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NCT05464095 · ClinicalTrials.gov registry record · NA
The MObile Health InterVEntion in Pulmonary Arterial Hypertension (MOVE PAH) Study
A NA study of Pulmonary Arterial Hypertension, sponsored by Vanderbilt University Medical Center.
- Recruiting
- Registry status
- NA
- Development phase
- 100
- Enrollment target
- 1
- Study location
NCT05464095: Recruiting NA study of Pulmonary Arterial Hypertension, sponsored by Vanderbilt University Medical Center.
NCT05464095 is a NA study of Pulmonary Arterial Hypertension that is actively recruiting participants, run by Vanderbilt University Medical Center. The registered enrollment target is 100 participants, below the 461-participant average among 63 other Pulmonary Arterial Hypertension trials with a reported enrollment target (78% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05464095, a NA study of Pulmonary Arterial Hypertension, is actively recruiting participants, sponsored by Vanderbilt University Medical Center.
- RECRUITING
- Registry status
- NA
- Development phase
- 100 participants
- Enrollment target
- 1
- Study location
Study Summary
Patients with pulmonary arterial hypertension (PAH) have reduced health related quality of life (HRQOL) and impaired exercise capacity. Despite fourteen approved therapies, most patients die within ten years. Increasing physical activity is highly efficacious in PAH, resulting in six-minute walk distance (6MWD) and HRQOL improvement that often exceeds the effect of medications. Prior activity studies required inpatient rehabilitation, which is impractical, hard to sustain, and poorly scalable to a rare disease. The Investigators propose a randomized trial of smart texts versus usual care for 6 months. The Investigators will randomize 100 PAH patients to the mHealth intervention or usual care. The Investigators will test the effect of a text-based mHealth intervention on HRQOL in PAH using the PAH-specific emPHasis-10 questionnaire. The Investigators will also test the effect of an mHealth intervention on exercise capacity, measured by a supervised home-based 6MWD test. Finally, the Investigators will examine the effect of the intervention on time to clinical worsening (composite of PAH therapy escalation, PAH hospitalization, and death) one year after randomization.
Primary Outcome
The SF-36 is a 36 item scale, which measures eight domains of health status: physical functioning (10 items); physical role limitations (four items); bodily pain (two items); general health perceptions (five items); energy/vitality (four items); social functioning (two items); emotional role limitations (three items) and mental health (five items). A scoring algorithm is used to convert the raw scores into the eight dimensions listed above. The scores are transformed to range from zero where the
Conditions Studied
Interventions
- DEVICE mHealth Intervention
- DEVICE Usual Care
Study Locations (1)
Tennessee
- Vanderbilt University Medical Center - Nashville
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 100 participants |
| Start Date | 2023-01-01 |
| Est. Completion | 2027-08-31 |
| Phase | NA |
What NCT05464095 shows while recruiting
NCT05464095 is an interventional study that assigns participants to a tested intervention. The registered 100 participants enrollment target is mid-sized for trials with a published cap, below the 461-participant average among 63 other Pulmonary Arterial Hypertension trials with a reported enrollment target (78% lower).
The record links to 1 condition, with Pulmonary Arterial Hypertension appearing as the primary indexed condition, and to 2 interventions - of which mHealth Intervention is the first listed.
NCT05464095 reports a single indexed study location in Tennessee.
Frequently Asked Questions
What is clinical trial NCT05464095 about?
NCT05464095 is a clinical study titled "The MObile Health InterVEntion in Pulmonary Arterial Hypertension (MOVE PAH) Study". Patients with pulmonary arterial hypertension (PAH) have reduced health related quality of life (HRQOL) and impaired exercise capacity. Despite fourteen approved therapies, most patients die within ten years. Increasing physical activity is highly efficacious in PAH, resulting in six-minute walk dis...
What is the current status of trial NCT05464095?
This trial is currently recruiting. It is a NA study. The enrollment target is 100 participants. The study started on 2023-01-01. Estimated completion is 2027-08-31.
What conditions does trial NCT05464095 study?
This clinical trial studies the following conditions: Pulmonary Arterial Hypertension.
What interventions are being tested in trial NCT05464095?
The interventions under investigation include: mHealth Intervention (DEVICE), Usual Care (DEVICE).
Who is sponsoring clinical trial NCT05464095?
This trial is sponsored by Vanderbilt University Medical Center, which has 677 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05464095 being conducted?
This trial has 1 study location across Tennessee. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT05464095's enrollment target sits among peer trials
100 19th of 63 higher than 45 of 63 other Pulmonary Arterial Hypertension trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Pulmonary Arterial Hypertension trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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