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

30 juni 2022 uppdaterad av: 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.

Studieöversikt

Status

Avslutad

Betingelser

Intervention / Behandling

Detaljerad beskrivning

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.

Studietyp

Interventionell

Inskrivning (Faktisk)

3

Fas

  • Inte tillämpbar

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studieorter

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

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

18 år och äldre (Vuxen, Äldre vuxen)

Tar emot friska volontärer

Nej

Kön som är behöriga för studier

Allt

Beskrivning

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)).

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Övrig
  • Tilldelning: N/A
  • Interventionsmodell: Enskild gruppuppgift
  • Maskning: Ingen (Open Label)

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Experimentell: 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).
Övrig: Web Platform
The intervention involves the use of the web platform for 12 months combined with a monthly phone follow-up.

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Change in Adherence of each participant
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Change in Exercise capacity
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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

Samarbetspartners och utredare

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Sponsor

Université de Sherbrooke

Publikationer och användbara länkar

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Allmänna publikationer

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Faktisk)

1 november 2020

Primärt slutförande (Faktisk)

1 november 2021

Avslutad studie (Faktisk)

31 december 2021

Studieregistreringsdatum

Först inskickad

20 februari 2020

Först inskickad som uppfyllde QC-kriterierna

23 februari 2020

Första postat (Faktisk)

26 februari 2020

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

6 juli 2022

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

30 juni 2022

Senast verifierad

1 juni 2022

Mer information

Termer relaterade till denna studie

Nyckelord

Andra studie-ID-nummer

  • 2020-3607

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