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Activity Monitoring in Pulmonary Hypertension

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ClinicalTrials.gov Identifier: NCT04101630
Recruitment Status : Recruiting
First Posted : September 24, 2019
Last Update Posted : November 25, 2020
Sponsor:
Information provided by (Responsible Party):
Evan Brittain, Vanderbilt University Medical Center

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.

Condition or disease Intervention/treatment
Pulmonary Hypertension Behavioral: Activity Monitoring

Detailed Description:
A prospective, longitudinal, observational study of free-living activity tracking and patient-reported outcomes in participants enrolled in the Longitudinal Pulmonary Vascular Disease Phenomics Program (L-PVDOMICS). 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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Study Type : Observational
Estimated Enrollment : 500 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Activity Monitoring in Pulmonary Hypertension
Actual Study Start Date : October 24, 2019
Estimated Primary Completion Date : June 2023
Estimated Study Completion Date : June 2024

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
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




Primary Outcome Measures :
  1. Activity Monitoring [ Time Frame: Baseline ]
    Participants will wear an accelerometer to record activity level

  2. Activity Monitoring [ Time Frame: 1 year ]
    Participants will wear an accelerometer to record activity level

  3. Activity Monitoring [ Time Frame: 2 year ]
    Participants will wear an accelerometer to record activity level

  4. Activity Monitoring [ Time Frame: 3 year ]
    Participants will wear an accelerometer to record activity level


Secondary Outcome Measures :
  1. Six Minute Walk Distance (6MWD) Test [ Time Frame: Baseline, 1 year, 2 year, 3 year ]
    Six Minute Walk Distance Test

  2. Intensity of Activity [ Time Frame: Baseline, 1 year, 2 year, 3 year ]
    Intensity of activity is categorized as rest, light, moderate, and vigorous based on calculated metabolic equivalents.

  3. Quality of Life 36-Item Short Form Survey (SF-36) [ Time Frame: 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.

  4. emPHasis-10 [ Time Frame: 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.

  5. Minnesota Living with Heart Failure (MLHF) [ Time Frame: 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Participants will be those enrolled in the Longitudinal Pulmonary Vascular Disease Phenomics Program (L-PVDOMICS).
Criteria

Inclusion Criteria:

  • Enrolled in L-PVDOMICS

Exclusion Criteria:

  • Pregnancy
  • Hospitalization within the prior 3 months

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04101630


Contacts
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Contact: Carolyn Whitmore 615-936-1003 carolyn.whitmore@vumc.org

Locations
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United States, Tennessee
Vanderbilt University Medical Center Recruiting
Nashville, Tennessee, United States, 37232
Principal Investigator: Evan L Brittain, MD         
Sponsors and Collaborators
Vanderbilt University Medical Center
Investigators
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Principal Investigator: Evan L Brittain, MD Vanderbilt University Medical Center
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Responsible Party: Evan Brittain, Assistant Professor of Medicine, Vanderbilt University Medical Center
ClinicalTrials.gov Identifier: NCT04101630    
Other Study ID Numbers: Physical Activity in PH
First Posted: September 24, 2019    Key Record Dates
Last Update Posted: November 25, 2020
Last Verified: November 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description:

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.

Time Frame: at the end of the PVDOMICS study
Access Criteria: subject to approval of PVDOMICS Steering Committee

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Evan Brittain, Vanderbilt University Medical Center:
Pulmonary Hypertension
Additional relevant MeSH terms:
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Hypertension, Pulmonary
Hypertension
Vascular Diseases
Cardiovascular Diseases
Lung Diseases
Respiratory Tract Diseases