Utility of At-home Monitoring of Exercise Capacity by App-based 6-minute Walk Test (DynAMITE)

August 7, 2023 updated by: Roham T. Zamanian, Stanford University

Utility of Device and App-based Mobile Health Monitoring as a Tool for Evaluation of Clinical Response to Therapies in Pulmonary Arterial Hypertension

  • Evaluate for accuracy and reproducibility of data collected via the participant-operated Walk.Talk.Track. (WTT) app combined with Apple Watch during in-clinic, technician proctored 6MWT's.

    • Determine whether the WTT app on the Apple Watch can accurately collect information on distance traveled and heart rate (HR) during in-clinic 6MWT run by American Thoracic Society (ATS) guidelines
    • Determine whether participants can operate the WTT app and Apple Watch effectively to gather accurate data in a monitored and home-based setting

  • Prospectively monitor for changes in WTT app recorded 6MWT results following initiation of therapy in a treatment naïve cohort of PAH participants

    • Evaluate whether changes from baseline in 6 minute walk distance (6MWD) and heart rate recovery at one minute (HRR1) as well as other variables that have been associated with disease severity in PAH and left-sided heart disease (resting HR, heart rate variability [HRV], chronotropic index [CI]) can be identified before the 12-week follow up when comparing the treatment arm and the control arm
    • Evaluate whether changes from baseline in the HRR1, resting HR, HRV and/or CI are more evident in treatment responders when compared to treatment non-responders.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

63

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Stanford, California, United States, 94305
        • Stanford University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Diagnosis of WHO Group I Pulmonary Arterial Hypertension (PAH) (Idiopathic (I)PAH, Heritable PAH (including Hereditary Hemorrhagic Telangiectasia), Associated (A)PAH (including collagen vascular disorders, drugs+toxins exposure, congenital heart disease, and portopulmonary disease).
  • Do not meet exclusion criteria

Exclusion Criteria:

  • Pulmonary Hypertension due to left heart disease (PH-LHD, WHO group 2), Pulmonary hypertension due to chronic lung disease (PH-CLD, WHO group 3), Chronic thrombo-embolic pulmonary hypertension (CTEPH, WHO group 4), pulmonary hypertension with unclear and/or multi-factorial mechanisms (WHO goup 5)
  • Inability to perform a 6 minute walk test (6MWT)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Initiating a new PAH medication
Participants will start a new PAH medication
Device: Home-based 6 minute walk test
Participants will receive a loaner Apple Watch with the Walk.Talk.Track. (WTT, produced by PHaware) app downloaded. Participants will perform a daily 6MWT at home using the Apple Watch and WTT app. They will undergo a history and physical, blood draw, echocardiogram and in-clinic 6MWT at the baseline and 12-week follow up visit.
Active Comparator: Continuing previous PAH medication regimen
Participants will continue the medication regimen that they were on prior to enrollment
Device: Home-based 6 minute walk test
Participants will receive a loaner Apple Watch with the Walk.Talk.Track. (WTT, produced by PHaware) app downloaded. Participants will perform a daily 6MWT at home using the Apple Watch and WTT app. They will undergo a history and physical, blood draw, echocardiogram and in-clinic 6MWT at the baseline and 12-week follow up visit.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
App/watch recorded and in-clinic recorded six minute walk distance (6MWD)
Time Frame: 12 weeks
App/watch recorded and in-clinic recorded 6MWD will be compared by Bland Altman graph and will be considered interchangeable if the line of equality lands within the 95% confidence interval of the mean difference
12 weeks
Count of participants with an increase of >32 meters in 6MWD from baseline as a measure of time to response to therapy
Time Frame: 12 weeks
Hazard ratios will be calculated at two week intervals to evaluate for between group differences
12 weeks
Count of participants with an increase of >3bpm in heart rate recovery at one minute (HRR1) from baseline as a measure of time to response to therapy
Time Frame: 12 weeks
HRR1 is calculated as peak heart rate (pHR) - HR one minute into recovery period. Hazard ratios will be calculated at two week intervals to evaluate for between group differences
12 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Count of participants with a decrease of >5bpm in resting HR from baseline as a measure of time to response to therapy
Time Frame: 12 weeks
Hazard ratios will be calculated at two week intervals to evaluate for between group differences
12 weeks
Count of participants with an increase of >5ms in heart rate variability (HRV) from baseline as a measure of time to response to therapy
Time Frame: 12 weeks
HRV will be calculated as the standard deviation of R wave to R wave intervals (SDNN) over the 2 minute period following exercise. Hazard ratios will be calculated at two week intervals to evaluate for between group differences
12 weeks
Count of participants with an increase of >5% in chronotropic index (CI) from baseline as a measure of time to response to therapy
Time Frame: 12 weeks
CI will be calculated as (actual peak HR - resting HR)/(Age predicted peak HR [220-age] - resting HR). Hazard ratios will be calculated at two week intervals to evaluate for between group differences
12 weeks
Within the treatment arm, count of participants with an increase of >3bpm in heart rate recovery at one minute (HRR1) from baseline when comparing medication responders vs non-responders
Time Frame: 12 weeks
Medication responders will have a ≥32m improvement in 6MWD at 12 weeks; non-responders will have <32m improvement. Hazard ratios will be calculated at two week intervals to evaluate for between group differences
12 weeks
Within the treatment arm, count of participants with a decrease of >5bpm in resting HR from baseline when comparing medication responders vs non-responders
Time Frame: 12 weeks
Medication responders will have a ≥32m improvement in 6MWD at 12 weeks; non-responders will have <32m improvement. Hazard ratios will be calculated at two week intervals to evaluate for between group differences
12 weeks
Within the treatment arm, count of participants with an increase of >5ms in heart rate variability (HRV) from baseline when comparing medication responders vs non-responders
Time Frame: 12 weeks
Medication responders will have a ≥32m improvement in 6MWD at 12 weeks; non-responders will have <32m improvement. Hazard ratios will be calculated at two week intervals to evaluate for between group differences
12 weeks
Within the treatment arm, count of participants with an increase of >5% in chronotropic index (CI) from baseline when comparing medication responders vs non-responders
Time Frame: 12 weeks
Medication responders will have a ≥32m improvement in 6MWD at 12 weeks; non-responders will have <32m improvement. Hazard ratios will be calculated at two week intervals to evaluate for between group differences
12 weeks
Between group difference in 6MWD as a measure of response to the intervention
Time Frame: 12 weeks
A two-sample T-test will be performed on the delta change in 6MWD (week 12 - baseline / baseline) x100]) between the treatment and control groups and a p-value will be calculated from this data.
12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Stanford University

Collaborators

PHaware

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2020

Primary Completion (Actual)

June 30, 2023

Study Completion (Actual)

June 30, 2023

Study Registration Dates

First Submitted

March 26, 2019

First Submitted That Met QC Criteria

March 26, 2019

First Posted (Actual)

March 28, 2019

Study Record Updates

Last Update Posted (Actual)

August 9, 2023

Last Update Submitted That Met QC Criteria

August 7, 2023

Last Verified

August 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SU-DynAMITE
  • IRB-48742 (Other Identifier: Administrative Panel on Human Subjects in Medical Research)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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