Clinical Trial: A Mobile Health Intervention in Pulmonary Arterial Hypertension

Study Status: Not yet recruiting
Recruit Status: Not yet recruiting
Study Type: Interventional

Official Title: A Mobile Health Intervention in Pulmonary Arterial Hypertension

Brief Summary: This study proposes the use of a mobile health intervention (utilizing a smart phone app) to encourage increased exercise in PAH patients. The study will be a randomized trial to examine feasibility of an mHealth (mobile device) Fitbit Charge HR and cell phone application intervention to improve step counts and increase participants activity level as compared to no intervention. The Fitbit Charge Heart Rate (HR) monitors activity and the cell phone application provides encouragement notifications to half the subjects while the other half do not receive encouragements.

Detailed Summary:

Patients with pulmonary arterial hypertension (PAH) have severely reduced exercise capacity and reduced quality of life. At diagnosis, most PAH patients are New York Heart Association (NYHA) functional class III with symptoms of fatigue and shortness of breath with less than ordinary activity. Physical activity confers multiple benefits relevant to PAH pathophysiology including improvements in endothelial function, energy metabolism, and right ventricular (RV) function. Increasing physical activity is highly efficacious in PAH, resulting in six-minute walk distance (6MWD) improvement that exceeds the effect of medications.

The goal of this proposal is to adapt and test the feasibility of our mHealth intervention to increase physical activity in a geographically diverse PAH population. In secondary aims, we will assess conventional PAH trial outcomes (6MWD, quality of life) and physiologic mechanisms by which increasing activity may improve exercise capacity.

The investigator hypothesizes that an mHealth intervention is feasible and will increase physical activity in subjects with PAH. This study proposes a randomized trial of unblinded step tracking with smart texts tracking for 12 weeks. Participants will wear a display-free triaxial accelerometer, which will continuously transmit data to a compatible smartphone (owned by 75% of our PAH population). Efficacy endpoints have been selected to mirror FDA criteria for drug approval in PAH. The following aims will be tested:

Aim 1: To test the feasibility of an mHealth intervention to increase step counts in patients with PAH. Fifty PAH patients will be randomized to the mHealth intervention or usual activity for 12 weeks. The primary endpoint will be daily step count during Week 12. Secondary endpoints will assess step target a
Sponsor: Vanderbilt University Medical Center

Current Primary Outcome:

• Daily Step Count [ Time Frame: 12 weeks ]
  Change from baseline mean daily step count at week 12. Target feasibility.
• Six Minute Walk Test Distance [ Time Frame: 12 weeks ]
  Change from baseline of six minute walk test distance (meters) at week 12. Target exercise capacity.
• RV Strain [ Time Frame: 12 weeks ]
  Change from baseline of RV free wall longitudinal strain at week 12. Data obtained through transthoracic echocardiography (non-invasive). Target mechanism of improved exercise capacity.

Original Primary Outcome: Same as current

Current Secondary Outcome:

• Daily Goal Attainment [ Time Frame: 12 weeks ]
  Assess the frequency that the daily step target was achieved over time. Daily step targets will increase in increments of 20% every 4 weeks. An increment of 20% was selected because it reflects the average increase in treadmill workload achieved over 4 weeks in chronic obstructive lung disease patients with Pulmonary Hypertension (PH) who attend pulmonary rehabilitation at our facility. Targets feasibility.
• Daily Aerobic Time [ Time Frame: 12 weeks ]
  Aerobic time is defined as total time spent walking continuously for > 10 minutes without breaking for > 1 minute. Targets feasibility.
• Fidelity of Data/Text Transmission (Days) [ Time Frame: 12 weeks ]
  Defined as percent days with incomplete activity data. Targets feasibility.
• Fidelity of Data/Text Transmission (Weeks) [ Time Frame: 12 weeks ]
  Defined as percent weeks with at least 6 days of activity data.Targets feasibility.
• Fidelity of Data/Text Transmission (Total Texts) [ Time Frame: 12 weeks ]
  Defined as percent total texts successfully delivered. Targets feasibility.
• Quality of Life (emPHasis-10) [ Time Frame: 12 weeks ]

  The emPHasis-10 is a short questionnaire that assesses the impact of pulmonary hypertension on assessing 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

  Completed at baseline and week 12 visits.

• Quality of Life (SF-36) [ Time Frame: 12 weeks ]

  The SF-36 survey is a generic, multi-item scale with eight domains that include: physical functioning, bodily pain, mental health, social functioning, vitality, general health perceptions, role limitations-physical, and role limitations-emotional.

