Chronic Obstructive Pulmonary Disease
Conditions
Keywords
Pulmonary rehabilitation, home-based
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.
Interventions
OTHERHome respiratory rehabilitation
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.
OTHERCenter respiratory rehabilitation
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
Sponsors
Ministry of Health, France
University Hospital, Lille
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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, * unable to participate in the entire study, * not covered by the social security scheme, * refusing to sign the consent,
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline the 6 minutes Stepper test at 2 months | 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
| Measure | Time frame | Description |
|---|---|---|
| Percentage of patients expressing a preference marked for home-based respiratory rehabilitation or respiratory rehabilitation in center | Baseline | — |
| 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 | The COPD assessment test (CAT) is a short questionnaire initially intended for assess quality of life and clinical impact of COPD |
| Change from baseline the 6 minutes Stepper test at 6 and 12 months | at 6 months, at12 months | The 6 minutes stepper test (ST6), performed on a Stepper allows to analyze the number of strokes (or steps) performed in 6 minutes |
| Change from Baseline Anxiety and Depression (HAD) at 2,6,12 months | Baseline, after RR (2 months); 6 months and12 months | To determine the levels of anxiety and depression that a COPD patients are experiencing |
| EPICES score | baseline | 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) |
| Change from Baseline Modified Medical Research Council (MMRC) Dyspnea Scale at 2,6,12 months | baseline, after RR (2 months); 6 months and12 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. |
Countries
France
Outcome results
None listed