Ignite Creation Date:
2024-05-06 @ 9:45 AM
Last Modification Date:
2024-10-26 @ 12:19 PM
Study NCT ID:
NCT03069716
Status:
COMPLETED
Last Update Posted:
2021-06-25
First Post:
2017-02-21
Brief Title:
A Mobile Health Intervention in Pulmonary Arterial Hypertension
Sponsor:
Vanderbilt University Medical Center
Organization:
Vanderbilt University Medical Center
Study Overview
Official Title:
A Mobile Health Intervention in Pulmonary Arterial Hypertension
Status:
COMPLETED
Status Verified Date:
2021-06
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:
mHealth
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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None