Clinical trial NCT03480386: Home Pulmonary Rehabilitation for COPD
Official title: Home Pulmonary Rehabilitation for COPD
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Obstructive Pulmonary Disease (COPD)
Emphysema
Keywords: Pulmonary Rehabilitation
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
Collaborators: name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 2018-03-29
Enrollment: 375
Sex: ALL
Minimum age (years): 40
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomization will be stratified by whether the participant has poor lung function (forced expiratory volume \[FEV1\] \<50% predicted) and whether the participant has severe dyspnea (recorded modified Medical Research Council Dyspnea Scale \[mMRC\] score, 3-4; scale, 0-4); critical factors that can make the study arms unbalanced regarding risk factors.
Primary purpose: SUPPORTIVE_CARE

Brief summary: Regular physical activity has been found to be important in maintaining health and well-being in people with COPD. The purpose of this study is to test new technology and health coaching aimed to help people with COPD become more physically active in their daily lives.


Eligibility criteria: Inclusion Criteria:

* Clinical diagnosis of COPD, confirmed by spirometry
* Age ≥40 years (to avoid recruiting participants with asthma rather than COPD)
* Current or previous smoker (≥10 packs per year)
* Confidence in using the proposed pulmonary rehabilitation (PR) system
* English language fluency

Exclusion Criteria:

* Study candidate experiencing an acute COPD exacerbation (can be included after the acute event)
* Inability to walk (orthopedic-neurologic problems or confined to a bed)
* Currently in PR or finished PR in the last three months (unlikely to improve)
* Pregnant women
* Live in an area where cell phones do not work/

Primary outcomes:
measure: Change in Quality of Life
timeFrame: Baseline, 3 months
Secondary outcomes:
measure: Change in Self-management Abilities
timeFrame: Baseline, 3 months
measure: Change in Physical Activity
timeFrame: Baseline, 3 months
measure: Change in Daily Step Counts
timeFrame: Baseline, 3 months
measure: Change in Depression
timeFrame: Baseline, 3 months
measure: Social Support
timeFrame: Baseline, 3 months
measure: Meaning in Life
timeFrame: Baseline, 3 months
measure: Change in Sleep Quality
timeFrame: Baseline, 3 months
measure: Change in Anxiety
timeFrame: Baseline, 3 months
measure: Healthcare Utilization
timeFrame: 3 months
Other outcomes:
Locations:
city: Jacksonville
country: United States
facility: Mayo Clinic in Florida
state: Florida
city: Minneapolis
country: United States
facility: Health Partners
state: Minnesota
city: Rochester
country: United States
facility: Mayo Clinic in Rochester
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Roberto P Benzo
role: PRINCIPAL_INVESTIGATOR
References:
citation: Benzo R, Hoult J, McEvoy C, Clark M, Benzo M, Johnson M, Novotny P. Promoting Chronic Obstructive Pulmonary Disease Wellness through Remote Monitoring and Health Coaching: A Clinical Trial. Ann Am Thorac Soc. 2022 Nov;19(11):1808-1817. doi: 10.1513/AnnalsATS.202203-214OC.