Mobile Health App for POTS
Trial Summary
What is the purpose of this trial?
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.
Research Team
Jami Warren, PhD
Principal Investigator
University of Kentucky
Eligibility Criteria
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
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
App Development and Testing
Development of a mHealth app using a user-centered co-design and iterative rapid cycle testing approach
Pilot Testing
A two-arm, 8-month pilot randomized controlled trial to evaluate the usability and feasibility of the mHealth app
Follow-up
Participants are monitored for changes in app usage, cognitive learning, quality of life, and doctor-patient communication
Treatment Details
Interventions
- POTSapp
Find a Clinic Near You
Who Is Running the Clinical Trial?
Jami Warren
Lead Sponsor