Activity Monitoring in Pulmonary Hypertension

Purpose

This is a prospective, longitudinal, observational study of free-living activity trackers and patient reported outcomes to test the hypothesis that daily activity will have stronger prognostic value than 6MWD in patients with pulmonary hypertension after 12 weeks.

Condition

  • Pulmonary Hypertension

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Enrolled in L-PVDOMICS or - Any patient in the United States with pulmonary hypertension confirmed by hemodynamics and expert clinical diagnosis

Exclusion Criteria

  • Pregnancy - Hospitalization within the prior 3 months - Orthopedic limitations that preclude 6MWD testing

Study Design

Phase
Study Type
Observational
Observational Model
Case-Only
Time Perspective
Prospective

Arm Groups

ArmDescriptionAssigned Intervention
Participants with Pulmonary Hypertension Participants will undergo activity monitoring for 12 weeks, at baseline and once a year for 3 years. Patient reported outcomes will be collected including Quality of Life questionnaires [emphasis-10, Minnesota Living with Heart Failure (MLHF), and SF-36 surveys], medication changes, hospitalization, and death.
  • Behavioral: Activity Monitoring
    Monitoring with FitBit
Healthy Volunteers Participants will undergo activity monitoring for 12 weeks, at baseline and once a year for 3 years. Patient reported outcomes will be collected including Quality of Life questionnaires [emphasis-10, Minnesota Living with Heart Failure (MLHF), and SF-36 surveys], medication changes, hospitalization, and death.
  • Behavioral: Activity Monitoring
    Monitoring with FitBit

Recruiting Locations

Vanderbilt University Medical Center
Nashville, Tennessee 37232

More Details

Status
Recruiting
Sponsor
Vanderbilt University Medical Center

Study Contact

Alisha Lindsey
937-638-2416
alisha.lindsey@vumc.org

Detailed Description

A prospective, longitudinal, observational study of free-living activity tracking and patient-reported outcomes in patients with pulmonary hypertension. Participants will undergo activity monitoring for 12 weeks once a year for 4 years. Patient-reported outcomes will be collected including quality of life (emphasis-10, Minnesota Living with Heart Failure (MLHF), and SF-36 surveys), medication changes, hospitalization, and death. This study aims to enroll 500 participants. The objectives of this study are to establish the clinical utility of daily activity tracking in patients with pulmonary hypertension and to identify clinical factors associated with reduced daily activity.