Mobile Health Pulmonary Rehabilitation Compared to a Center-Based Program for Cost-Effectiveness and Effects on Exercise Capacity, Health Status, and Quality of Life in People With Chronic Obstructive Pulmonary Disease: A Protocol for a Randomized Controlled Trial.


Journal

Physical therapy
ISSN: 1538-6724
Titre abrégé: Phys Ther
Pays: United States
ID NLM: 0022623

Informations de publication

Date de publication:
01 07 2023
Historique:
received: 30 11 2022
accepted: 12 02 2023
medline: 7 7 2023
pubmed: 3 5 2023
entrez: 3 5 2023
Statut: ppublish

Résumé

The use of digital health is a novel way to improve access to comprehensive pulmonary rehabilitation for people with chronic obstructive pulmonary disease (COPD). This study aims to determine if a home-based pulmonary rehabilitation program supported by mobile health (mHealth) technology is equivalent to center-based pulmonary rehabilitation in terms of improvements in exercise capacity and health status in people with COPD. This study is a prospective, multicenter, equivalence randomized controlled trial (RCT) with intention-to-treat analysis. A hundred participants with COPD will be recruited from 5 pulmonary rehabilitation programs. Following randomization, participants will be assigned in a concealed manner to receive either home-based pulmonary rehabilitation supported by mHealth or center-based pulmonary rehabilitation. Both programs will be 8 weeks and will include progressive exercise training, disease management education, self-management support, and supervision by a physical therapist. Co-primary outcome measures will be the 6-Minute Walk Test and the COPD Assessment Test. Secondary outcome measures will include the St George's Respiratory Questionnaire, the EuroQol 5 Dimension 5 Level, the modified Medical Research Council dyspnea scale, the 1-minute sit-to-stand test, the 5 times sit-to-stand test, the Hospital Anxiety and Depression Scale, daily physical activity levels, health care utilization, and costs. Outcomes will be measured at baseline and at the end of the intervention. Participant experience will be assessed through semi-structured interviews at the end of the intervention. Utilization of health care and costs will be measured again after 12 months. This study will be the first rigorous RCT to examine the effects of a home-based pulmonary rehabilitation program supported by mHealth technology that includes comprehensive clinical outcome evaluation, assessment of daily physical activity, a health economic analysis, and qualitative analysis. If findings demonstrate that there is equivalence in clinical outcomes, that the mHealth program costs the least amount (and is thus cost-effective), and that the mHealth program is acceptable to participants, such programs should be widely implemented to improve access to pulmonary rehabilitation.

Identifiants

pubmed: 37133445
pii: 7150682
doi: 10.1093/ptj/pzad044
pmc: PMC10321381
pii:
doi:

Types de publication

Clinical Trial Protocol Journal Article Research Support, Non-U.S. Gov't

Langues

eng

Sous-ensembles de citation

IM

Informations de copyright

© The Author(s) 2023. Published by Oxford University Press on behalf of the American Physical Therapy Association.

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Auteurs

Sally L Wootton (SL)

Chronic Disease Community Rehabilitation Service, Northern Sydney Local Health District, North Ryde, NSW, Australia.
Faculty of Medicine and Health, Sydney School of Health Sciences, University of Sydney, Sydney, NSW, Australia.

Marita T Dale (MT)

Faculty of Medicine and Health, Sydney School of Health Sciences, University of Sydney, Sydney, NSW, Australia.

Jennifer A Alison (JA)

Faculty of Medicine and Health, Sydney School of Health Sciences, University of Sydney, Sydney, NSW, Australia.
Allied Health, Sydney Local Health District, NSW, Australia.

Sarah Brown (S)

Chronic Disease Community Rehabilitation Service, Northern Sydney Local Health District, North Ryde, NSW, Australia.
Faculty of Medicine and Health, Sydney School of Health Sciences, University of Sydney, Sydney, NSW, Australia.
Department of Physiotherapy, Royal North Shore Hospital, St Leonards, NSW, Australia.

Hannah Rutherford (H)

Faculty of Medicine and Health, Sydney School of Health Sciences, University of Sydney, Sydney, NSW, Australia.
Directorate of Strategy, Innovation and Improvement, South Eastern Sydney Local Health District, Sydney, NSW, Australia.

Andrew S L Chan (ASL)

Chronic Disease Community Rehabilitation Service, Northern Sydney Local Health District, North Ryde, NSW, Australia.
Department of Respiratory and Sleep Medicine, Royal North Shore Hospital, St Leonards, NSW, Australia.
Faculty of Medicine and Health, Northern Clinical School, The University of Sydney, Sydney, NSW, Australia.

Marlien Varnfield (M)

Australian eHealth Research Centre, CSIRO, Brisbane, Queensland, Australia.

Ian A Yang (IA)

The Prince Charles Hospital and The University of Queensland, Brisbane, Queensland, Australia.

Michelle Cunich (M)

Boden Initiative, Charles Perkins Centre, Central Clinical School, Faculty of Medicine and Health, The University of Sydney, Camperdown, NSW, Australia.
Implementation and Policy, Cardiovascular Initiative, The University of Sydney, Camperdown, NSW, Australia.
Sydney Institute for Women, Children and their Families, Sydney Local Health District , Camperdown, NSW, Australia.
The ANZAC Research Institute, Concord Repatriation General Hospital, Concord, Australia.
Sydney Health Economics Collaborative, Sydney Local Health District, Sydney, NSW, Australia.

Sarah Dennis (S)

Faculty of Medicine and Health, Sydney School of Health Sciences, University of Sydney, Sydney, NSW, Australia.
South West Sydney Allied Health Research Collaboration, South West Sydney Local Health District, Liverpool, NSW, Australia.
Ingham Institute for Applied Medical Research, Liverpool, NSW, Australia.

Zoe J McKeough (ZJ)

Faculty of Medicine and Health, Sydney School of Health Sciences, University of Sydney, Sydney, NSW, Australia.

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