Pulmonary Hypertension
Conditions
Keywords
Pulmonary Hypertension
Brief summary
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.
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.
Interventions
BEHAVIORALActivity Monitoring
Monitoring with FitBit
Sponsors
Vanderbilt University Medical Center
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Activity Monitoring | Baseline | Participants will wear an accelerometer to record activity level |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Six Minute Walk Distance (6MWD) Test | Baseline, 1 year, 2 year, 3 year | Six Minute Walk Distance Test |
| Intensity of Activity | Baseline, 1 year, 2 year, 3 year | Intensity of activity is categorized as rest, light, moderate, and vigorous based on calculated metabolic equivalents. |
| Quality of Life 36-Item Short Form Survey (SF-36) | Baseline, 1 year, 2 year, 3 year | Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e., a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability. |
| emPHasis-10 | Baseline, 1 year, 2 year, 3 year | The emPHasis-10 is a pulmonary hypertension-specific questionnaire to assess health related quality of life. It covers breathlessness, fatigue and lack of energy, social restrictions, and concerns regarding effects on patient's significant others, such as family and friends. Each item is scored on a semantic differential six-point scale (0-5), with contrasting adjectives at each end. A total emPHasis-10 score is derived using simple aggregation of the 10 items. emPHasis-10 scores range from 0 to 50, higher scores indicating worse quality of life. |
| Minnesota Living with Heart Failure (MLHF) | Baseline, 1 year, 2 year, 3 year | The MLHFQ is one of the most widely used health-related quality of life questionnaires for patients with heart failure. It provides scores for two dimensions, physical and emotional, and a total score. It is a reliable and valid patient-oriented measure of the adverse effects of heart failure on a patient's life. The score can range from 0-126 with 0 being minimal impact and 126 being high impact. |
Countries
United States
Outcome results
None listed