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

Sally L Wootton; Marita T Dale; Jennifer A Alison; Sarah Brown; Hannah Rutherford; Andrew S L Chan; Marlien Varnfield; Ian A Yang; Michelle Cunich; Sarah Dennis; Zoe J McKeough

doi:10.1093/ptj/pzad044

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

Phys Ther. 2023 Jul 1;103(7):pzad044. doi: 10.1093/ptj/pzad044.

Authors

Sally L Wootton^{1

2}, Marita T Dale², Jennifer A Alison^{2

3}, Sarah Brown^{1

2

4}, Hannah Rutherford^{2

5}, Andrew S L Chan^{1

6

7}, Marlien Varnfield⁸, Ian A Yang⁹, Michelle Cunich^{10

11

12

13

14}, Sarah Dennis^{2

15

16}, Zoe J McKeough²

Affiliations

¹ Chronic Disease Community Rehabilitation Service, Northern Sydney Local Health District, North Ryde, NSW, Australia.
² Faculty of Medicine and Health, Sydney School of Health Sciences, University of Sydney, Sydney, NSW, Australia.
³ Allied Health, Sydney Local Health District, NSW, Australia.
⁴ Department of Physiotherapy, Royal North Shore Hospital, St Leonards, NSW, Australia.
⁵ Directorate of Strategy, Innovation and Improvement, South Eastern Sydney Local Health District, Sydney, NSW, Australia.
⁶ Department of Respiratory and Sleep Medicine, Royal North Shore Hospital, St Leonards, NSW, Australia.
⁷ Faculty of Medicine and Health, Northern Clinical School, The University of Sydney, Sydney, NSW, Australia.
⁸ Australian eHealth Research Centre, CSIRO, Brisbane, Queensland, Australia.
⁹ The Prince Charles Hospital and The University of Queensland, Brisbane, Queensland, Australia.
¹⁰ Boden Initiative, Charles Perkins Centre, Central Clinical School, Faculty of Medicine and Health, The University of Sydney, Camperdown, NSW, Australia.
¹¹ Implementation and Policy, Cardiovascular Initiative, The University of Sydney, Camperdown, NSW, Australia.
¹² Sydney Institute for Women, Children and their Families, Sydney Local Health District , Camperdown, NSW, Australia.
¹³ The ANZAC Research Institute, Concord Repatriation General Hospital, Concord, Australia.
¹⁴ Sydney Health Economics Collaborative, Sydney Local Health District, Sydney, NSW, Australia.
¹⁵ South West Sydney Allied Health Research Collaboration, South West Sydney Local Health District, Liverpool, NSW, Australia.
¹⁶ Ingham Institute for Applied Medical Research, Liverpool, NSW, Australia.

Abstract

Objective: 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.

Methods: 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.

Impact: 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.

Keywords: Chronic Obstructive Pulmonary Disease; Exercise; Physical Activity; Pulmonary Rehabilitation; Quality of Life; mHealth.

Publication types

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

MeSH terms

Cost-Benefit Analysis
Exercise Tolerance
Health Status
Humans
Multicenter Studies as Topic
Pulmonary Disease, Chronic Obstructive*
Quality of Life
Randomized Controlled Trials as Topic
Telemedicine*