The MObile Health InterVEntion in Pulmonary Arterial Hypertension (MOVE PAH) Study

Last updated: August 1, 2024
Sponsor: Vanderbilt University Medical Center
Overall Status: Active - Recruiting

Phase

N/A

Condition

Circulation Disorders

Stress

Williams Syndrome

Treatment

mHealth Intervention

Usual Care

Clinical Study ID

NCT05464095
220692
HL158941
  • Ages > 18
  • All Genders

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Adults aged 18 or older.

  • Diagnosed with idiopathic, heritable, or associated (connective tissue disease,drugs, or toxins) pulmonary arterial hypertension (PAH), or PAH due to simplecongenital heart disease (i.e. atrial septal defect).

  • WHO functional class I-III

  • Stable PAH-specific medication regimen for three months prior to enrollment.Subjects with only a single diuretic adjustment in the prior three months will beincluded. Adjustments in IV prostacyclin for side effect management are allowed.

  • Forced vital capacity >65% predicted with no or minimal interstitial lung diseasebased on reviews of imaging studies by PI and medical monitor.

Exclusion

Exclusion Criteria:

  • Prohibited from normal activity due to wheelchair bound status, bed bound status,reliance on a cane/walker, activity-limiting angina, activity-limitingosteoarthritis, or other condition that limits activity.

  • Pregnancy

  • Diagnosis of PAH etiology other than idiopathic, heritable, or associated.

  • Functional class IV heart failure

  • Requirement of > 2 diuretic adjustment in the prior three months.

  • Preferred form of activity is not measured by an activity tracker (swimming, yoga,ice skating, stair master, or activities on wheels such as bicycling orrollerblading).

Study Design

Total Participants: 100
Treatment Group(s): 2
Primary Treatment: mHealth Intervention
Phase:
Study Start date:
January 01, 2023
Estimated Completion Date:
August 31, 2027

Connect with a study center

  • Vanderbilt University Medical Center

    Nashville, Tennessee 37232
    United States

    Active - Recruiting

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