mHealth Intervention for Pulmonary Arterial Hypertension

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Pulmonary Arterial Hypertension+6 MoremHealth Intervention - Device
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This trial will test whether a text-based mHealth intervention can improve HRQOL and exercise capacity in PAH patients.

Eligible Conditions
  • Pulmonary Arterial Hypertension

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

2 Primary · 4 Secondary · Reporting Duration: baseline to one year after randomization.

Baseline to 24 weeks
Change in Quality of Life as measured by the Short Form Survey (SF-36)
Change in Quality of Life as measured by the emPHasis-10
baseline and 24 weeks
Change in meters walked from baseline to 24 weeks in six minute walk distance (meters)
Change in rated dyspnea from baseline to 24 weeks using the Borg Dyspnea Score
Change in resting heart rate from baseline to 24 weeks (beats per minute)
baseline to one year after randomization.
Time to clinical worsening

Trial Safety

Trial Design

1 Treatment Group

mHealth Intervention
1 of 1

Active Control

100 Total Participants · 1 Treatment Group

Primary Treatment: mHealth Intervention · No Placebo Group · N/A

mHealth Intervention
Device
ActiveComparator Group · 1 Intervention: mHealth Intervention · Intervention Types: Device

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: baseline to one year after randomization.

Who is running the clinical trial?

Vanderbilt University Medical CenterLead Sponsor
771 Previous Clinical Trials
590,452 Total Patients Enrolled
9 Trials studying Pulmonary Arterial Hypertension
2,413 Patients Enrolled for Pulmonary Arterial Hypertension
National Heart, Lung, and Blood Institute (NHLBI)NIH
3,588 Previous Clinical Trials
46,945,602 Total Patients Enrolled
20 Trials studying Pulmonary Arterial Hypertension
2,184 Patients Enrolled for Pulmonary Arterial Hypertension
Evan Brittain, MDPrincipal InvestigatorVanderbilt Medical Center
2 Previous Clinical Trials
184 Total Patients Enrolled
2 Trials studying Pulmonary Arterial Hypertension
184 Patients Enrolled for Pulmonary Arterial Hypertension

Eligibility Criteria

Age 18+ · All Participants · 5 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You have idiopathic, heritable, or associated (connective tissue disease, drugs, or toxins) pulmonary arterial hypertension (PAH), or PAH due to simple congenital heart disease (i.e.