Home-based Pulmonary Rehabilitation With Remote Monitoring in Pulmonary Arterial Hypertension

Study Overview
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Brief Summary
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The purpose of this study is to test new technology and health coaching aimed to help people with PAH become more physically active in their daily lives.

Official Title
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Feasibility of Home-based Pulmonary Rehabilitation With Remote Monitoring in Pulmonary Arterial Hypertension

Conditions
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Pulmonary Arterial Hypertension

Intervention / Treatment
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* Behavioral: Home Rehabilitation Monitoring System
* Behavioral: Health coaching calls


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Diagnosis of PAH, confirmed by right heart catheterization (mean pulmonary artery pressure of 20 mmHg or greater, pulmonary vascular resistance of 3.0 Woods units or greater, Pulmonary capillary wedge pressure of 15 mmHg or lower). On PAH-specific therapy which is at stable dosing (i.e., not currently titrating therapy). NYHA class II-III symptoms. Able to complete a six-minute walk test. Exclusion Criteria: Patients experiencing syncope or exertional syncope. Patients not experiencing exertional dyspnea. Inability to walk. Patients currently in pulmonary rehab or having completed pulmonary rehab within three months (unlikely to improve).

Ages Eligible for Study
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Minimum Age: 18 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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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Home Rehabilitation Monitoring System<br>Subjects will complete a home pulmonary rehabilitation program while using a home rehabilitation monitoring system and completing health coaching calls. | Behavioral: Home Rehabilitation Monitoring System<br>* The system consists of a small activity monitor worn on the wrist and a pulse oximeter worn on the finger while exercising. Simple exercises will be completed daily and the monitors will send information to a rehabilitation coach during a 12-week period.<br>Behavioral: Health coaching calls<br>* 12 telephone-based health coaching calls over a 12-week period<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse Events | Number of adverse events attributed to home-based pulmonary rehabilitation | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in EmPHasis-10 Quality of Life Survey | Measured using the EmPHasis-10 to determine how pulmonary hypertension affect subject's life. 10-item self-reported questionnaire, total score 0-50 with higher scores indicating worse outcomes or quality of life. | Baseline, 3 months | 
| Change in PAH-SYMPACT domain scores Quality of Life | Measured using the Pulmonary Arterial Hypertension-Symptoms and Impact (PAH-SYMPACT) Questionnaire to assess pulmonary arterial hypertension symptoms over the past 24 hours and 7 days. 23-item self-reported questionnaire, total score 0-89 with higher scores indicating worse outcomes or quality of life. | Baseline, 3 months | 
| Change in self-management abilities | Measured by the Self-Management Ability Scale (SMAS-30) to determine self-management abilities. 30-item self-reported questionnaire, average overall scores 5-30 with higher scores indicating higher self-management abilities. | Baseline, 3 months | 
| Change in daily physical activity | Number of daily steps captured by the Home Rehabilitation Monitoring System | Baseline, 3 months | 
| Change in exercise capacity | Measured by 6-minute walk exercise captured by the Home Rehabilitation Monitoring System | Baseline, 3 months |