- ICH GCP
- US-Register für klinische Studien
- Klinische Studie NCT01423227
Benefits and Costs of Home-based Pulmonary Rehabilitation in Chronic Obstructive Pulmonary Disease (HomeBase)
Pulmonary rehabilitation is an effective treatment for people with chronic obstructive pulmonary disease (COPD) which improves symptoms, reduces hospitalisation and lowers healthcare costs. However less than 1% of Australians with COPD receive pulmonary rehabilitation each year, due to poor access to programs and high levels of disability. This randomised controlled trial will examine the benefits and costs of a novel, entirely home-based pulmonary rehabilitation program for COPD. We hypothesise that home-based pulmonary rehabilitation can deliver equivalent clinical outcomes at lower cost than the centre-based program.
We will randomly allocate 144 people with COPD to undertake either standard pulmonary rehabilitation in a hospital setting, or a low-cost home-based program. Those who undertake pulmonary rehabilitation in the hospital setting will attend the hospital twice each week for eight weeks for supervised exercise training and education. People in the home pulmonary rehabilitation group will receive one home visit and weekly telephone calls for eight weeks, for supervision and mentoring of exercise and provision of education. We will compare the number of people who complete the program in each setting. We will also test whether the groups have similar results for the standard pulmonary rehabilitation outcomes of breathlessness, quality of life and exercise capacity, at the end of the program and 12 months later. We will compare health care costs and personal costs between groups after 12 months.
If home-based pulmonary rehabilitation can improve uptake of this important treatment, deliver good clinical outcomes and reduce costs this will have significant and long-lasting benefits for patients, the community and the health system
Studienübersicht
Status
Bedingungen
Intervention / Behandlung
Studientyp
Einschreibung (Voraussichtlich)
Phase
- Phase 3
Kontakte und Standorte
Studienorte
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Victoria
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Heidelberg, Victoria, Australien, 3084
- Austin Health
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Melbourne, Victoria, Australien, 3004
- Alfred Health
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Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
Akzeptiert gesunde Freiwillige
Studienberechtigte Geschlechter
Beschreibung
Inclusion Criteria:
- current or former smokers of at least 10 packet years
- aged 40 years or over
- diagnosis of COPD confirmed on spirometry.
Exclusion Criteria:
- previous diagnosis of asthma
- have attended a pulmonary rehabilitation program in the last two years
- exacerbation of COPD within the last four weeks
- have comorbidities which prevent participation in an exercise training program
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Behandlung
- Zuteilung: Zufällig
- Interventionsmodell: Parallele Zuordnung
- Maskierung: Single
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
---|---|
Experimental: Home-based pulmonary rehabilitation
Home visit plus 8 weeks of once-weekly telephone calls
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One home visit plus weekly telephone calls for 8 weeks
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Aktiver Komparator: Hospital-based pulmonary rehabilitation
Standard twice-weekly 8-week outpatient pulmonary rehabilitation program
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Standard twice-weekly 8-week outpatient pulmonary rehabilitation program
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Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
---|---|---|
Change in 6-minute walk test
Zeitfenster: Baseline, 8 weeks and 12 months
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Testing equivalence between groups
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Baseline, 8 weeks and 12 months
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Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
---|---|---|
Change in Chronic Respiratory Disease Questionnaire
Zeitfenster: Baseline, 8 weeks and 12 months
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Baseline, 8 weeks and 12 months
|
|
Change in Modified Medical Research Council Scale
Zeitfenster: Baseline, 8 weeks and 12 months
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Baseline, 8 weeks and 12 months
|
|
Kosteneffektivität
Zeitfenster: 12 Monate
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12 Monate
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SF-36 v2
Zeitfenster: Baseline, 8 weeks and 12 months
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Contributes to cost effectiveness analysis
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Baseline, 8 weeks and 12 months
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Program completion rate
Zeitfenster: 8 weeks
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8 weeks
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Mitarbeiter und Ermittler
Sponsor
Ermittler
- Hauptermittler: Anne E Holland, PhD, La Trobe University, Alfred Health, Institute for Breathing and Sleep
- Hauptermittler: Christine F McDonald, PhD, Austin Health, Institute for Breathing and Sleep
- Hauptermittler: Ajay Mahal, PhD, Monash University
Publikationen und hilfreiche Links
Allgemeine Veröffentlichungen
- 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.
