A Mobile Health Intervention in Pulmonary Arterial Hypertension

NCT03069716 | Completed Results DMC

• 1 other identifier: IRB #162004
• Study Type: interventional
• Target: 49
• Locations: 1 country
• Sites: 1

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.

Conditions

Pulmonary Arterial Hypertension; Idiopathic Pulmonary Arterial Hypertension; Heritable Pulmonary Arterial Hypertension; Associated Pulmonary Arterial Hypertension

Keywords

Pulmonary Arterial Hypertension

Outcome Measures

Primary Outcomes (1)

• Daily Step Count

  Change from baseline mean daily step count at week 12.

  Baseline to 12 weeks

Secondary Outcomes (14)

• Six Minute Walk Test Distance

  Baseline to 12 weeks

• Right Ventricle (RV) Strain

  Baseline to 12 weeks

• Percentage of Days Participants Met Their Daily Step Count Goal

  Baseline to 12 weeks

• Daily Aerobic Time

  Baseline to 12 weeks

• Change From Baseline at Week 12 in emPHasis-10 Questionnaire Score

  Baseline to 12 weeks

Study Arms (2)

Smartphone Text Messaging

EXPERIMENTAL

Group receives personalized, health coaching via "smart" text messages.

Device: Smartphone Text Messaging; Device: Fitbit Charge HR

No Smartphone Text Messaging

OTHER

Group does not receive personalized, health coaching via "smart" text messages.

Device: Fitbit Charge HR

Interventions

Smartphone Text Messaging DEVICE

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.

Also known as: mHealth activity intervention

Smartphone Text Messaging

Fitbit Charge HR DEVICE

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.

Also known as: Digital Activity Tracker

No Smartphone Text Messaging; Smartphone Text Messaging

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Vanderbilt University Medical Center: lead
• Johns Hopkins University: collaborator

Study Sites (1)

Vanderbilt University Medical Center

Nashville, Tennessee, 37232, United States

Location

Related Publications (5)

• Martin SS, Feldman DI, Blumenthal RS, Jones SR, Post WS, McKibben RA, Michos ED, Ndumele CE, Ratchford EV, Coresh J, Blaha MJ. mActive: A Randomized Clinical Trial of an Automated mHealth Intervention for Physical Activity Promotion. J Am Heart Assoc. 2015 Nov 9;4(11):e002239. doi: 10.1161/JAHA.115.002239.

  PMID: 26553211 BACKGROUND

• 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.

  PMID: 22576635 BACKGROUND

• Bravata DM, Smith-Spangler C, Sundaram V, Gienger AL, Lin N, Lewis R, Stave CD, Olkin I, Sirard JR. Using pedometers to increase physical activity and improve health: a systematic review. JAMA. 2007 Nov 21;298(19):2296-304. doi: 10.1001/jama.298.19.2296.

  PMID: 18029834 BACKGROUND

• 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.

  PMID: 16982941 BACKGROUND

• 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.

  PMID: 33878341 DERIVED

MeSH Terms

Conditions

Pulmonary Arterial Hypertension; Familial Primary Pulmonary Hypertension

Condition Hierarchy (Ancestors)

Hypertension, Pulmonary; Lung Diseases; Respiratory Tract Diseases

Results Point of Contact

• Title: Dr. Evan L. Brittain
• Organization: Vanderbilt University Medical Center

Evan.brittain@vumc.org

(615) 322-4382

Study Officials

• Evan Brittain, MD, MSc

  Vanderbilt University Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Investigators are blinded. Study personnel conducting 6MWT and echo will be blinded.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Medicine

Model Details: 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.

Study Record Dates

• First Submitted: February 21, 2017
• First Posted: March 3, 2017
• Study Start: August 2, 2017
• Primary Completion: April 24, 2020
• Study Completion: April 24, 2020
• Last Updated: June 25, 2021
• Results First Posted: June 24, 2021

Record last verified: 2021-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)