Mobile Health App for POTS

Overseen By Jami Warren, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Jami Warren

Must not be taking: Beta blockers

Disqualifiers: POTS diagnosis, Under 18, others

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

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a mobile health app called POTSapp, designed to assist individuals who suspect they have Postural Orthostatic Tachycardia Syndrome (POTS), a condition causing symptoms like a rapid heartbeat and dizziness when standing. The app aims to simplify symptom tracking and data sharing with doctors, potentially speeding up diagnosis and enhancing the healthcare experience. Participants will receive devices such as a smartwatch and a Bluetooth blood pressure monitor to use with the app. Ideal participants have experienced at least two POTS symptoms in the past three months, including dizziness when standing, and have a clinic visit planned within the next 2-4 months. As an unphased trial, this study offers participants the chance to contribute to innovative healthcare solutions and potentially improve their own symptom management.

Will I have to stop taking my current medications?

If you are taking a beta blocker, you cannot participate in this trial. The protocol does not specify about other medications, so it's best to discuss with the trial team.

What prior data suggests that this mobile health app is safe for POTS patients?

Research has shown that mobile health apps, such as the POTSapp under study, are generally safe and easy to use. These apps provide patients with important health information and support. Since they do not involve medication or medical procedures, they pose no risk of physical side effects.

In other studies, users of health apps reported finding them helpful and easy to use, and they felt more informed about their health. The POTSapp incorporates a smartwatch and a blood pressure monitor, which are unlikely to cause harm. Users of similar technology in the past have not reported any serious problems.

Overall, using a health app like POTSapp is considered a safe way to manage conditions such as Postural Orthostatic Tachycardia Syndrome (POTS). ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the POTSapp because it offers a tech-driven approach to managing Postural Orthostatic Tachycardia Syndrome (POTS), leveraging a mobile health app and smart devices like a smartwatch and Bluetooth blood pressure monitor. Unlike traditional treatments that rely heavily on medication and lifestyle changes, this app focuses on real-time monitoring and self-management, empowering patients to better understand and control their symptoms. The use of technology to gather continuous data can potentially lead to more personalized and timely interventions, which is a significant advancement over current standard care practices.

What evidence suggests that this mobile health app is effective for POTS?

Research has shown that mobile health (mHealth) technology can help individuals with Postural Orthostatic Tachycardia Syndrome (POTS) manage their symptoms more effectively. People with POTS often experience a rapid heart rate upon standing, complicating everyday tasks. Studies suggest that non-drug methods, such as tracking symptoms and learning through apps, can be as beneficial as medication. In this trial, participants in the POTSapp arm will use the POTSapp, designed to enhance patient experiences by providing tools to monitor symptoms and access information quickly. Early results indicate that this approach could help individuals better understand and manage their POTS symptoms, potentially improving their quality of life and speeding up the diagnosis process. ^{2 6 7 8 9}

Who Is on the Research Team?

Jami Warren, PhD

Principal Investigator

University of Kentucky

Are You a Good Fit for This Trial?

This trial is for individuals with Postural Orthostatic Tachycardia Syndrome (POTS), including those who may have developed POTS after 'long COVID'. Participants should be seeking a diagnosis and willing to use mHealth technology for symptom monitoring and education.

Inclusion Criteria

Patients who have not received a POTS diagnosis from a physician

I have a clinic visit scheduled within 2-4 months after joining.

I have had dizziness or near-fainting when standing up, along with another POTS symptom in the last 3 months.

Exclusion Criteria

I haven't had symptoms like dizziness when standing up in the last 3 months.

I am under 18 years old.

I am currently taking a beta blocker medication.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

App Development and Testing

Development of a mHealth app using a user-centered co-design and iterative rapid cycle testing approach

Not specified

Pilot Testing

A two-arm, 8-month pilot randomized controlled trial to evaluate the usability and feasibility of the mHealth app

8 months

Virtual Zoom meetings for app installation and usage training

Follow-up

Participants are monitored for changes in app usage, cognitive learning, quality of life, and doctor-patient communication

4 months

What Are the Treatments Tested in This Trial?

Interventions

• POTSapp

Trial Overview The study is testing a mobile health app (mHealth) designed to help POTS patients manage their condition. It aims to reduce the time it takes to get diagnosed, improve quality of life, and provide instant patient education.

How Is the Trial Designed?

Group I: POTSapp Experimental Treatment 1 Intervention

Participants will receive a smart watch and Bluetooth blood pressure monitor and attend a virtual Zoom meeting to learn how to install and use the app with devices.

Group II: Waitlist Control Active Control 1 Intervention

Participants will receive an emailed information sheet containing online support information on POTS. After the initial 4- month period is over, participants will receive a smart watch and Bluetooth blood pressure monitor and attend a virtual Zoom meeting to learn how to install and use the app with devices.

Who Is Running the Clinical Trial?

Jami Warren

Lead Sponsor

Trials

1

Recruited

20+

Citations

1. ahajournals.org ahajournals.org/doi/10.1161/JAHA.125.042365

Long‐Term Postural Orthostatic Tachycardia Syndrome ... Only 26% of patients were able to work >40 hours/week, with 35% having reduced hours due to POTS symptoms. Significant loss of income and ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11292765/

Long‐Term POTS Outcomes Survey: Diagnosis, Therapy ... The LT‐POTS (Long Term POTS Outcomes Survey) included questions about quality of life, symptoms, therapies, education, employment, and social impact of disease.

3. jacc.org jacc.org/doi/10.1016/j.jacadv.2025.101873

Characterization of Postural Orthostatic Tachycardia ... Patients with POTS experience increased heart rate when standing, which often results in a decreased ability to participate in education and ...

4. mayo.edu mayo.edu/research/clinical-trials/diseases-conditions/postural-orthostatic-tachycardia-syndrome

Postural Orthostatic Tachycardia Syndrome Clinical Trials The aims of this study will be to measure changes in postural orthostatic tachycardia syndrome (POTS) symptoms, functional disability and catastrophizing.

5. ncbi.nlm.nih.gov ncbi.nlm.nih.gov/books/NBK541074/

Postural Orthostatic Tachycardia Syndrome - NCBI - NIH [11] POTS medications are not proven to be more effective than non-pharmacologic approaches and should be utilized with caution, given potential adverse ...

6. my.clevelandclinic.org my.clevelandclinic.org/health/diseases/16560-postural-orthostatic-tachycardia-syndrome-pots

Postural orthostatic tachycardia syndrome (POTS) POTS is a condition that causes a number of symptoms when you transition from lying down to standing up, such as a fast heart rate, dizziness and fatigue.

7. hopkinsmedicine.org hopkinsmedicine.org/health/conditions-and-diseases/postural-orthostatic-tachycardia-syndrome-pots

Postural Orthostatic Tachycardia Syndrome (POTS) POTS is diagnosed only when orthostatic hypotension is ruled out and when there is no acute dehydration or blood loss.

8. dysautonomiainternational.org dysautonomiainternational.org/page.php?ID=30

Postural Orthostatic Tachycardia Syndrome The current diagnostic criteria for POTS is a heart rate increase of 30 beats per minute (bpm) or more, or over 120 bpm, within the first 10 minutes of standing ...

9. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC1501099/

The Postural Tachycardia Syndrome (POTS): Pathophysiology ... POTS is a disorder of the autonomic nervous system in which many symptoms can be treated. The cardinal manifestation is symptomatic orthostatic tachycardia.