interventions: respiratory rehabilitation in center or at home

Change from Baseline COPD Assessment Test (CAT) at 2,6,12 months

The COPD assessment test (CAT) is a short questionnaire initially intended for assess quality of life and clinical impact of COPD

Change from Baseline Modified Medical Research Council (MMRC) Dyspnea Scale at 2,6,12 months

The scale measures a person's limitation base on a scale of 0-4 and uses the final value to determine how much disability is caused by shortness of breath.Five-option grading system called the Modified Medical Research Council (MMRC) Dyspnea Scale.

Change from Baseline Anxiety and Depression (HAD) at 2,6,12 months

To determine the levels of anxiety and depression that a COPD patients are experiencing

EPICES score

EPICES score (Assessment of the precariousness and health inequalities in the Health Examination Centers, French) is an individual indicator of precariousness ,Self-administered questionnaire,quantify the level of social vulnerability and precariousness. It ranges from zero (no vulnerability) to 100 (maximum vunerability)

Full Information

NCT ID

NCT03453606

First Posted

February 16, 2018

Last Updated

August 24, 2020

Sponsor

University Hospital, Lille

Collaborators

Ministry of Health, France

1. Study Identification

Unique Protocol Identification Number

NCT03453606

Brief Title

Respiratory Rehabilitation for Patients With Chronic Obstructive Pulmonary Disease

Acronym

REHABDO

Official Title

Respiratory Rehabilitation at Home vs in the Center for Patients With Chronic Obstructive Pulmonary Disease: Efficacy, Preferences and Costs

Study Type

Interventional

2. Study Status

Record Verification Date

August 2020

Overall Recruitment Status

Unknown status

Study Start Date

October 24, 2018 (Actual)

Primary Completion Date

January 2022 (Anticipated)

Study Completion Date

January 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

University Hospital, Lille

Collaborators

Ministry of Health, France

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

The aim of this clinical trial is to establish the non-inferiority of home-based respiratory rehabilitation compared to respiratory rehabilitation in center in terms of exercise tolerance as evaluated by the 6 minutes Stepper test.. This trial will also 1°) evaluate the Medico-economic aspects of the home-based Respiratory rehabilitation versus respiratory Rehabilitation in center; 2°) analyse the patient preferences between home-based respiratory rehabilitation and respiratory rehabilitation in center and 3°) Compare home-based respiratory rehabilitation vs respiratory rehabilitation in center in terms of dyspnea, quality of life, anxiety and depression.

Detailed Description

The purpose of this study is to perform a comparative analysis of the clinical and medico-economic effectiveness of center-based RR versus home-based RR in the departments of Nord and Pas de Calais in France. All COPD patients eligible for RR and willing to participate in the study will be followed. Patient preferences will be evaluated at inclusion. After presentation of both RR modalities, patients expressing a strong preference for one or other of the terms will be taken care of according to their wishes. Indifferent patients between the two RR modalities will be randomized. This design is justified in the light of three cases: It is impossible to evaluate blind intervention, The effectiveness of RR depends on patient preferences, Patients' adherence to the protocol is facilitated.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Chronic Obstructive Pulmonary Disease

Keywords

Pulmonary rehabilitation, home-based

7. Study Design

Primary Purpose

Supportive Care

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

670 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

home group

Arm Type

Active Comparator

Arm Title

center group

Arm Type

Active Comparator

Intervention Type

Other

Intervention Name(s)

Home respiratory rehabilitation

Intervention Description

Home care is individual (often with the spouse or the carer), during 1h30, one visit per week for 8 weeks, after completion of the educational diagnosis, under direct supervision of a member of the team, with continued physical activities in autonomy the others days of the week, according to a personalized action plan. No visit is scheduled in the pulmonologist, the general practitioner or in the rehabilitation center. The team includes pulmonologist, nurses, dietician, socio-medical beautician and a administrative assistant.

