Clinical trial NCT04550741: 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
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Obstructive Pulmonary Disease
Keywords: Chronic obstructive pulmonary disease
Telerehabilitation
Telemedicine
Exercise training
Quality of life
E-health
Connected objects
Care manager
Lead sponsor: University Hospital, Montpellier
Sponsor class: OTHER
First posted: 2020-09-16
Enrollment: 200
Sex: ALL
Minimum age (years): 40
Maximum age (years): 78
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Detailed description: Exclusion criteria:

* Presence of contraindications for exercise training (neuromuscular disease, orthopedic cause).
* Patients with significant and unstable cardiovascular disease.
* Inability to understand and/or 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 RR's stay during which patients will be trained to use all of the solution's 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 patient's 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 patient's home.

The duration of the inclusions is 18 months and the follow-up will be carried out over 12 months.

Eligibility criteria: Inclusion Criteria:

* Patients diagnosed with COPD according to the GOLD (Global Initiative for Chronic Obstructive Lung Disease) creteria.
* Presence of an incompletely reversible obstructive ventilatory disorder defined by a report VEMS / CVF lower than the lower limit of normal post-bronchodilator.
* Patient on RR for four weeks in respiratory rehabilitation center.
* Aged between 40 and 78 years.

Exclusion Criteria:

* Presence of contraindications for exercise training (neuromuscular disease, orthopedic cause).
* Patients with significant and unstable cardiovascular disease.
* Inability to understand and/or answer questionnaires.
* Refusal to use a smartphone or digital device.
* Unable to access an internet connection at home.

Primary outcomes:
measure: Quality of Life of chronic obstructive pulmonary disease patients after a 1-year téléherabilitaion versus standard care program, after an initial short-term pulmonary rehabilitation program
timeFrame: 12 months
Secondary outcomes:
measure: Pre-intentional variables
timeFrame: baseline
measure: Post-intentional variables
timeFrame: 6 months
measure: Physical Activity behaviors.
timeFrame: 12 months
measure: Predictive model of physical activity behavior
timeFrame: At 12 months
Other outcomes:
Locations:
city: Montpellier
country: France
facility: Centre hopsitalier universitaire de Montpellier
state: Occitanie
city: Osséja
country: France
facility: Clinique du Souffle
Study officials:
References:
citation: Cox NS, Dal Corso S, Hansen H, McDonald CF, Hill CJ, Zanaboni P, Alison JA, O'Halloran P, Macdonald H, Holland AE. Telerehabilitation for chronic respiratory disease. Cochrane Database Syst Rev. 2021 Jan 29;1(1):CD013040. doi: 10.1002/14651858.CD013040.pub2.