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Clinical Trials/NCT03480386
NCT03480386
Completed
Not Applicable

Home Pulmonary Rehabilitation for COPD

Mayo Clinic3 sites in 1 country375 target enrollmentJanuary 1, 2019

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Chronic Obstructive Pulmonary Disease (COPD)
Sponsor
Mayo Clinic
Enrollment
375
Locations
3
Primary Endpoint
Change in Quality of Life
Status
Completed
Last Updated
2 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
January 1, 2019
End Date
February 16, 2022
Last Updated
2 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Roberto P. Benzo

Principal Investigator

Mayo Clinic

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/

Outcomes

Primary Outcomes

Change in Quality of Life

Time Frame: Baseline, 3 months

The Chronic Respiratory Questionnaire (CRQ) is a validated tool, completed by participants at baseline and 3 months and measured health-related quality of life. This questionnaire measures both physical and emotional aspects of chronic respiratory disease. All scores have a range of 1 to 7, a higher number being better health-related quality of life. We reported the difference between baseline and 3 months on the CRQ emotional summary score (comprised of the mastery and emotional domains) and the physical summary score (comprised of dyspnea and fatigue domains). 0.5 points is the minimal clinically important difference for this tool.

Secondary Outcomes

  • Healthcare Utilization(3 months)
  • Change in Self-management Abilities(Baseline, 3 months)
  • Change in Physical Activity(Baseline, 3 months)
  • Meaning in Life(Baseline, 3 months)
  • Change in Anxiety(Baseline, 3 months)
  • Social Support(Baseline, 3 months)
  • Change in Sleep Quality(Baseline, 3 months)
  • Change in Daily Step Counts(Baseline, 3 months)
  • Change in Depression(Baseline, 3 months)

Study Sites (3)

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