nctId: NCT06296914 id: 89776 briefTitle: A mHealth System for Patients With POTS overallStatus: RECRUITING date: 2024-02-20 date: 2024-12-31 date: 2024-12-31 date: 2024-03-06 date: 2024-03-06 name: Jami Warren class: OTHER briefSummary: 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 studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: DIAGNOSTIC masking: NONE count: 20 type: ESTIMATED name: POTSapp name: Waitlist Control measure: Change in POTSapp Usability as measured by uMARS measure: Change in POTSapp Usage measure: Change in POTSapp Usability as measured by Health-ITUES measure: Change in POTSapp Effectiveness as measured by Message Effectiveness scale measure: Change in Participant Quality of Life measure: Change in Doctor Patient Communication (DPC) measure: Adapted IBS Perceived Stigma Scale measure: Cognitive Learning sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University of Kentucky status: RECRUITING city: Lexington state: Kentucky zip: 40506 country: United States name: Jami Warren, PhD role: CONTACT phone: 859-323-1100 email: jami.warren@uky.edu lat: 37.98869 lon: -84.47772 hasResults: False