Clinical trial NCT03453606: Respiratory Rehabilitation for Patients With Chronic Obstructive Pulmonary Disease
Official title: Respiratory Rehabilitation at Home vs in the Center for Patients With Chronic Obstructive Pulmonary Disease: Efficacy, Preferences and Costs
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Chronic Obstructive Pulmonary Disease
Keywords: Pulmonary rehabilitation
home-based
Lead sponsor: University Hospital, Lille
Sponsor class: OTHER
Collaborators: name: Ministry of Health, France
First posted: 2018-03-05
Enrollment: 670
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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,

Primary outcomes:
measure: Change from baseline the 6 minutes Stepper test at 2 months
timeFrame: At 2 months
Secondary outcomes:
measure: Change from baseline the 6 minutes Stepper test at 6 and 12 months
timeFrame: at 6 months, at12 months
measure: Percentage of patients expressing a preference marked for home-based respiratory rehabilitation or respiratory rehabilitation in center
timeFrame: Baseline
measure: Cost of interventions: respiratory rehabilitation in center or at home
timeFrame: At 12 months
measure: Change from Baseline COPD Assessment Test (CAT) at 2,6,12 months
timeFrame: baseline, after RR (2 months); 6 months and12 months
measure: Change from Baseline Modified Medical Research Council (MMRC) Dyspnea Scale at 2,6,12 months
timeFrame: baseline, after RR (2 months); 6 months and12 months
measure: Change from Baseline Anxiety and Depression (HAD) at 2,6,12 months
timeFrame: Baseline, after RR (2 months); 6 months and12 months
measure: EPICES score
timeFrame: baseline
Other outcomes:
Locations:
city: Béthune
country: France
facility: Centre hospitalier de béthune
city: Béthune
country: France
facility: CH de Béthune
city: Lille
country: France
facility: Hôpital Calmette, CHU
city: Loos
country: France
facility: CH de Loos
city: Roubaix
country: France
facility: CH Victor Provot, Roubaix
city: Tourcoing
country: France
facility: CH de Tourcoing
city: Wattrelos
country: France
facility: CH de Wattrelos
Study officials:
affiliation: University Hospital, Lille
name: Olivier Le Rouzic, MD,PhD
role: PRINCIPAL_INVESTIGATOR
References: