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Trial record 1 of 1 for:    03069716
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A Mobile Health Intervention in Pulmonary Arterial Hypertension (mHealth)

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ClinicalTrials.gov Identifier: NCT03069716
Recruitment Status : Completed
First Posted : March 3, 2017
Last Update Posted : July 14, 2020
Sponsor:
Collaborator:
Johns Hopkins University
Information provided by (Responsible Party):
Evan Brittain, 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.

Condition or disease Intervention/treatment Phase
Pulmonary Arterial Hypertension Idiopathic Pulmonary Arterial Hypertension Heritable Pulmonary Arterial Hypertension Associated Pulmonary Arterial Hypertension Device: Smartphone Text Messaging Device: Fitbit Charge HR Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 49 participants
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.
Masking: Triple (Care Provider, Investigator, Outcomes Assessor)
Masking Description:

Investigators are blinded.

Study personnel conducting 6MWT and echo will be blinded.

Primary Purpose: Treatment
Official Title: A Mobile Health Intervention in Pulmonary Arterial Hypertension
Actual Study Start Date : August 2, 2017
Actual Primary Completion Date : April 24, 2020
Actual Study Completion Date : April 24, 2020


Arm Intervention/treatment
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 Name: 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 Name: Digital Activity Tracker

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 Name: Digital Activity Tracker




Primary Outcome Measures :
  1. Daily Step Count [ Time Frame: 12 weeks ]
    Change from baseline mean daily step count at week 12. Target feasibility.

  2. 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.

  3. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. Fidelity of Data/Text Transmission (Days) [ Time Frame: 12 weeks ]
    Defined as percent days with incomplete activity data. Targets feasibility.

  4. Fidelity of Data/Text Transmission (Weeks) [ Time Frame: 12 weeks ]
    Defined as percent weeks with at least 6 days of activity data.Targets feasibility.

  5. Fidelity of Data/Text Transmission (Total Texts) [ Time Frame: 12 weeks ]
    Defined as percent total texts successfully delivered. Targets feasibility.

  6. 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.


  7. 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.


  8. 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.

  9. 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.

  10. 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.

  11. 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.

  12. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03069716


Locations
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United States, Tennessee
Vanderbilt University Medical Center
Nashville, Tennessee, United States, 37232
Sponsors and Collaborators
Vanderbilt University Medical Center
Johns Hopkins University
Investigators
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Principal Investigator: Evan Brittain, MD, MSc Vanderbilt University Medical Center
Publications:
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Responsible Party: Evan Brittain, Assistant Professor of Medicine, Vanderbilt University Medical Center
ClinicalTrials.gov Identifier: NCT03069716    
Other Study ID Numbers: IRB #162004
First Posted: March 3, 2017    Key Record Dates
Last Update Posted: July 14, 2020
Last Verified: July 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Evan Brittain, Vanderbilt University Medical Center:
Pulmonary Arterial Hypertension
Additional relevant MeSH terms:
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Familial Primary Pulmonary Hypertension
Hypertension
Vascular Diseases
Cardiovascular Diseases
Hypertension, Pulmonary
Lung Diseases
Respiratory Tract Diseases