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

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

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.

Study Overview

• Status: Completed
• Conditions: Pulmonary Arterial Hypertension
• Intervention / Treatment: Behavioral: Home Rehabilitation Monitoring System; Behavioral: Health coaching calls

• Study Type: Observational
• Enrollment (Actual): 14

Contacts and Locations

Study Locations

• United States
  • Minnesota
    • Rochester, Minnesota, United States, 55905
      • Mayo Clinic in Rochester

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Subjects identified with the medical diagnoses of Pulmonary Arterial Hypertension (PAH) from the Mayo Clinic in Rochester, MN PH clinic.

Description

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).

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

Home Rehabilitation Monitoring System; 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; 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.; Behavioral: Health coaching calls; 12 telephone-based health coaching calls over a 12-week period

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Mayo Clinic
• Investigators: Principal Investigator: Hilary DuBrock, MD, Mayo Clinic

Publications and helpful links

Helpful Links

• Mayo Clinic Clinical Trials

Study record dates

Study Major Dates

• Study Start (Actual): September 6, 2022
• Primary Completion (Actual): June 30, 2023
• Study Completion (Actual): June 30, 2023

Study Registration Dates

• First Submitted: August 26, 2022
• First Submitted That Met QC Criteria: August 26, 2022
• First Posted (Actual): August 30, 2022

Study Record Updates

• Last Update Posted (Actual): April 22, 2024
• Last Update Submitted That Met QC Criteria: April 18, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Respiratory Tract Diseases; Lung Diseases; Hypertension, Pulmonary; Hypertension; Pulmonary Arterial Hypertension; Familial Primary Pulmonary Hypertension
• Other Study ID Numbers: 22-000414

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

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