A Phase 3 interventional study of Home-based pulmonary rehabilitation and Hospital-based pulmonary rehabilitation in Chronic Obstructive Pulmonary Disease, sponsored by La Trobe University. Completed at 2 sites in Australia. Open to participants aged 40 Years and older. Per ClinicalTrials.gov, last updated 2019-08-14.
Sponsored by La Trobe University · Phase 3, Interventional, and Treatment
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
5,520 studies on the registry are indexed under Pulmonary Disease, Chronic Obstructive; 856 are open to participants now.
This study's planned enrollment of 144 is above the median of 62 across 3,839 interventional studies indexed under Pulmonary Disease, Chronic Obstructive.
Browse Pulmonary Disease, Chronic Obstructive studies →La Trobe University is the lead sponsor of 8 studies on the registry; 3 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
COPD
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Home visit plus 8 weeks of once-weekly telephone calls
Behavioral: Home-based pulmonary rehabilitation
Standard twice-weekly 8-week outpatient pulmonary rehabilitation program
Behavioral: Hospital-based pulmonary rehabilitation
One home visit plus weekly telephone calls for 8 weeks
Standard twice-weekly 8-week outpatient pulmonary rehabilitation program
Change in 6-minute walk test
Testing equivalence between groups
Time frame: Baseline, 8 weeks and 12 months
Change in Chronic Respiratory Disease Questionnaire
Time frame: Baseline, 8 weeks and 12 months
Change in Modified Medical Research Council Scale
Time frame: Baseline, 8 weeks and 12 months
Cost-effectiveness
Time frame: 12 months
SF-36 v2
Contributes to cost effectiveness analysis
Time frame: Baseline, 8 weeks and 12 months
Program completion rate
Time frame: 8 weeks
This study is completed, as verified in Aug 2019. You cannot join it, but the record below documents what was studied.
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Pulmonary Disease, Chronic Obstructive →
La Trobe University