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

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

Sponsors

Lead Sponsor: University Hospital, Montpellier

Source University Hospital, Montpellier
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.

Overall Status Not yet recruiting
Start Date October 1, 2020
Completion Date May 2024
Primary Completion Date October 1, 2023
Phase N/A
Study Type Interventional
Primary Outcome
Measure Time Frame
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 12 months
Secondary Outcome
Measure Time Frame
Pre-intentional variables baseline
Post-intentional variables 6 months
Physical Activity behaviors. 12 months
Predictive model of physical activity behavior At 12 months
Enrollment 200
Condition
Intervention

Intervention Type: Other

Intervention Name: telerehabilitation

Description: After obtaining consent, the volunteers will be included in the study at the start of the 4th week and randomized into two arms: Experimental and Control group

Arm Group Label: Telerehabilitation

Other Name: Digital solution of telerehabilitation with remote connected objects

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.

Gender: All

Minimum Age: 40 Years

Maximum Age: 78 Years

Healthy Volunteers: No

Overall Contact

Last Name: Maurice HAYOT, MD, PhD

Phone: +33 467 335 908

Email: [email protected]

Location
Facility: Contact: Centre hopsitalier universitaire de Montpellier Maurice HAYOT, MD, PhD +33 467 335 908 [email protected]
Location Countries

France

Verification Date

September 2020

Responsible Party

Type: Sponsor

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Label: Telerehabilitation

Type: Experimental

Description: 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.

Label: Standard chronic care

Type: No Intervention

Description: 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.

Acronym m-Rehab COPD
Study Design Info

Allocation: Randomized

Intervention Model: Parallel Assignment

Primary Purpose: Treatment

Masking: None (Open Label)

Masking Description: This study will be an Open study. For the primary outcome the analysis will be blind to the investigator

Source: ClinicalTrials.gov