A MHealth System for Patients with POTS

Summary

Postural Orthostatic Tachycardia Syndrome (POTS) affects approximately 500,000 - 3 million Americans. This number will only increase due to the large number of patients experiencing POTS due to "long COVID." POTS patients experience several symptoms, including tachycardia, palpitations, dizziness, and pre-syncope or syncope, among others. POTS can be very debilitating and not only affect patients physically but also emotionally and financially. It takes an average of four years and seven doctors for POTS patients to achieve a diagnosis and it is often a frustrating and negative experience fraught with misdiagnoses, stigma, and depression and anxiety. Recent research demonstrates that mHealth technology may be one way that POTS patients can improve their experience in the healthcare system by providing objective data to their healthcare providers. Patients may also better take care of themselves through symptom monitoring and instant patient education via mHealth technology. The two study aims are: 1) Developing a mHealth app to improve the delay to diagnosis and the quality of life of POTS patients; and 2) Evaluate the usability and feasibility of the mHealth app and study design. To achieve these aims, researchers in this study will work with a programmer and leaders from the mHealth Application Modernization and Mobilization Alliance (MAMMA) and stakeholders (patients, caregivers, and providers) to co-design a mHealth app for POTS patients, including key educational components guided by the IDEA model, an instructional risk communication approach. A group of diagnosis-seeking POTS (n=20) patients will pilot test the app and provide feedback for improvement as well as evaluate its usability. Results from this study will allow researchers to acquire necessary data to apply for external funding to conduct a larger clinical trial to evaluate its influence on health outcomes, such as patient experience during visits with physicians, perceived stigma, and time to diagnosis.

Conditions

• POTS - Postural Orthostatic Tachycardia Syndrome

Interventions

DEVICE

POTSapp

Participants will be asked to document symptoms daily in the mHealth app and will be asked to conduct an "at home stand test" biweekly through the mHealth app. These participants will be asked to take an online survey at baseline, at 4 months, and at 8 months. T

DEVICE

Waitlist Control

Participants will receive educational information about online support for POTS via email. Starting at month 4, participants will receive equipment will be asked to document symptoms daily in the mHealth app and will be asked to conduct an "at home stand test" biweekly through the mHealth app. These participants will be asked to take an online survey at baseline, at 4 months, and at 8 months.

Sponsors & Collaborators

• Jami Warren

  lead OTHER

Principal Investigators

• Jami Warren, PhD · University of Kentucky

Study Design

Allocation

RANDOMIZED

Purpose

DIAGNOSTIC

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2024-02-20

Primary Completion

2025-02-24

Completion

2025-02-24

Countries

• United States

Study Locations