Respiratory Rehabilitation at Home vs in the Center for Patients With Chronic Obstructive Pulmonary Disease: Efficacy, Preferences and Costs
Overview
- Phase
- Not Applicable
- Status
- Terminated
- Sponsor
- University Hospital, Lille
- Enrollment
- 188
- Locations
- 7
- Primary Endpoint
- Change from baseline the 6 minutes Stepper test at 2 months
Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Supportive Care
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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,
Outcomes
Primary Outcomes
Change from baseline the 6 minutes Stepper test at 2 months
Time Frame: 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 Outcomes
- Percentage of patients expressing a preference marked for home-based respiratory rehabilitation or respiratory rehabilitation in center(Baseline)
- Change from baseline the 6 minutes Stepper test at 6 and 12 months(at 6 months, at12 months)
- Cost of interventions: respiratory rehabilitation in center or at home(At 12 months)
- Change from Baseline COPD Assessment Test (CAT) at 2,6,12 months(baseline, after RR (2 months); 6 months and12 months)
- Change from Baseline Modified Medical Research Council (MMRC) Dyspnea Scale at 2,6,12 months(baseline, after RR (2 months); 6 months and12 months)
- Change from Baseline Anxiety and Depression (HAD) at 2,6,12 months(Baseline, after RR (2 months); 6 months and12 months)
- EPICES score(baseline)