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Completed

NCT Number: NCT04284865

Optimizing Maintenance for Patients with COPD 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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Université de Sherbrooke

Sherbrooke, Quebec, J1H 5N4, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)).

Treatment and study plan

Web Platform

Other

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

Primary outcomes

  1. Change in Adherence of each participant

    Time frame: 3 months, 6 months and 12 months

    The number of connections made on the site

  2. 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. 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

  4. 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

  1. 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)

  2. 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)

  3. 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)

  4. Change of Number of hospitalizations

    Time frame: pre-pulmonary rehabilitation, 0 months, 6 months and 12 months

    Self-reported

  5. 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

Sponsors and collaborators

Lead sponsor

Université de Sherbrooke

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Feb 26, 2020
Registry last updated
Jan 14, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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