  Completed at baseline and week 12 visits.

• Borg Dyspnea Score [ Time Frame: 12 weeks ]
  A measure of the physical activity intensity level based on the subject's perceived exertion. Subjects will rate at resting and peak exercise. Change in baseline score at week 12. Targets exercise capacity.
• Resting Heart Rate [ Time Frame: 12 weeks ]
  Monitored regularly using activity tracking device (per second when active, per 5 seconds when inactive). Subject's resting and peak exercise heart rate will also be recorded at baseline and week 12. Targets exercise capacity.
• Skeletal Muscle Mass [ Time Frame: 12 weeks ]
  Change from baseline skeletal muscle mass at week 12. Body composition will be examined using dual x-ray absorptiometry to assess for changes in relative lean muscle.Targets mechanism of improved exercise capacity.
• HOMA-IR [ Time Frame: 12 weeks ]
  Change from baseline insulin resistance at week 12. Insulin resistance will be quantified using the homeostatic model assessment of insulin resistance (HOMA-IR), which estimates insulin resistance through fasting plasma insulin and glucose ratios.Targets mechanism of improved exercise capacity.
• BNP [ Time Frame: 12 weeks ]
  Change from baseline B-type natriuretic peptide (BNP) level at week 12. BNP is a marker of myocardial stress which decreases with exercise training. Targets mechanism of improved exercise capacity.

Original Secondary Outcome:

• Daily Goal Attainment [ Time Frame: 12 weeks ]
  Assess the frequency that the daily step target was achieved over time. Daily step targets will increase in increments of 20% every 4 weeks. An increment of 20% was selected because it reflects the average increase in treadmill workload achieved over 4 weeks in chronic obstructive lung disease patients with PH who attend pulmonary rehabilitation at our facility. Targets feasibility.
• Daily Aerobic Time [ Time Frame: 12 weeks ]
  Aerobic time is defined as total time spent walking continuously for > 10 minutes without breaking for > 1 minute. Targets feasibility.
• Fidelity of Data/Text Transmission (Days) [ Time Frame: 12 weeks ]
  Defined as percent days with incomplete activity data. Targets feasibility.
• Fidelity of Data/Text Transmission (Weeks) [ Time Frame: 12 weeks ]
  Defined as percent weeks with at least 6 days of activity data.Targets feasibility.
• Fidelity of Data/Text Transmission (Total Texts) [ Time Frame: 12 weeks ]
  Defined as percent total texts successfully delivered. Targets feasibility.
• Quality of Life (emPHasis-10) [ Time Frame: 12 weeks ]

  The emPHasis-10 is a short questionnaire that assesses the impact of pulmonary hypertension on assessing 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

  Completed at baseline and week 12 visits.

• Quality of Life (SF-36) [ Time Frame: 12 weeks ]

  The SF-36 survey is a generic, multi-item scale with eight domains that include: physical functioning, bodily pain, mental health, social functioning, vitality, general health perceptions, role limitations-physical, and role limitations-emotional.

  Completed at baseline and week 12 visits.

• Borg Dyspnea Score [ Time Frame: 12 weeks ]
  A measure of the physical activity intensity level based on the subject's perceived exertion. Subjects will rate at resting and peak exercise. Change in baseline score at week 12. Targets exercise capacity.
• Resting Heart Rate [ Time Frame: 12 weeks ]
  Monitored regularly using activity tracking device (per second when active, per 5 seconds when inactive). Subject's resting and peak exercise heart rate will also be recorded at baseline and week 12. Targets exercise capacity.
• Skeletal Muscle Mass [ Time Frame: 12 weeks ]
  Change from baseline skeletal muscle mass at week 12. Body composition will be examined using dual x-ray absorptiometry to assess for changes in relative lean muscle.Targets mechanism of improved exercise capacity.
• HOMA-IR [ Time Frame: 12 weeks ]
  Change from baseline insulin resistance at week 12. Insulin resistance will be quantified using the homeostatic model assessment of insulin resistance (HOMA-IR), which estimates insulin resistance through fasting plasma insulin and glucose ratios.Targets mechanism of improved exercise capacity.
• BNP [ Time Frame: 12 weeks ]
  Change from baseline B-type natriuretic peptide (BNP) level at week 12. BNP is a marker of myocardial stress which decreases with exercise training. Targets mechanism of improved exercise capacity.

Dates:
Date Received: February 21, 2017
Date Started: June 1, 2017
Date Completion: February 2020
Last Updated: May 12, 2017
Last Verified: May 2017