Ignite Creation Date:
2024-05-06 @ 3:12 PM
Last Modification Date:
2024-10-26 @ 1:44 PM
Study NCT ID:
NCT04550741
Status:
RECRUITING
Last Update Posted:
2023-09-14
First Post:
2020-06-29
Brief Title:
Long-term Maintenance Benefits of a Pulmonary Rehabilitation Program Using a Mobile Digital Solution a Prospective Randomized Controlled Multicenter Study in a Population of COPD Patients
Sponsor:
University Hospital Montpellier
Organization:
University Hospital Montpellier
Study Overview
Official Title:
Long-term Maintenance Benefits of a Pulmonary Rehabilitation Program Using a Mobile Digital Solution a Prospective Randomized Controlled Multicenter Study in a Population of COPD Patients
Status:
RECRUITING
Status Verified Date:
2023-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
m-Rehab COPD
Brief Summary:
Chronic obstructive pulmonary disease COPD is a public health problem high prevalence increasing morbidity and mortality impact on health costs Pulmonary rehabilitation PR is a multidisciplinary intervention combining exercise training therapeutic education psychosocial and behavioral interventions Its effects are beneficial in the short and medium terms but are limited in time between 6 and 12 months for patients who do not pursue regular physical activity PA in post-rehabilitation and who do not adopt behavioral changes for health by loss of motivation Maintaining the long-term benefits acquired during a short-term PR program is therefore a major issue in the management of COPD The recent development of remote rehabilitation is a promising approach that has been studied in few studies
In a randomized controlled and multicenter study we propose to test the hypothesis that the use of a mobile telerehabilitation solution will allow COPD patients to mainain at long-term the benefits acquired during a short-temr programm and therfore improve their quality of life
PA in post-rehabilitation and who do not adopt behavioral changes for health by loss of motivation Maintaining the long-term benefits acquired during a short-term PR program is therefore a major issue in the management of COPD The recent development of remote rehabilitation is a promising approach that has been studied in few studies
In a randomized controlled and multicenter study we propose to test the hypothesis that the use of a mobile telerehabilitation solution will allow COPD patients to mainain at long-term the benefits acquired during a short-temr programm and therfore improve their quality of life
In a randomized controlled and multicenter study we propose to test the hypothesis that the use of a mobile telerehabilitation solution will allow COPD patients to mainain at long-term the benefits acquired during a short-temr programm and therfore improve their quality of life
PA in post-rehabilitation and who do not adopt behavioral changes for health by loss of motivation Maintaining the long-term benefits acquired during a short-term PR program is therefore a major issue in the management of COPD The recent development of remote rehabilitation is a promising approach that has been studied in few studies
In a randomized controlled and multicenter study we propose to test the hypothesis that the use of a mobile telerehabilitation solution will allow COPD patients to mainain at long-term the benefits acquired during a short-temr programm and therfore improve their quality of life
Detailed Description:
Exclusion criteria
Presence of contraindications for exercise training neuromuscular disease orthopedic cause
Patients with significant and unstable cardiovascular disease
Inability to understand andor answer questionnaires
Refusal to use a smartphone or digital device
Unable to access an internet connection at home
Analysis
The main analysis will be the univariate intention-to-treat analysis of the primary outcome
Secondary analyzes will include
Analysis with intention to treat secondary endpoints
Multivariate analysis of the efficiency criteria
Univariate and multivariate medico - economic cost - utility analyzes with their respective sensitivity analyzes
Protocol
This prospective randomized study with two parallel arms controlled against standard chronic care will be multicentric and open
Patients included will be patients diagnosed with COPD who are on RR for four weeks in one of the three centers participating in the study
Participation in the study will be offered after verification of the eligibility criteria during the 3rd week of the stay
The information note will then be provided to them
After obtaining consent the volunteers will be included in the study at the start of the 4th week and randomized into two arms
- Experimental group of 100 patients using the M-Réhab BPCO telerehabilitation solution The solution will be provided during the fourth and final week of RRs stay during which patients will be trained to use all of the solutions features Patients will carry out the entire post-rehabilitation using the remote rehabilitation solution and will benefit from medical assessments by teleconsultation at 1 3 6 and 12 months as well as assessments at 3 6 and 12 months by filling electronic auto-questionnaires followed by a telephone quality control if necessary A final evaluation at 12 months by videoconference will be carried out at the patients home
Control group of 100 patients following usual standard chronic care Patients will receive during the last week of stay in the center the usual advice to continue physical activity and nutritional advice at home The evaluations at 3 6 and 12 months will be done by electronic filling of auto-questionnaires followed by a telephone quality control if necessary A final evaluation at 12 months by videoconference will be carried out at the patients home
The duration of the inclusions is 18 months and the follow-up will be carried out over 12 months
Presence of contraindications for exercise training neuromuscular disease orthopedic cause
Patients with significant and unstable cardiovascular disease
Inability to understand andor answer questionnaires
Refusal to use a smartphone or digital device
Unable to access an internet connection at home
Analysis
The main analysis will be the univariate intention-to-treat analysis of the primary outcome
Secondary analyzes will include
Analysis with intention to treat secondary endpoints
Multivariate analysis of the efficiency criteria
Univariate and multivariate medico - economic cost - utility analyzes with their respective sensitivity analyzes
Protocol
This prospective randomized study with two parallel arms controlled against standard chronic care will be multicentric and open
Patients included will be patients diagnosed with COPD who are on RR for four weeks in one of the three centers participating in the study
Participation in the study will be offered after verification of the eligibility criteria during the 3rd week of the stay
The information note will then be provided to them
After obtaining consent the volunteers will be included in the study at the start of the 4th week and randomized into two arms
- Experimental group of 100 patients using the M-Réhab BPCO telerehabilitation solution The solution will be provided during the fourth and final week of RRs stay during which patients will be trained to use all of the solutions features Patients will carry out the entire post-rehabilitation using the remote rehabilitation solution and will benefit from medical assessments by teleconsultation at 1 3 6 and 12 months as well as assessments at 3 6 and 12 months by filling electronic auto-questionnaires followed by a telephone quality control if necessary A final evaluation at 12 months by videoconference will be carried out at the patients home
Control group of 100 patients following usual standard chronic care Patients will receive during the last week of stay in the center the usual advice to continue physical activity and nutritional advice at home The evaluations at 3 6 and 12 months will be done by electronic filling of auto-questionnaires followed by a telephone quality control if necessary A final evaluation at 12 months by videoconference will be carried out at the patients home
The duration of the inclusions is 18 months and the follow-up will be carried out over 12 months
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None