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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Time periods mentioned: 6 months
  • Procedures mentioned: Questionnaires

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "The Investigators propose a randomized trial of smart texts versus usual care for 6 months."
  • "The Investigators will test the effect of a text-based mHealth intervention on HRQOL in PAH using the PAH-specific emPHasis-10 questionnaire."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests whether smart text messages can improve quality of life and walking ability in adults with pulmonary arterial hypertension (PAH), or high blood pressure in the lungs. It compares text messages with usual care for 6 months and checks for worsening health after 1 year.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • You are age 18 or older.
  • You have PAH with no known cause, passed down in families, or linked to connective tissue disease, drugs, or toxins. PAH caused by a simple heart defect present at birth, such as a hole between the heart’s upper chambers, also qualifies.
  • Your PAH is in WHO class I–III, meaning it causes no, mild, or marked limits on physical activity.
  • Your PAH medicines have been stable for 3 months. One change to a water pill is allowed, as are changes to IV prostacyclin medicine to manage side effects.
  • A breathing test shows you can blow out more than 65% of the expected amount of air. Study doctors must find no or very little lung tissue disease on your scans.

Who can't join

  • You cannot do normal activities because you use a wheelchair, stay in bed, rely on a cane or walker, or have limiting chest pain, joint arthritis, or another condition.
  • You are pregnant.
  • Your PAH has a cause other than the types allowed in the study.
  • You have class IV heart failure, meaning symptoms occur even at rest.
  • You needed more than 2 changes to water pills in the past 3 months.
  • Your preferred activity cannot be measured by an activity tracker, such as swimming, yoga, ice skating, using a stair machine, biking, or rollerblading.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

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 simple congenital 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 be included. Adjustments in IV prostacyclin for side effect management are allowed. * Forced vital capacity \>65% predicted with no or minimal interstitial lung disease based on reviews of imaging studies by PI and medical monitor. Exclusion Criteria: * Prohibited from normal activity due to wheelchair bound status, bed bound status, reliance on a cane/walker, activity-limiting angina, activity-limiting osteoarthritis, 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 or rollerblading).

Study sites (1)

TN