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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
| |
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Activity Monitoring | Behavioral | Monitoring with FitBit |
|
| 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 |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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Participants will be those enrolled in the Longitudinal Pulmonary Vascular Disease Phenomics Program (L-PVDOMICS) and any patient with pulmonary hypertension.
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| Name | Affiliation | Role |
|---|---|---|
| Evan L Brittain, MD | Vanderbilt University Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Vanderbilt University Medical Center | Nashville | Tennessee | 37232 | United States |
Use of study data and biospecimens, and resulting findings, during the PVDOMICS study are subject to approval of the PVDOMICS Steering Committee and follow guidelines of the Publications and Ancillary Study Committee. The data and biospecimens from subjects at a clinical center are the property of the PVDOMICS study and are under the custody of that center.
At the end of the PVDOMICS study and this proposal, the data and remaining biospecimens will be transferred to PVDOMICS and/or to the National Heart, Lung and Blood Institute (NHLBI) Biological Specimen and Data Repository Information Coordinating Center (BioLINCC) biobank and become the property of one of these organizations. Future researchers may request data or biospecimens from a biobank with approval following the guidelines of the biobank. Protocols for data sharing after the conclusion of PVDOMICS have not been established, but will be created in accordance with the NIH Data Sharing Policy.
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at the end of the PVDOMICS study
subject to approval of PVDOMICS Steering Committee
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| ID | Term |
|---|---|
| D006976 | Hypertension, Pulmonary |
| ID | Term |
|---|---|
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D006973 | Hypertension |
| D014652 | Vascular Diseases |
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| 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 |
| D002318 |
| Cardiovascular Diseases |