Clinical trial NCT03069716: A Mobile Health Intervention in Pulmonary Arterial Hypertension
Official title: A Mobile Health Intervention in Pulmonary Arterial Hypertension
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pulmonary Arterial Hypertension
Idiopathic Pulmonary Arterial Hypertension
Heritable Pulmonary Arterial Hypertension
Associated Pulmonary Arterial Hypertension
Keywords: Pulmonary Arterial Hypertension
Lead sponsor: Vanderbilt University Medical Center
Sponsor class: OTHER
Collaborators: name: Johns Hopkins University
First posted: 2017-03-03
Enrollment: 49
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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

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.

Eligibility criteria: 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).

Primary outcomes:
measure: Daily Step Count
timeFrame: Baseline to 12 weeks
Secondary outcomes:
measure: Six Minute Walk Test Distance
timeFrame: Baseline to 12 weeks
measure: Right Ventricle (RV) Strain
timeFrame: Baseline to 12 weeks
measure: Percentage of Days Participants Met Their Daily Step Count Goal
timeFrame: Baseline to 12 weeks
measure: Daily Aerobic Time
timeFrame: Baseline to 12 weeks
measure: Change From Baseline at Week 12 in emPHasis-10 Questionnaire Score
timeFrame: Baseline to 12 weeks
measure: Change From Baseline on the SF-36 Mental Component Summary (MCS) Score
timeFrame: Baseline to 12 weeks
measure: Change From Baseline to Week 12 in Borg Dyspnea Score
timeFrame: Baseline to 12 weeks
measure: Resting Heart Rate
timeFrame: Baseline to 12 weeks
measure: Total Lean Mass
timeFrame: Baseline to 12 weeks
measure: Insulin Resistance
timeFrame: Baseline to 12 weeks
measure: BNP
timeFrame: Baseline to 12 weeks
measure: Change From Baseline on the SF-36 Physical Component Summary (PCS) Score
timeFrame: Baseline to 12 weeks
measure: Minutes of Moderate-vigorous Activity
timeFrame: Baseline to 12 Weeks
measure: Visceral Fat Volume
timeFrame: Baseline to Week 12
Other outcomes:
Locations:
city: Nashville
country: United States
facility: Vanderbilt University Medical Center
state: Tennessee
Study officials:
affiliation: Vanderbilt University Medical Center
name: Evan Brittain, MD, MSc
role: PRINCIPAL_INVESTIGATOR
References:
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citation: Pugh ME, Buchowski MS, Robbins IM, Newman JH, Hemnes AR. Physical activity limitation as measured by accelerometry in pulmonary arterial hypertension. Chest. 2012 Dec;142(6):1391-1398. doi: 10.1378/chest.12-0150.
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citation: Mereles D, Ehlken N, Kreuscher S, Ghofrani S, Hoeper MM, Halank M, Meyer FJ, Karger G, Buss J, Juenger J, Holzapfel N, Opitz C, Winkler J, Herth FF, Wilkens H, Katus HA, Olschewski H, Grunig E. Exercise and respiratory training improve exercise capacity and quality of life in patients with severe chronic pulmonary hypertension. Circulation. 2006 Oct 3;114(14):1482-9. doi: 10.1161/CIRCULATIONAHA.106.618397. Epub 2006 Sep 18.
citation: Hemnes AR, Silverman-Lloyd LG, Huang S, MacKinnon G, Annis J, Whitmore CS, Mallugari R, Oggs RN, Hekmat R, Shan R, Huynh PP, Yu C, Martin SS, Blaha MJ, Brittain EL. A Mobile Health Intervention to Increase Physical Activity in Pulmonary Arterial Hypertension. Chest. 2021 Sep;160(3):1042-1052. doi: 10.1016/j.chest.2021.04.012. Epub 2021 Apr 17.