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

January 10, 2025 updated by: Nicole Marquis, Université de Sherbrooke

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

3

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Quebec
      • Sherbrooke, Quebec, Canada, J1H 5N4
        • Université de Sherbrooke

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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)).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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).
The intervention involves the use of the web platform for 12 months combined with a monthly phone follow-up.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Adherence of each participant
Time Frame: 3 months, 6 months and 12 months
The number of connections made on the site
3 months, 6 months and 12 months
Change in Adherence of each participant
Time Frame: 3 months, 6 months and 12 months
the number of exercises performed on the platform web
3 months, 6 months and 12 months
Change in Adherence of each participant
Time Frame: 3 months, 6 months and 12 months
Number of entry/week in the logbook on the platform web
3 months, 6 months and 12 months
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
3 months, 6 months and 12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Exercise capacity
Time Frame: pre-pulmonary rehabilitation, 0 months, 3 months, 6 months and 12 months
six minute walk test (distance reach (m) by walking for 6 minutes)
pre-pulmonary rehabilitation, 0 months, 3 months, 6 months and 12 months
Change of the Quality of life
Time Frame: pre-pulmonary rehabilitation, 0 months, 3 months, 6 months and 12 months
COPD assessment test (CAT) (measure the impact of COPD on a person's life, and how this changes over time)
pre-pulmonary rehabilitation, 0 months, 3 months, 6 months and 12 months
Change in dyspnea
Time Frame: pre-pulmonary rehabilitation, 0 months, 3 months, 6 months and 12 months
Borg Scale and the medical research center (MRC) scale (scale of 0 to 10 where 0 is no effort and 10 , maximum effort)
pre-pulmonary rehabilitation, 0 months, 3 months, 6 months and 12 months
Change of Number of hospitalizations
Time Frame: pre-pulmonary rehabilitation, 0 months, 6 months and 12 months
Self-reported
pre-pulmonary rehabilitation, 0 months, 6 months and 12 months
Change of Number of exacerbations
Time Frame: pre-pulmonary rehabilitation, 0 months, 6 months and 12 months
We will be able to know to number of exacerbations by the medication taken from the pharmacist of each participant
pre-pulmonary rehabilitation, 0 months, 6 months and 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 1, 2020

Primary Completion (Actual)

November 1, 2021

Study Completion (Actual)

December 31, 2021

Study Registration Dates

First Submitted

February 20, 2020

First Submitted That Met QC Criteria

February 23, 2020

First Posted (Actual)

February 26, 2020

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

January 10, 2025

Last Verified

June 1, 2022

More Information

Terms related to this study

Other Study ID Numbers

  • 2020-3607

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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