Purpose

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.

Conditions

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  1. Aged 18 or older.
  2. Diagnosed with idiopathic, heritable, or associated (connective tissue disease, drugs, or toxins) pulmonary arterial hypertension (PAH) according to World Health Organization consensus recommendations.
  3. Stable PAH-specific medication regimen for three months prior to enrollment. Subjects with only a single diuretic adjustment in the prior three months will be included.
  4. Subjects must own a Bluetooth capable modern smartphone capable of receiving and sending text messages and an active data plan.

Exclusion Criteria

  1. Prohibited from normal activity due to wheelchair bound status, bed bound status, reliance on a cane/walker, activity-limiting angina, activity-limiting osteoarthritis, or other condition.
  2. Pregnancy.
  3. Diagnosis of PAH etiology other than idiopathic, heritable, or associated.
  4. Forced vital capacity <70% predicted.
  5. Functional class IV heart failure.
  6. Requirement of > 1 diuretic adjustment in the prior three months.
  7. Preferred form of activity is not measured by an activity tracker (swimming, yoga, ice skating, stair master, or activities on wheels such as bicycling or rollerblading).

Study Design

Phase
N/A
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Intervention Model Description
Randomization will occur after a two-week run-in period to improve ability to identify a true baseline step count and account for potential dropout. Participants will be assigned to either the smartphone text messaging or no smartphone text messaging arms in a random manner until 25 participants are enrolled into each arm. Permuted block randomization stratified by functional class (I/II vs. III) will be used to ensure approximate balance of treatment groups within each stratum over time. Randomization will be performed in small blocks, which vary in size. Investigators will be unaware of the size or order of the blocks. Randomization will occur through REDCap by a study coordinator. Although the texting intervention will end after Week 12, subjects in both groups will be asked to continue wearing the Fitbit Charge HR device for an additional 3 weeks to determine whether withdrawal of the texting intervention results in a reduction in step counts.
Primary Purpose
Treatment
Masking
Triple (Care Provider, Investigator, Outcomes Assessor)
Masking Description
Investigators are blinded. Study personnel conducting 6MWT and echo will be blinded.

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Smartphone Text Messaging
Group receives personalized, health coaching via "smart" text messages.
  • Device: Smartphone Text Messaging
    A HIPPA compliant text messaging platform is linked to the Fitbit Application Program Interface. Real time activity data will be transmitted from the subject's smartphone to our mHealth platform via cellular network. Subjects will receive 3 texts/day in sync with their preferred morning, lunch, and evening leisure schedule (defined at enrollment). These texts will use personal, disease-specific, and provider information to deliver 2 types of messages customized to the current step count and sent in equal proportion. Messages are designed to facilitate self-awareness, reinforce step targets, and link physical activity with a reward or memorable cue.
    Other names:
    • mHealth activity intervention
  • Device: Fitbit Charge HR
    The Fitbit Charge HR tri-axial accelerometer will be used to continuously gather data on physical activity, heart rate, and sleep. This device provides feedback in units of activity (steps, stairs climbed, activity time, and exercise time) and heart rate (per second when active, per 5 seconds when inactive). It has been validated against research devices in free-living conditions and is relatively inexpensive.
    Other names:
    • Digital Activity Tracker
Other
No Smartphone Text Messaging
Group does not receive personalized, health coaching via "smart" text messages.
  • Device: Fitbit Charge HR
    The Fitbit Charge HR tri-axial accelerometer will be used to continuously gather data on physical activity, heart rate, and sleep. This device provides feedback in units of activity (steps, stairs climbed, activity time, and exercise time) and heart rate (per second when active, per 5 seconds when inactive). It has been validated against research devices in free-living conditions and is relatively inexpensive.
    Other names:
    • Digital Activity Tracker

Recruiting Locations

Vanderbilt University Medical Center
Nashville, Tennessee 37232
Contact:
Rezzan Hekmat, MHS
615-875-8937
rezzan.hekmat.1@vanderbilt.edu

More Details

NCT ID
NCT03069716
Status
Recruiting
Sponsor
Vanderbilt University Medical Center

Study Contact

Rezzan Hekmat, MHS
615-875-8937
rezzan.hekmat.1@vanderbilt.edu

Detailed Description

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 achievement, daily activity time, and aerobic time. The fidelity of data collection and text transmission will also be assessed.

Aim 2: To examine the effect of an mHealth intervention on exercise capacity and quality of life. Participants will complete a six minute walk test and the emPHasis-10 questionnaire at baseline and 12 weeks. The primary endpoint will be six minute walk distance. Secondary endpoints will be emPHasis-10 quality of life scale score, Borg dyspnea score, and resting heart rate.

Aim 3: To examine the effect of an mHealth intervention on mechanisms of improved exercise capacity. Subjects will undergo echocardiography, blood draw, and body composition assessment. The primary endpoint will be RV longitudinal strain. Secondary endpoints will be the homeostatic model assessment of insulin resistance, lean muscle and fat mass, and B-type natriuretic peptide.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.