Pulmonary Arterial Hypertension
Conditions
Brief summary
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.
Interventions
BEHAVIORALHome Rehabilitation Monitoring System
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.
BEHAVIORALHealth coaching calls
12 telephone-based health coaching calls over a 12-week period
Sponsors
Mayo Clinic
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Adverse Events | 12 weeks | Number of adverse events attributed to home-based pulmonary rehabilitation |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in EmPHasis-10 Quality of Life Survey | Baseline, 3 months | 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. |
| Change in PAH-SYMPACT domain scores Quality of Life | Baseline, 3 months | 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. |
| Change in self-management abilities | Baseline, 3 months | 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. |
| Change in daily physical activity | Baseline, 3 months | Number of daily steps captured by the Home Rehabilitation Monitoring System |
| Change in exercise capacity | Baseline, 3 months | Measured by 6-minute walk exercise captured by the Home Rehabilitation Monitoring System |
Countries
United States
Outcome results
None listed