Home Pulmonary Rehabilitation for COPD

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.

Study Overview

• Status: Completed
• Conditions: Emphysema; Chronic Obstructive Pulmonary Disease (COPD)
• Intervention / Treatment: Behavioral: Home Based Pulmonary Rehabilitation

Detailed Description

This study will test the effectiveness of a home-base pulmonary rehabilitation program, that includes off-the-shelf technology (Android computer tablet, Nonin pulse oximeter and Garmin Fitness Tracker), health coaching and an online platform that allows a health coach to review patient monitoring and progress. The comparison will be a wait-list control group.

• Study Type: Interventional
• Enrollment (Actual): 375
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Florida
    • Jacksonville, Florida, United States, 32224
      • Mayo Clinic in Florida
  • Minnesota
    • Minneapolis, Minnesota, United States, 55122
      • Health Partners
    • Rochester, Minnesota, United States, 55905
      • Mayo Clinic in Rochester

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 99 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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/

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Pulmonary Rehabilitation Program Intervention; Subjects will receive 12 weeks home pulmonary rehabilitation (PR) with health coaching.	Behavioral: Home Based Pulmonary Rehabilitation; Twice daily exercise routine six days a week of 3 minutes of personal breathing, 5 exercises with 10 reps each, and 6 minutes of walking with weekly health coach calls.
No Intervention: Usual Care; Subjects will receive 12 weeks of usual care.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Quality of Life	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.	Baseline, 3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Self-management Abilities	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.	Baseline, 3 months
Change in Physical Activity	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 .	Baseline, 3 months
Change in Daily Step Counts	Measured by the Actigraph wGT3X-BT worn for 7 days continuously to measure daily step count.	Baseline, 3 months
Change in Depression	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.	Baseline, 3 months
Social Support	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.	Baseline, 3 months
Meaning in Life	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.	Baseline, 3 months
Change in Sleep Quality	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.	Baseline, 3 months
Change in Anxiety	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.	Baseline, 3 months
Healthcare Utilization	Number of subjects to have an emergency room visits or hospitalization.	3 months

Collaborators and Investigators

• Sponsor: Mayo Clinic
• Collaborators: National Heart, Lung, and Blood Institute (NHLBI)
• Investigators: Principal Investigator: Roberto P Benzo, Mayo Clinic

Publications and helpful links

General Publications

• 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.

Helpful Links

• Mayo Clinic Clinical Trials

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2019
• Primary Completion (Actual): February 16, 2022
• Study Completion (Actual): February 16, 2022

Study Registration Dates

• First Submitted: February 26, 2018
• First Submitted That Met QC Criteria: March 20, 2018
• First Posted (Actual): March 29, 2018

Study Record Updates

• Last Update Posted (Estimated): February 13, 2024
• Last Update Submitted That Met QC Criteria: January 18, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Keywords: Pulmonary Rehabilitation
• Additional Relevant MeSH Terms: Pathologic Processes; Respiratory Tract Diseases; Lung Diseases; Disease Attributes; Chronic Disease; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive; Emphysema
• Other Study ID Numbers: 17-009449; R01HL140486-01 (U.S. NIH Grant/Contract)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No