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| ID | Type | Description | Link |
|---|---|---|---|
| 2017-A02393-50 | Other Identifier | ID-RCB number, ANSM | |
| PREPS-16-249 | Other Identifier | PREPS number, DGOS |
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difficulty of inclusion
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| Name | Class |
|---|---|
| Ministry of Health, France | OTHER_GOV |
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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.
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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| home group | Active Comparator |
| |
| center group | Active Comparator |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Home respiratory rehabilitation | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | At 2 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | at 6 months, at12 months |
| Percentage of patients expressing a preference marked for home-based respiratory rehabilitation or respiratory rehabilitation in center |
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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 :
Also, will not be included, the patient (s):
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| Name | Affiliation | Role |
|---|---|---|
| Olivier Le Rouzic, MD,PhD | University Hospital, Lille | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre hospitalier de béthune | Béthune | France | ||||
| CH de Béthune |
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| ID | Term |
|---|---|
| D029424 | Pulmonary Disease, Chronic Obstructive |
| ID | Term |
|---|---|
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D002908 | Chronic Disease |
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| Center respiratory rehabilitation | Other | 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 |
|
| 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 | The COPD assessment test (CAT) is a short questionnaire initially intended for assess quality of life and clinical impact of COPD | baseline, after RR (2 months); 6 months and12 months |
| 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. | baseline, after RR (2 months); 6 months and12 months |
| 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 | Baseline, after RR (2 months); 6 months and12 months |
| 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) | baseline |
| Béthune |
| France |
| Hôpital Calmette, CHU | Lille | France |
| CH de Loos | Loos | France |
| CH Victor Provot, Roubaix | Roubaix | France |
| CH de Tourcoing | Tourcoing | France |
| CH de Wattrelos | Wattrelos | France |
| D020969 |
| Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |