mHealth Intervention for Pulmonary Arterial Hypertension

(MOVE PAH) Trial)

Overseen By Evan Brittain, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Vanderbilt University Medical Center

Must be taking: PAH-specific medications

Disqualifiers: Wheelchair bound, Pregnancy, Heart failure, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 24 weeks

100 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new method to help people with pulmonary arterial hypertension (PAH), a condition affecting the lungs and heart, live better lives. Researchers compare usual care with a mobile health (mHealth) system that sends motivational text messages to encourage more physical activity. The goal is to determine if these texts can improve quality of life and exercise ability for people with PAH. This trial suits those with stable PAH who can perform activities like walking and are not limited by severe mobility issues. As an unphased trial, it offers a unique opportunity to contribute to innovative research that could enhance daily living for PAH patients.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but it requires that your PAH-specific medication regimen is stable for three months before joining. Minor adjustments in certain medications are allowed.

What prior data suggests that this mHealth intervention is safe for patients with pulmonary arterial hypertension?

Research has shown that mobile health (mHealth) tools, like the one being tested for pulmonary arterial hypertension (PAH), are generally safe. A small study on a similar digital platform, PAHcare™, found that patients managed it well, with no major safety issues.

mHealth tools often send text messages to help patients monitor their health and encourage increased activity. These tools are non-invasive, meaning they don't involve physical contact or medical procedures, which reduces the risk of side effects.

Overall, studies suggest that using mHealth tools for PAH is safe and can potentially enhance quality of life and exercise ability without causing harm. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the mHealth Intervention for Pulmonary Arterial Hypertension because it offers a fresh approach to managing the condition. Unlike traditional treatments like medications and oxygen therapy, this intervention uses a texting platform to enhance self-awareness and motivate patients to hit physical activity goals. By linking exercise with rewards or memorable cues, it encourages a more active lifestyle, which is crucial for managing symptoms. This innovative method aims to empower patients to take an active role in their health, potentially leading to better outcomes and improved quality of life.

What evidence suggests that this mHealth intervention is effective for pulmonary arterial hypertension?

Studies have shown that increased physical activity greatly benefits people with pulmonary arterial hypertension (PAH), enhancing their exercise capacity and overall quality of life. Research indicates that mobile health tools, such as text message reminders, can motivate PAH patients to become more active. One study found that automated text messages successfully increased physical activity in these patients. This trial will compare the mHealth Intervention, which uses a texting platform to promote self-awareness and reinforce step targets, with Usual Care. This support helps make exercise a regular habit, which is linked to better health outcomes for PAH. Increased activity can lead to improvements beyond what medications achieve. These early findings suggest that mobile health tools could play a crucial role in effectively managing PAH. ^{1 5 6 7 8}

Who Is on the Research Team?

Evan Brittain, MD

Principal Investigator

Vanderbilt Medical Center

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

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.

Exclusion Criteria

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

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

Pregnancy

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants are randomized to receive either the mHealth intervention or usual care for 6 months

24 weeks

Regular virtual check-ins

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessment of clinical worsening

1 year

What Are the Treatments Tested in This Trial?

Interventions

• mHealth Intervention
• Usual Care

Trial Overview 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.

How Is the Trial Designed?

Group I: Usual Care Experimental Treatment 1 Intervention

Routine medical care

Group II: mHealth Intervention Active Control 1 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.

Who Is Running the Clinical Trial?

Vanderbilt University Medical Center

Lead Sponsor

Trials

922

Recruited

939,000+

National Heart, Lung, and Blood Institute (NHLBI)

Collaborator

Trials

3,987

Recruited

47,860,000+

Published Research Related to This Trial

The smartphone app developed for measuring the 6-minute walk distance (6MWD) in patients with pulmonary arterial hypertension (PAH) showed strong correlation with conventional tests, indicating its validity for outdoor use, although it had some inaccuracies indoors.

Patients found the app usable and well-accepted, but compliance was low in 52% of participants, suggesting that motivation may depend on the app's integration into clinical decision-making.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

App-Based Versus Standard Six-Minute Walk Test in Pulmonary Hypertension: Mixed Methods Study. Salvi, D., Poffley, E., Tarassenko, L., et al.[2021]

A study of 40 patients with pulmonary arterial hypertension (PAH) and chronic thromboembolic pulmonary hypertension (CTEPH) found that the median daily step count was only 3913 steps, indicating low levels of physical activity in this population.

The most significant barriers to physical activity identified were lack of self-discipline, energy, and interest, with increases in perceived lack of interest and enjoyment correlating with substantial decreases in step counts, suggesting that interventions should focus on enhancing these areas.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Barriers to physical activity in patients with pulmonary hypertension. Cascino, TM., McLaughlin, VV., Richardson, CR., et al.[2020]

In a study of 108 patients with pulmonary arterial hypertension (PAH), the use of actigraphy to measure daily life physical activity (DLPA) showed that selexipag did not lead to significant improvements in physical activity levels compared to placebo over 24 weeks.

Despite high compliance with the accelerometer, changes in daily physical activity were small and variable, indicating that selexipag may not have a meaningful impact on improving quality of life through increased physical activity in this patient population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Assessing Daily Life Physical Activity by Actigraphy in Pulmonary Arterial Hypertension: Insights From the Randomized Controlled Study With Selexipag (TRACE). Howard, LS., Rosenkranz, S., Frantz, RP., et al.[2023]

mHealth interventions, particularly through text messaging and mobile applications, have shown effectiveness in managing hypertension, offering a cost-effective and engaging alternative to traditional methods.

There is a significant gap in research regarding the use of mHealth for hyperlipidemia management, and more studies are needed to assess long-term outcomes, cost-effectiveness, and the comparative efficacy of different mHealth strategies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mobile Health (mHealth) Technology for the Management of Hypertension and Hyperlipidemia: Slow Start but Loads of Potential. Rehman, H., Kamal, AK., Morris, PB., et al.[2022]

In a study involving 264 participants aged 35 to 74 with hypertension, e-counseling significantly reduced systolic blood pressure by an average of 10.1 mm Hg compared to 6.0 mm Hg in the control group after 12 months, indicating its efficacy in hypertension management.

E-counseling also led to improvements in pulse pressure and cardiovascular risk, demonstrating that combining technology with structured behavioral counseling can enhance the effectiveness of standard medical treatments for hypertension.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Randomized Controlled Trial of E-Counseling for Hypertension: REACH. Nolan, RP., Feldman, R., Dawes, M., et al.[2019]

The Hypertension Prevention Program (HPP) delivered through a mobile app with human coaching led to significant reductions in weight (-3.04 kg) and diastolic blood pressure (-5.06 mm Hg) among 50 adults over a 24-week period.

Participants who engaged with the program showed even greater improvements, with a reduction in systolic blood pressure of -7.75 mm Hg and weight loss of -3.73 kg, indicating that sustained engagement is crucial for maximizing the benefits of lifestyle interventions for hypertension.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of a mobile hypertension prevention delivery platform with human coaching. Toro-Ramos, T., Kim, Y., Wood, M., et al.[2018]

A systematic review of 51 studies found that eHealth interventions, particularly using more than two types, phone calls, and smartphone apps, significantly reduced both systolic and diastolic blood pressure, indicating their efficacy in managing hypertension.

Smartphone apps improved medication adherence by 45%, while other eHealth methods enhanced physical activity compliance and blood pressure control, suggesting that these digital tools can effectively support patients in managing their hypertension.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparative effect of eHealth interventions on hypertension management-related outcomes: A network meta-analysis. Cavero-Redondo, I., Saz-Lara, A., Sequí-Dominguez, I., et al.[2022]

A 12-week home-based physiotherapy program significantly improved exercise capacity in patients with pulmonary arterial hypertension (PAH), as evidenced by a notable increase in the 6-minute walk test (6MWT) distance by 51.8 meters after the program and 75.5 meters at a 6-month follow-up.

Participants in the physiotherapy group also showed significant increases in daily physical activity levels, particularly in low-intensity and moderate-intensity activities, while the control group did not experience any improvements.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Individually tailored home-based physiotherapy program makes sustainable improvement in exercise capacity and daily physical activity in patients with pulmonary arterial hypertension. Butāne, L., Spilva-Ekerte, L., Šablinskis, M., et al.[2022]

Patients and clinicians identified personalized physical activity, symptoms, and psychosocial well-being as crucial outcomes for evaluating treatment responses in pulmonary arterial hypertension (PAH).

