Activity Monitoring in Pulmonary Hypertension

Study Overview
=================
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.

Official Title
-----------------
Activity Monitoring in Pulmonary Hypertension

Conditions
-----------------
Pulmonary Hypertension

Intervention / Treatment
-----------------
* Behavioral: Activity Monitoring


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Participants with Pulmonary Hypertension<br>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<br>* Monitoring with FitBit<br>|
| Healthy Volunteers<br>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<br>* Monitoring with FitBit<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Activity Monitoring | Participants will wear an accelerometer to record activity level | Baseline | 
| Activity Monitoring | Participants will wear an accelerometer to record activity level | 1 year | 
| Activity Monitoring | Participants will wear an accelerometer to record activity level | 2 year | 
| Activity Monitoring | Participants will wear an accelerometer to record activity level | 3 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Six Minute Walk Distance (6MWD) Test | Six Minute Walk Distance Test | Baseline, 1 year, 2 year, 3 year | 
| Intensity of Activity | Intensity of activity is categorized as rest, light, moderate, and vigorous based on calculated metabolic equivalents. | Baseline, 1 year, 2 year, 3 year | 
| Quality of Life 36-Item Short Form Survey (SF-36) | 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. | Baseline, 1 year, 2 year, 3 year | 
| emPHasis-10 | 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. | Baseline, 1 year, 2 year, 3 year | 
| Minnesota Living with Heart Failure (MLHF) | 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. | Baseline, 1 year, 2 year, 3 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Pulmonary Hypertension