- Grimwood CL, Holland AE, McDonald CF, Mahal A, Hill CJ, Lee AL, Cox NS, Moore R, Nicolson C, O'Halloran P, Lahham A, Gillies R, Burge AT. Comparison of self-report and administrative data sources to capture health care resource use in people with chronic obstructive pulmonary disease following pulmonary rehabilitation. BMC Health Serv Res. 2020 Nov 23;20(1):1061. doi: 10.1186/s12913-020-05920-0.
- Burge AT, Holland AE, McDonald CF, Abramson MJ, Hill CJ, Lee AL, Cox NS, Moore R, Nicolson C, O'Halloran P, Lahham A, Gillies R, Mahal A. Home-based pulmonary rehabilitation for COPD using minimal resources: An economic analysis. Respirology. 2020 Feb;25(2):183-190. doi: 10.1111/resp.13667. Epub 2019 Aug 16.
- Hoaas H, Zanaboni P, Hjalmarsen A, Morseth B, Dinesen B, Burge AT, Cox NS, Holland AE. Seasonal variations in objectively assessed physical activity among people with COPD in two Nordic countries and Australia: a cross-sectional study. Int J Chron Obstruct Pulmon Dis. 2019 Jun 5;14:1219-1228. doi: 10.2147/COPD.S194622. eCollection 2019.
- Lahham A, McDonald CF, Mahal A, Lee AL, Hill CJ, Burge AT, Cox NS, Moore R, Nicolson C, O'Halloran P, Gillies R, Holland AE. Participation in Physical Activity During Center and Home-Based Pulmonary Rehabilitation for People With COPD: A SECONDARY ANALYSIS OF A RANDOMIZED CONTROLLED TRIAL. J Cardiopulm Rehabil Prev. 2019 Mar;39(2):E1-E4. doi: 10.1097/HCR.0000000000000373.
- Liacos A, McDonald CF, Mahal A, Hill CJ, Lee AL, Burge AT, Moore R, Nicolson C, O'Halloran P, Cox NS, Lahham A, Gillies R, Holland AE. The Pulmonary Rehabilitation Adapted Index of Self-Efficacy (PRAISE) tool predicts reduction in sedentary time following pulmonary rehabilitation in people with chronic obstructive pulmonary disease (COPD). Physiotherapy. 2019 Mar;105(1):90-97. doi: 10.1016/j.physio.2018.07.009. Epub 2018 Aug 3.
- Holland AE, Mahal A, Hill CJ, Lee AL, Burge AT, Cox NS, Moore R, Nicolson C, O'Halloran P, Lahham A, Gillies R, McDonald CF. Home-based rehabilitation for COPD using minimal resources: a randomised, controlled equivalence trial. Thorax. 2017 Jan;72(1):57-65. doi: 10.1136/thoraxjnl-2016-208514. Epub 2016 Sep 26.
- Holland AE, Mahal A, Hill CJ, Lee AL, Burge AT, Moore R, Nicolson C, O'Halloran P, Cox NS, Lahham A, Ndongo R, Bell E, McDonald CF. Benefits and costs of home-based pulmonary rehabilitation in chronic obstructive pulmonary disease - a multi-centre randomised controlled equivalence trial. BMC Pulm Med. 2013 Sep 8;13:57. doi: 10.1186/1471-2466-13-57.
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn
Primärer Abschluss (Tatsächlich)
Studienabschluss (Tatsächlich)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Schätzen)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- HomeBase
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