Ignite Creation Date:
2024-05-06 @ 12:57 PM
Last Modification Date:
2024-10-26 @ 1:06 PM
Study NCT ID:
NCT03893500
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-05-03
First Post:
2019-03-26
Brief Title:
Utility of At-home Monitoring of Exercise Capacity by App-based 6-minute Walk Test
Sponsor:
Stanford University
Organization:
Stanford University
Study Overview
Official Title:
Utility of Device and App-based Mobile Health Monitoring as a Tool for Evaluation of Clinical Response to Therapies in Pulmonary Arterial Hypertension
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
DynAMITE
Brief Summary:
Evaluate for accuracy and reproducibility of data collected via the participant-operated WalkTalkTrack WTT app combined with Apple Watch during in-clinic technician proctored 6MWTs
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 andor CI are more evident in treatment responders when compared to treatment non-responders
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 andor CI are more evident in treatment responders when compared to treatment non-responders
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
True
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| IRB-48742 | OTHER | Administrative Panel on Human Subjects in Medical Research | None |