Activity Monitoring in Pulmonary Hypertension

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

Study Description

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.

Study Design

• 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

Groups and Cohorts

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

Outcome Measures

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.

Eligibility Criteria

• 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

Contacts and Locations

Contacts

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

Locations

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

• Principal Investigator: Evan L Brittain, MD; Vanderbilt University Medical Center

More Information

• 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
• 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

• 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:

Hypertension, Pulmonary; Hypertension; Vascular Diseases; Cardiovascular Diseases; Lung Diseases; Respiratory Tract Diseases