Intervention Type

Other

Intervention Name(s)

Center respiratory rehabilitation

Intervention Description

In an outpatient setting, the course is performed in groups of 6 to 8 patients, during sessions from 3 to 7 am, under the direction of health professionals, 3 to 5 times a week, for 4 to 6 weeks, for a total of 20 to 24 sessions. Internally, patients come to "complete" hospitalization for 4 weeks. This duration can be modulated according to the evolution of the patients. Supervision is carried out by the entire team including pulmonologists, nurses, physiotherapists, psychologists, activity professors adapted physicists, dietician

Primary Outcome Measure Information:

Title

Change from baseline the 6 minutes Stepper test at 2 months

Description

The 6 minutes stepper test (ST6), performed on a Stepper allows to analyze the number of strokes (or steps) performed in 6 minutes

Time Frame

At 2 months

Secondary Outcome Measure Information:

Title

Change from baseline the 6 minutes Stepper test at 6 and 12 months

Description

The 6 minutes stepper test (ST6), performed on a Stepper allows to analyze the number of strokes (or steps) performed in 6 minutes

Time Frame

at 6 months, at12 months

Title

Percentage of patients expressing a preference marked for home-based respiratory rehabilitation or respiratory rehabilitation in center

Time Frame

Baseline

Title

Cost of interventions: respiratory rehabilitation in center or at home

Time Frame

At 12 months

Title

Change from Baseline COPD Assessment Test (CAT) at 2,6,12 months

Description

The COPD assessment test (CAT) is a short questionnaire initially intended for assess quality of life and clinical impact of COPD

Time Frame

baseline, after RR (2 months); 6 months and12 months

Title

Change from Baseline Modified Medical Research Council (MMRC) Dyspnea Scale at 2,6,12 months

Description

Time Frame

baseline, after RR (2 months); 6 months and12 months

Title

Change from Baseline Anxiety and Depression (HAD) at 2,6,12 months

Description

To determine the levels of anxiety and depression that a COPD patients are experiencing

Time Frame

Baseline, after RR (2 months); 6 months and12 months

Title

EPICES score

Description

Time Frame

baseline

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria:According to HAS recommendations, SPLF, ERS / ATS (3) (18) (19) can be included any patient, over 18 years old, with stage II - III - IV COPD presenting disabling dyspnoea in activities of daily living, and / or in the course of acute exacerbation of COPD (EABPCO), with no other respiratory pathology diagnosed. Exclusion Criteria: According to the recommendations, HAS, SPLF, ERS / ATS will not be included any patient having : co-morbidities including unstabilized cardiovascular disease, significant cognitive disorders: patients with a history of pathologies neurodegenerative with loss of mental faculties (example: Alzheimer) psychiatric disorders: patients with impaired judgment and perception neurological or orthopedic disorders that do not allow the realization of physical activities Also, will not be included, the patient (s): waiting for lung transplantation, pregnant or nursing, in an emergency situation unable to receive enlightened information, unable to participate in the entire study, not covered by the social security scheme, refusing to sign the consent,

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Olivier Le rouzic, MD,PhD

Phone

3.20.44.59.48

Ext

+33

olivier.lerouzic@chru-lille.fr

First Name & Middle Initial & Last Name or Official Title & Degree

Benoit Wallaert, MD,PhD

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Olivier Le Rouzic, MD,PhD

Organizational Affiliation

University Hospital, Lille

Official's Role

Principal Investigator

Facility Information:

Facility Name

Centre hospitalier de béthune

City

Béthune

Country

France

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Frédéric Bart, MD

Facility Name

CH de Béthune

City

Béthune

Country

France

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Fréderic Bart, MD

Facility Name

Hôpital Calmette, CHU

City

Lille

Country

France

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Olivier Le Rouzic, MD

Facility Name

CH de Loos

City

Loos

Country

France

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Said Benkharraz, MD

Facility Name

CH Victor Provot, Roubaix

City

Roubaix

Country

France

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

François Steenhouwer, MD

Facility Name

CH de Tourcoing

City

Tourcoing

Country

France

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Thirard Laurence, MD

Facility Name

CH de Wattrelos

City

Wattrelos

Country

France

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Alain Strecker, MD

12. IPD Sharing Statement

Learn more about this trial

Respiratory Rehabilitation for Patients With Chronic Obstructive Pulmonary Disease

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