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Behavioural Intervention

mHealth Intervention for Pulmonary Arterial Hypertension (MOVE PAH) Trial)

N/A

Recruiting

Led By Evan Brittain, MD

Research Sponsored by Vanderbilt University Medical Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

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)

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

Must not have

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

Requirement of > 2 diuretic adjustment in the prior three months

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline to one year after randomization.

Awards & highlights

No Placebo-Only Group

Summary

This trial will test whether a text-based mHealth intervention can improve HRQOL and exercise capacity in PAH patients.

Who is the study for?

Adults over 18 with pulmonary arterial hypertension (PAH) who can walk and have stable PAH medication for the last three months. They should not be in heart failure class IV, pregnant, or primarily engaged in activities that aren't tracked by an activity tracker like swimming or bicycling.

What is being tested?

The study is testing a mobile health intervention using smart texts to improve quality of life and exercise capacity against usual care in PAH patients. It's a randomized trial where participants' health outcomes will be monitored over six months.

What are the potential side effects?

Since this trial involves a non-invasive mHealth intervention rather than medication, traditional side effects are not expected. However, increased physical activity could potentially cause fatigue or discomfort.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have PAH linked to a heart defect, drugs, or an unknown cause.

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My lung function is good and I have little to no lung scarring.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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My PAH is not caused by genetics, unknown reasons, or related conditions.

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My diuretic medication has been adjusted more than twice in the last three months.

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I have severe heart failure that limits my daily activities.

Select...

I am unable to do normal activities because I use a wheelchair, walker, or have severe pain.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline to one year after randomization.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline to one year after randomization.

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to one year after randomization. for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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

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

Secondary study objectives

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

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

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

+1 more

Side effects data

From 2016 Phase 3 trial • 300 Patients • NCT02008565

51%

Constipation

Urinary tract infection

Diarrhoea

Headache

Fall

Abdominal distension

Abdominal pain

Upper respiratory tract infection

Nausea

Haemorrhoids

Hip fracture

Breast cancer

Syncope

Medical device removal

Back pain

Animal bite

Suture related complication

100%

80%

60%

40%

20%

Study treatment Arm

Placebo - Education Only

Loperamide - Exercise Plus Biofeedback

Loperamide - Education Only

Placebo - Exercise Plus Biofeedback

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Usual CareExperimental Treatment1 Intervention

Routine medical care

Group II: mHealth InterventionActive Control1 Intervention

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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Usual Care

1990

Completed Phase 4

~7700

0 / 6Eligibility criteria met