A Mobile Health Intervention in Pulmonary Arterial Hypertension

Not Applicable

Completed

Conditions: Idiopathic Pulmonary Arterial Hypertension
Pulmonary Arterial Hypertension
Heritable Pulmonary Arterial Hypertension
Associated Pulmonary Arterial Hypertension

Interventions: Device: Smartphone Text Messaging
Device: Fitbit Charge HR

Registration Number: NCT03069716

Lead Sponsor: Vanderbilt University Medical Center

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 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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 49

Inclusion Criteria

Aged 18 or older.
Diagnosed with idiopathic, heritable, or associated (connective tissue disease, drugs, or toxins) pulmonary arterial hypertension (PAH) according to World Health Organization consensus recommendations.
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.
Subjects must own a Bluetooth capable modern smartphone capable of receiving and sending text messages and an active data plan.

Exclusion Criteria

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.
Pregnancy.
Diagnosis of PAH etiology other than idiopathic, heritable, or associated.
Forced vital capacity <70% predicted.
Functional class IV heart failure.
Requirement of > 1 diuretic adjustment in the prior three months.
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

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Smartphone Text Messaging	Smartphone Text Messaging	Group receives personalized, health coaching via "smart" text messages.
No Smartphone Text Messaging	Fitbit Charge HR	Group does not receive personalized, health coaching via "smart" text messages.
Smartphone Text Messaging	Fitbit Charge HR	Group receives personalized, health coaching via "smart" text messages.

Primary Outcome Measures

Name	Time	Method
Daily Step Count	Baseline to 12 weeks	Change from baseline mean daily step count at week 12.

Secondary Outcome Measures

Name	Time	Method
Six Minute Walk Test Distance	Baseline to 12 weeks	Change from baseline of six minute walk test distance (meters) at week 12.
Change From Baseline on the SF-36 Mental Component Summary (MCS) Score	Baseline to 12 weeks	SF-36 consists of 36 questions measuring 8 health domains: physical functioning, bodily pain, role limitations due to physical problems, role limitations due to emotional problems, general health perceptions, mental health, social function, and vitality. The patient's responses are solicited using Likert scales that vary in length, with 3-6 response options per item. The SF-36 can be scored into the 8 health domains named above and two overall summary scores: physical component summary (PCS) and mental component summary (MCS) scores. The domain and summary scores range from 0 to 100; higher scores indicate better levels of function and/or better health
Total Lean Mass	Baseline to 12 weeks	Change from baseline lean mass at week 12.
Percentage of Days Participants Met Their Daily Step Count Goal	Baseline to 12 weeks	All participants were provided with an Fitbit Charge Heart Rate mobile device to monitor daily step counts, activity time, and aerobic time. The daily goal was communicated via text to the intervention group and was the baseline step count average for the control group. Increased daily goal attainment indicates increased activity level
Change From Baseline at Week 12 in emPHasis-10 Questionnaire Score	Baseline to 12 weeks	Quality of life was assessed using the emPHasis-10 questionnaire, a disease-specific self-administered 10-question questionnaire designed for routine assessment of health-related quality of life in pulmonary hypertension. Total score can range from 0 to 50, with higher scores indicating a worse quality of life. Change from Baseline was calculated as the value at Week 12 minus the value at Baseline. The Week 12 value was defined as the last assessment at or prior to Week 12.
Right Ventricle (RV) Strain	Baseline to 12 weeks	Change from baseline of RV free wall longitudinal strain at week 12.
Change From Baseline to Week 12 in Borg Dyspnea Score	Baseline to 12 weeks	The Borg Dyspnea score is a self-rating scale to evaluate the severity of dyspnea (from 0 "no shortness of breath at all" to 10 "very, very severe / maximal" shortness of breath). The scale was completed at the beginning and conclusion of each 6-minute walk test at baseline and at Week 12. Median change from baseline in scoring was reported.
Resting Heart Rate	Baseline to 12 weeks	Change in heart rate between Week 12 and Baseline
Minutes of Moderate-vigorous Activity	Baseline to 12 Weeks	Change in minutes between Week 12 and Baseline
Visceral Fat Volume	Baseline to Week 12	Change in fat volume between Week 12 and Baseline
Daily Aerobic Time	Baseline to 12 weeks	Change in minutes of activity per day between Week 12 and Baseline
Insulin Resistance	Baseline to 12 weeks	Insulin resistance measured by the Homeostatic Model Assessment for Insulin Resistance insulin resistance score (HOMA-IR) utilizing the formula: fasting plasma glucose (mmol/l) times fasting serum insulin (mU/l) divided by 22.5. Low HOMA-IR values indicate high insulin sensitivity, whereas high HOMA-IR values indicate low insulin sensitivity (insulin resistance).
BNP	Baseline to 12 weeks	Change from baseline B-type natriuretic peptide level at week 12.
Change From Baseline on the SF-36 Physical Component Summary (PCS) Score	Baseline to 12 weeks	SF-36 consists of 36 questions measuring 8 health domains: physical functioning, bodily pain, role limitations due to physical problems, role limitations due to emotional problems, general health perceptions, mental health, social function, and vitality. The patient's responses are solicited using Likert scales that vary in length, with 3-6 response options per item. The SF-36 can be scored into the 8 health domains named above and two overall summary scores: physical component summary (PCS) and mental component summary (MCS) scores. The domain and summary scores range from 0 to 100; higher scores indicate better levels of function and/or better health