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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 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.

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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.

Interventions

  • DEVICE mHealth Intervention
  • DEVICE Usual Care

Study Locations (1)

Tennessee

  • Vanderbilt University Medical Center - Nashville

Trial Details

FieldValue
Enrollment Target 100 participants
Start Date 2023-01-01
Est. Completion 2027-08-31
Phase NA

What the Registry Record Tells You About NCT05464095

The ClinicalTrials.gov registry entry for NCT05464095 describes a study currently listed as recruiting, categorized as NA. The registered enrollment target is 100 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 461-participant average among 63 other Pulmonary Arterial Hypertension trials with a reported enrollment target (78% lower). The listed sponsor is Vanderbilt University Medical Center, which has 677 total studies on file at ClinicalTrials.gov.

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 1 study location spanning 1 distinct geographic area - top geographies include 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.

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