Clinical trial NCT04284865: Optimizing Maintenance for Patients with COPD Via a Web Platform - Case Study
Official title: Optimizing Maintenance for Patients with Chronic Obstructive Pulmonary Disease Following Pulmonary Rehabilitation Via a Web Platform - Case Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: COPD
Keywords: Self-management
Long-term care
Telehealth
Lead sponsor: Université de Sherbrooke
Sponsor class: OTHER
First posted: 2020-02-26
Enrollment: 3
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: Pulmonary rehabilitation (PR) has been shown to improve quality of life of people with COPD by decreasing their symptoms. However, the benefits obtained during PR tend to decrease within six months to one year after PR. The objective of this study is to implement a web platform following PR programs in order to improve COPD patients' adherence to self-management techniques. Therefore, the investigators want to verify whether the addition of a tele-management tool allows the gains obtained during PR to be retained over 3, 6 and 12 months. The hypothesis is that participants will maintain their PR gains if they use the platform.

Detailed description: Introduction: By 2020, chronic obstructive pulmonary disease (COPD) is projected to become the 3rd leading cause of death in the world. Pulmonary rehabilitation (PR) has been shown to improve quality of life of people with COPD by decreasing their symptoms. However, the benefits obtained during PR tend to decrease within six months to one year after PR.

The objective of this study is to implement a web platform following PR programs in order to improve COPD patients' adherence to self-management techniques. Specifically, the investigators will 1) evaluate the adherence to the use of the web platform and 2) the effects on exercise capacity, quality of life, the number of hospitalizations and exacerbations. Therefore, the investigators want to verify whether the addition of a tele-management tool allows the gains obtained during PR to be retained over 3, 6 and 12 months. The hypothesis is that patients will maintain their PR gains if they use the platform.

Methods: Participants with COPD will be selected in a PR group at CHUS Hôtel-Dieu de Sherbrooke. Their initial 10-week rehabilitation program will be followed by the use of a web-based tele-management platform for 12 months. Data will be collected at the beginning of PR (T1), end of the PR (T2), after three months of using the web platform (T3), after six months (Q4) and after 12 months (T5). To measure adherence, the research team will have access to a) the number of connections made on the site, b) the number of exercises performed, c) the duration and type of cardiorespiratory exercises as well as the muscular exercises filled in the logbook and d) the number of exercises performed (breathing, cardiorespiratory and muscular exercises) self-reported by the participants at the time of assessment. For the second objective, the measures used will be FEV1 for lung function, the 6-minutes walk test for exercise capacity, COPD Assessment Test for quality of life, modified BORG scale (0-10) and the medical research center (MRC) for the feeling of dyspnea, the number of hospitalizations over 3, 6 and 12 months (self-reported) and the number of exacerbations via medication taken from their pharmacist.

Eligibility criteria: Inclusion Criteria:

* Complete the PR program at CIUSSSS of Estrie-CHUS in Sherbrooke and finishing after December 2019
* To have a mild to very severe diagnosis of COPD (mild: forced expiratory volume in 1 second (FEV1) ) ≥ 80%, very severe: FEV1 \<30% and Tiffeneau score \<0.7)
* Have a score ≥2 on the Medical Research Council (MRC) dyspnea scale
* Have access to a computer, laptop or cell phone at home with an high speed internet service.

Exclusion Criteria:

* Inability to give informed consent
* Instable condition in the 4 weeks prior to the study (change in medication and symptoms such as dyspnea and sputum (colour and quantity)).

Primary outcomes:
measure: Change in Adherence of each participant
timeFrame: 3 months, 6 months and 12 months
measure: Change in Adherence of each participant
timeFrame: 3 months, 6 months and 12 months
measure: Change in Adherence of each participant
timeFrame: 3 months, 6 months and 12 months
measure: Change in Adherence of each participant
timeFrame: 3 months, 6 months and 12 months
Secondary outcomes:
measure: Change in Exercise capacity
timeFrame: pre-pulmonary rehabilitation, 0 months, 3 months, 6 months and 12 months
measure: Change of the Quality of life
timeFrame: pre-pulmonary rehabilitation, 0 months, 3 months, 6 months and 12 months
measure: Change in dyspnea
timeFrame: pre-pulmonary rehabilitation, 0 months, 3 months, 6 months and 12 months
measure: Change of Number of hospitalizations
timeFrame: pre-pulmonary rehabilitation, 0 months, 6 months and 12 months
measure: Change of Number of exacerbations
timeFrame: pre-pulmonary rehabilitation, 0 months, 6 months and 12 months
Other outcomes:
Locations:
city: Sherbrooke
country: Canada
facility: Université de Sherbrooke
state: Quebec
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.