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

NCT05464095 | Recruiting

• 2 other identifiers: 220692HL158941
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Pulmonary Arterial Hypertension

Outcome Measures

Primary Outcomes (2)

• Change in Quality of Life as measured by the Short Form Survey (SF-36)

  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 respondent has the worst possible health to 100 where the respondent is in the best possible health.

  Baseline to 24 weeks

• Change in Quality of Life as measured by the emPHasis-10

  The emPHasis-10 is a short and easy questionnaire that consists of 10 items that address breathlessness, fatigue, control, and confidence. Each item is scored on a semantic differential six-point scale (0-5), with contrasting adjectives at each end. A total emPHasis-10 score is derived using simple aggregation of the 10 items. emPHasis-10 scores range from 0 to 50, higher scores indicate worse quality of life.

  Baseline to 24 weeks

Secondary Outcomes (4)

• Change in meters walked from baseline to 24 weeks in six minute walk distance (meters)

  baseline and 24 weeks

• Change in rated dyspnea from baseline to 24 weeks using the Borg Dyspnea Score

  baseline and 24 weeks

• Change in resting heart rate from baseline to 24 weeks (beats per minute)

  baseline and 24 weeks

• Time to clinical worsening

  baseline to one year after randomization.

Study Arms (2)

mHealth Intervention

ACTIVE COMPARATOR

Patients will be randomized to the mHealth texting platform, which are messages designed to facilitate self-awareness, reinforce step targets, and link physical activity with a reward or memorable cue.

Device: mHealth Intervention

Usual Care

OTHER

Routine medical care

Device: Usual Care

Interventions

mHealth Intervention DEVICE

The Health Insurance Portability and Accountability Act (HIPPA) compliant texting platform is linked to the Fitbit Application Program Interface. Real time activity data will be transmitted from the subject's smartphone to the mHealth platform via cellular network. Participants assigned to the texting arm will receive 3 texts/day in sync with their preferred morning, lunch, and evening leisure schedule, which is defined at enrollment. These texts will use personal, disease-specific, and provider information to deliver 2 types of messages customized to the current step count and sent in equal proportion. Messages are designed to facilitate self-awareness, reinforce step targets, and link physical activity with a reward or memorable cue.

mHealth Intervention

Usual Care DEVICE

The HIPPA-compliant texting platform is linked to the Fitbit Application Program Interface. Real-time activity data will be transmitted from the subject's smartphone to the mHealth platform via cellular network.

Usual Care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Vanderbilt University Medical Center: lead
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

Study Sites (1)

Vanderbilt University Medical Center

Nashville, Tennessee, 37232, United States

RECRUITING

MeSH Terms

Conditions

Pulmonary Arterial Hypertension

Condition Hierarchy (Ancestors)

Hypertension, Pulmonary; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Evan Brittain, MD

  Vanderbilt Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Alisha Lindsey, RT

CONTACT

615-322-3412; alisha.lindsey@vumc.org

Evan Brittain, MD

CONTACT

615-322-2318; evan.brittain@vumc.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The investigators and study coordinators will be blinded to treatment arms
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Model Details: Randomized, single-blinded, parallel group, Phase II study of 100 subjects with PAH. Eligible subjects will be randomly assigned to receive the mHealth intervention or not for twenty-four weeks.

Study Record Dates

• First Submitted: July 15, 2022
• First Posted: July 19, 2022
• Study Start: January 1, 2023
• Primary Completion (Estimated): May 3, 2027
• Study Completion (Estimated): August 31, 2027
• Last Updated: August 14, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)