Home Pulmonary Rehabilitation for COPD
- Conditions
- Chronic Obstructive Pulmonary Disease (COPD)Emphysema
- Interventions
- Behavioral: Home Based Pulmonary Rehabilitation
- Registration Number
- NCT03480386
- Lead Sponsor
- Mayo Clinic
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 375
- 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
- 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/
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Pulmonary Rehabilitation Program Intervention Home Based Pulmonary Rehabilitation Subjects will receive 12 weeks home pulmonary rehabilitation (PR) with health coaching.
- Primary Outcome Measures
Name Time Method Change in Quality of Life 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 Outcome Measures
Name Time Method Healthcare Utilization 3 months Number of subjects to have an emergency room visits or hospitalization.
Change in Self-management Abilities Baseline, 3 months Measured using the Self-Management Ability Scale-30 item questionnaire to assess ability and function. The SMAS consists of 30 items on four- and five-point Likert scales. Total score ranging from 0 to 100 with higher score indicating a higher function and ability, better outcome.
Change in Physical Activity Baseline, 3 months The change in average daily activity (measured in minutes) for the top 3 to 5 most active days during the measured period. Measured by the Actigraph GT3X .
Meaning in Life Baseline, 3 months Meaning in Life Questionnaire- 10 item questionnaire measuring the purpose, meaning and presence in life. A higher score indicates a perception of higher meaning and purpose. Scores range from 10-70, a higher score indicates a high perceived meaning and purpose in the respondents life.
Change in Anxiety Baseline, 3 months Measured using the General Anxiety Disorder-2 item Questionnaire screening for anxiety. Score ranges from 0 to 6.,A higher score suggests that anxiety is present.
Social Support Baseline, 3 months Measured by the Interpersonal Support Evaluation List (ISEL-12) a 12-item measure of perceptions of social support utilizing three different subscales designed to measure three dimensions of f perceived social support (appraisal support, beloning support, and tangible support). Each dimension is measured by 4 items on a 4-point scale ranging from "Definitely True" to "Definitely False". Total score range 0-36 with a higher score indicating greater social support.
Change in Sleep Quality Baseline, 3 months Measured using the Pittsburgh Sleep Quality Index to assess severity of sleep disturbances. 9 item questionnaire with total possible scores range from 0 to 21. A lower score suggests a better quality of sleep and a higher score indicates a worse outcome/more severe symptoms of disturbance.
Change in Daily Step Counts Baseline, 3 months Measured by the Actigraph wGT3X-BT worn for 7 days continuously to measure daily step count.
Change in Depression Baseline, 3 months Measured by the Patient Health Questionnaire-9 item questionnaire screening for depression. Total score range from 0 to 27. A higher score indicates that depression may be present.
Trial Locations
- Locations (3)
Health Partners
🇺🇸Minneapolis, Minnesota, United States
Mayo Clinic in Florida
🇺🇸Jacksonville, Florida, United States
Mayo Clinic in Rochester
🇺🇸Rochester, Minnesota, United States