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Clinical Trials/NCT04284865
NCT04284865
Completed
Not Applicable

Optimizing Maintenance for Patients with Chronic Obstructive Pulmonary Disease Following Pulmonary Rehabilitation Via a Web Platform - Case Study

Université de Sherbrooke1 site in 1 country3 target enrollmentNovember 1, 2020
ConditionsCOPD

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
COPD
Sponsor
Université de Sherbrooke
Enrollment
3
Locations
1
Primary Endpoint
Change in Adherence of each participant
Status
Completed
Last Updated
last year

Overview

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.

Registry
clinicaltrials.gov
Start Date
November 1, 2020
End Date
December 31, 2021
Last Updated
last year
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Nicole Marquis

adjunct professor

Université de Sherbrooke

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)).

Outcomes

Primary Outcomes

Change in Adherence of each participant

Time Frame: 3 months, 6 months and 12 months

the number of exercises performed (breathing, cardiorespiratory and muscular exercises) self-reported by the participants

Secondary Outcomes

  • Change in Exercise capacity(pre-pulmonary rehabilitation, 0 months, 3 months, 6 months and 12 months)
  • Change of the Quality of life(pre-pulmonary rehabilitation, 0 months, 3 months, 6 months and 12 months)
  • Change in dyspnea(pre-pulmonary rehabilitation, 0 months, 3 months, 6 months and 12 months)
  • Change of Number of hospitalizations(pre-pulmonary rehabilitation, 0 months, 6 months and 12 months)
  • Change of Number of exacerbations(pre-pulmonary rehabilitation, 0 months, 6 months and 12 months)

Study Sites (1)

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