Home Pulmonary Rehabilitation for COPD

Study Overview
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Brief Summary
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While pulmonary rehabilitation provides benefits to people with COPD, only 25% have access to pulmonary rehabilitation each year. The main barriers are related to travel and transportation. This protocol will evaluate the effect of a home-based rehabilitation system on quality of life and steps. The system allows for monitoring by a health care system. A health coach will review the data and provide coaching to facilitate behavioral change and self-efficacy.

Detailed Description
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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.

Official Title
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Home Pulmonary Rehabilitation for COPD

Conditions
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COPD, Emphysema

Intervention / Treatment
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* Behavioral: Home Based Pulmonary Rehabilitation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria Clinical diagnosis of COPD, Age ≥40 years Current or previous smoker (≥10 packs per year) Confidence in using the proposed PR system English or Spanish language fluency Exclusion Criteria Unable or unwilling to do Rehabilitation due to physical conditions

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 99 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention<br>Patients randomized in this arm will start with the home based pulmonary rehabilitation program. | Behavioral: Home Based Pulmonary Rehabilitation<br>* The intervention consists of doing 12 weeks of exercises at home, with a weekly call from a health coach.<br>|
| Active Comparator: Control<br>Patients randomized in this arm will start the intervention after 12 weeks of usual care. | Behavioral: Home Based Pulmonary Rehabilitation<br>* The intervention consists of doing 12 weeks of exercises at home, with a weekly call from a health coach.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Participants on home-based PR will have higher quality of life at month three after randomization than participants in the waitlist control group. | Participants will complete quality of life questionnaires at enrollment and at 3 months. The Chronic Respiratory Questionnaire (CRQ) will be utilized to measure quality of life. The intervention participants will have a change in quality of life. | baseline, 3 months. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Daily Physical Activity will be measured and compared between baseline and three months | Actigraph GT3X is the validated tool to measure physical activity. The Actigraph will be worn for one week to measures sedentary time, daily step, and time in sedentary mode, and mild-moderate and vigorous physical activity. | baseline and 3 months | 
| Self-Management | Self-Management Ability Scale-30 item questionnaire measuring ability and function. A higher score indicates higher function and ability.The SMAS consists of 30 items on four- and five-point Likert scales. Scores on the subscales and the total score are transformed into scores ranging from 0 to 100 (higher number is best). Each question has a range from 1-5. | baseline and 3 months | 
| Depression | Patient Health Questionnaire-9 item questionnaire screening for depression. A higher score indicates that depression may be present. Scores range from 0-27. | baseline and 3 months | 
| Social Support | The MSPSS is a 12-item scale designed to measure perceived social support from three sources: Family, Friends, and a Significant Other.- 12 item questionnaire with a range of 12-84. A higher score indicates a greater amount of social support. | baseline and 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 and 3 month | 
| Sleep Quality | Sleep Quality Assessment - 9 item questionnaire measuring the quality and patterns of sleep. Scores range from 0 to 21. A lower score suggests a better quality of sleep. | baseline and 3 month | 
| Anxiety | General Anxiety Disorder-2 item Questionnaire screening for anxiety. Score ranges from 0-6, a higher score suggests that anxiety is present. | baseline and 3 month | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pulmonary Rehabilitation