Despite their importance, these outcomes are rarely measured in clinical trials for PAH, highlighting a gap in current research practices.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

"It's that invisible illness": Patient and clinician perspectives on outcomes in pulmonary arterial hypertension treatment. Auriemma, CL., Minhas, J., Blue, R., et al.[2023]

A 6-month mobile health (mHealth)-based disease management program significantly reduced both systolic and diastolic blood pressure in 125 participants with hypertension, diabetes, and dyslipidemia, indicating its efficacy for managing vascular disease risk.

The program was found to be safe, with no serious adverse events reported, suggesting it can be a reliable intervention for individuals with multiple lifestyle-related diseases.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Mobile Health-Based Disease Management Program Improves Blood Pressure in People With Multiple Lifestyle-Related Diseases at Risk of Developing Vascular Disease - A Retrospective Observational Study. Kanai, M., Toda, T., Yamamoto, K., et al.[2022]

Patients with pulmonary arterial hypertension who walked more than 400 meters in six minutes had a significantly lower risk of related death or hospitalization, indicating that this distance is a key marker for better long-term outcomes.

Changes in six-minute walk distance from baseline to Month 6 did not correlate with long-term risks, suggesting that the absolute distance walked is more critical for assessing patient prognosis than improvements over time.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Association between six-minute walk distance and long-term outcomes in patients with pulmonary arterial hypertension: Data from the randomized SERAPHIN trial. Souza, R., Channick, RN., Delcroix, M., et al.[2018]

A survey of pulmonary arterial hypertension (PAH) patients and healthy controls revealed that PAH patients have significantly lower daily activity levels compared to healthy individuals.

The study utilized smartphone and wearable fitness devices to track step counts, ensuring accurate measurement of activity levels while controlling for other influencing factors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Reduced free-living activity levels in pulmonary arterial hypertension patients. Halliday, SJ., Shi, H., Brittain, EL., et al.[2020]

In a meta-analysis of three randomized clinical trials involving 2508 patients with pulmonary arterial hypertension (PAH), the study found that commonly used multicomponent risk scores were not reliable surrogates for predicting long-term clinical outcomes like mortality or clinical worsening.

The analysis revealed that the treatment effects on achieving low-risk status at 16 weeks explained only a small portion (7% to 13%) of the treatment effects on long-term outcomes, indicating that these risk scores may lead to biased conclusions in PAH research.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Is low-risk status a surrogate outcome in pulmonary arterial hypertension? An analysis of three randomised trials. Blette, BS., Moutchia, J., Al-Naamani, N., et al.[2023]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT03069716

A Mobile Health Intervention in Pulmonary Arterial ... This study proposes the use of a mobile health intervention (utilizing a smart phone app) to encourage increased exercise in PAH patients.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8449004/

A Mobile Health Intervention to Increase Physical Activity in ... Supervised exercise training improves outcomes in patients with pulmonary arterial hypertension (PAH). The effect of an unsupervised activity intervention ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT05464095

The MObile Health InterVEntion in Pulmonary Arterial ... Patients with pulmonary arterial hypertension (PAH) have reduced health related quality of life (HRQOL) and impaired exercise capacity.

4. reporter.nih.gov reporter.nih.gov/search/EaC3BhVN6USBfOMuTswDVQ/project-details/10930697

Project Details - NIH RePORTER This proposal will test a novel, highly scalable, and affordable mHealth intervention to improve clinically meaningful outcomes in patients with PAH. Public ...

5. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0012369221006991

A Mobile Health Intervention to Increase Physical Activity in ... This study demonstrated the feasibility of an automated text message-based intervention to increase physical activity in patients with PAH.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10904626/

Assessing the clinical benefit, safety, and patient-reported ... We conducted a pilot study to evaluate the clinical benefit and safe use of the PAHcare™ digital platform as a novel, patient-centred mHealth ...

7. sciencedirect.com sciencedirect.com/science/article/pii/S2666668525000588

The role of artificial intelligence and mobile health in ... Pulmonary arterial hypertension (PAH) is a rare, progressive disorder characterized by pulmonary vascular remodeling, increased pulmonary ...

8. trialfinder.panfoundation.org trialfinder.panfoundation.org/en-US/trial/listing/511104

The MObile Health InterVEntion in Pulmonary Arterial ... Despite fourteen approved therapies, most patients die within ten years. Increasing physical activity is highly efficacious in PAH, resulting in six-minute walk ...