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

Completed

• Conditions: Pulmonary Arterial Hypertension
• Interventions: Behavioral: Home Rehabilitation Monitoring System; Behavioral: Health coaching calls

• Registration Number: NCT05521113
• Lead Sponsor: Mayo Clinic

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.

Detailed Description

Not available

Basic Information
|
Recruitment & Eligibility
|
Study & Design
|
Trial Locations

Study Timeline

• Study First Submitted: 2022-08-26
• Study First Submitted QC: 2022-08-26
• Study First Posted: 2022-08-30
• Study Start: 2022-09-06
• Primary Completion: 2023-06-30
• Study Completion: 2023-06-30
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-18
• Last Update Posted: 2024-04-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 14

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.

Read More

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).

Read More

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Home Rehabilitation Monitoring System	Health coaching calls	Subjects will complete a home pulmonary rehabilitation program while using a home rehabilitation monitoring system and completing health coaching calls.
Home Rehabilitation Monitoring System	Home Rehabilitation Monitoring System	Subjects will complete a home pulmonary rehabilitation program while using a home rehabilitation monitoring system and completing health coaching calls.

Primary Outcome Measures

Name	Time	Method
Adverse Events	12 weeks	Number of adverse events attributed to home-based pulmonary rehabilitation

Secondary Outcome Measures

Name	Time	Method
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 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
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.

Trial Locations

Locations (1)

Mayo Clinic in Rochester; 🇺🇸 Rochester, Minnesota, United States