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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline to one year after randomization.
Awards & highlights
MOVE PAH) Trial 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.Check my eligibility
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.See study design
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.
MOVE PAH) Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have PAH linked to a heart defect, drugs, or an unknown cause.
Select...
My lung function is good and I have little to no lung scarring.
MOVE PAH) Trial 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.
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
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 outcome measures
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 moreSide effects data
From 2016 Phase 3 trial • 300 Patients • NCT0200856551%
Constipation
9%
Urinary tract infection
6%
Diarrhoea
6%
Headache
5%
Fall
5%
Abdominal distension
5%
Abdominal pain
5%
Upper respiratory tract infection
3%
Nausea
2%
Haemorrhoids
1%
Breast cancer
1%
Hip fracture
1%
Syncope
1%
Medical device removal
1%
Back pain
1%
Animal bite
1%
Suture related complication
100%
80%
60%
40%
20%
0%
Study treatment Arm
Placebo - Education Only
Loperamide - Exercise Plus Biofeedback
Loperamide - Education Only
Placebo - Exercise Plus Biofeedback
MOVE PAH) 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
Find a Location
Who is running the clinical trial?
Vanderbilt University Medical CenterLead Sponsor
856 Previous Clinical Trials
672,057 Total Patients Enrolled
10 Trials studying Pulmonary Arterial Hypertension
2,395 Patients Enrolled for Pulmonary Arterial Hypertension
National Heart, Lung, and Blood Institute (NHLBI)NIH
3,836 Previous Clinical Trials
47,850,798 Total Patients Enrolled
25 Trials studying Pulmonary Arterial Hypertension
3,051 Patients Enrolled for Pulmonary Arterial Hypertension
Evan Brittain, MDPrincipal InvestigatorVanderbilt Medical Center
2 Previous Clinical Trials
184 Total Patients Enrolled
2 Trials studying Pulmonary Arterial Hypertension
184 Patients Enrolled for Pulmonary Arterial Hypertension
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My PAH is not caused by genetics, unknown reasons, or related conditions.I have PAH linked to a heart defect, drugs, or an unknown cause.My lung function is good and I have little to no lung scarring.You have a certain level of physical ability according to the World Health Organization's classification.My diuretic medication has been adjusted more than twice in the last three months.We can't track your preferred activities with an activity tracker, like swimming, yoga, or biking.I have severe heart failure that limits my daily activities.I am 18 years old or older.My PAH medication has been the same for the last 3 months, except for one diuretic change.I am unable to do normal activities because I use a wheelchair, walker, or have severe pain.
Research Study Groups:
This trial has the following groups:- Group 1: Usual Care
- Group 2: mHealth Intervention
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What is the primary objective of this medical experiment?
"This clinical trial evaluates Change in Quality of Life using the emPHasis-10 scale to assess its primary objective over a 24 week period. Secondary outcomes include Change in rated dyspnea as indicated by the Borg Dyspnea Score during six minute walk testing, Change in resting heart rate measured with an activity tracking device, and Time to Clinical Worsening which is composed of occurrences such as hospitalization or death due to pulmonary arterial hypertension."
Answered by AI
Are new participants being admitted to this trial at present?
"Affirmative. According to clinicaltrials.gov, this trial is currently seeking applicants for participation. The initial posting date was September 1st 2022 and the latest modification was on 9/22/2022. This research requires 100 volunteers from a single location."
Answered by AI
How many participants have signed up for the experiment?
"Affirmative. According to information held on clinicaltrials.gov, this experiment is currently recruiting subjects; it was first announced on September 1st 2022 and the listing was most recently updated on September 22nd 2022. The research requires 100 applicants across a single study site."
Answered by AI
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