Optimizing Maintenance for Patients with COPD Via a Web Platform - Case Study

NCT ID: NCT04284865

Last Updated: 2025-01-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 3 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-11-01
• Study Completion Date: 2021-12-31

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.

Conditions

COPD

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Intervention group

The web platform includes three respiratory exercises: diaphragmatic breathing, thoracic expansion exercise and thoracic expansion exercise assisted upper limbs. It is suggested to do each of the three exercises once a day (AM and PM), four repetitions each. An electronic logbook is also available on the platform to record the duration and the type of others cardiorespiratory exercise of their choice (cycling, walking, using stairs, etc.) as well as strengthening (upper and lower body).

Group Type: EXPERIMENTAL

Web Platform

Intervention Type: OTHER

The intervention involves the use of the web platform for 12 months combined with a monthly phone follow-up.

Interventions

Web Platform

The intervention involves the use of the web platform for 12 months combined with a monthly phone follow-up.

Intervention Type: OTHER

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)).

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Université de Sherbrooke

OTHER

Sponsor Role: lead

Responsible Party

Nicole Marquis

adjunct professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Université de Sherbrooke

Sherbrooke, Quebec, Canada

Countries

Canada

References

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.

Reference Type: DERIVED

PMID: 33511633 (View on PubMed)

Other Identifiers

2020-3607

Identifier Type: -

Identifier Source: org_study_id