- ICH GCP
- Registre américain des essais cliniques
- Essai clinique 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
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Type d'étude
Inscription (Anticipé)
Phase
- Phase 3
Contacts et emplacements
Lieux d'étude
-
-
Victoria
-
Heidelberg, Victoria, Australie, 3084
- Austin Health
-
Melbourne, Victoria, Australie, 3004
- Alfred Health
-
-
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
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
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Seul
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Expérimental: Home-based pulmonary rehabilitation
Home visit plus 8 weeks of once-weekly telephone calls
|
One home visit plus weekly telephone calls for 8 weeks
|
|
Comparateur actif: Hospital-based pulmonary rehabilitation
Standard twice-weekly 8-week outpatient pulmonary rehabilitation program
|
Standard twice-weekly 8-week outpatient pulmonary rehabilitation program
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Change in 6-minute walk test
Délai: Baseline, 8 weeks and 12 months
|
Testing equivalence between groups
|
Baseline, 8 weeks and 12 months
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Change in Chronic Respiratory Disease Questionnaire
Délai: Baseline, 8 weeks and 12 months
|
Baseline, 8 weeks and 12 months
|
|
|
Change in Modified Medical Research Council Scale
Délai: Baseline, 8 weeks and 12 months
|
Baseline, 8 weeks and 12 months
|
|
|
Rentabilité
Délai: 12 mois
|
12 mois
|
|
|
SF-36 v2
Délai: Baseline, 8 weeks and 12 months
|
Contributes to cost effectiveness analysis
|
Baseline, 8 weeks and 12 months
|
|
Program completion rate
Délai: 8 weeks
|
8 weeks
|
Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Chercheur principal: Anne E Holland, PhD, La Trobe University, Alfred Health, Institute for Breathing and Sleep
- Chercheur principal: Christine F McDonald, PhD, Austin Health, Institute for Breathing and Sleep
- Chercheur principal: Ajay Mahal, PhD, Monash University
Publications et liens utiles
Publications générales
- 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.
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Estimation)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- HomeBase
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