protocolSection identificationModule nctId: NCT06296914, orgStudyIdInfo id: 89776, briefTitle: A mHealth System for Patients With POTS, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-02-20, primaryCompletionDateStruct date: 2024-12-31, completionDateStruct date: 2024-12-31, studyFirstPostDateStruct date: 2024-03-06, lastUpdatePostDateStruct date: 2024-03-06, sponsorCollaboratorsModule leadSponsor name: Jami Warren, class: OTHER, descriptionModule 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., conditionsModule conditions: POTS - Postural Orthostatic Tachycardia Syndrome, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: DIAGNOSTIC, maskingInfo masking: NONE, enrollmentInfo count: 20, type: ESTIMATED, armsInterventionsModule interventions name: POTSapp, interventions name: Waitlist Control, outcomesModule primaryOutcomes measure: Change in POTSapp Usability as measured by uMARS, primaryOutcomes measure: Change in POTSapp Usage, primaryOutcomes measure: Change in POTSapp Usability as measured by Health-ITUES, primaryOutcomes measure: Change in POTSapp Effectiveness as measured by Message Effectiveness scale, secondaryOutcomes measure: Change in Participant Quality of Life, secondaryOutcomes measure: Change in Doctor Patient Communication (DPC), secondaryOutcomes measure: Adapted IBS Perceived Stigma Scale, secondaryOutcomes measure: Cognitive Learning, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: University of Kentucky, status: RECRUITING, city: Lexington, state: Kentucky, zip: 40506, country: United States, contacts name: Jami Warren, PhD, role: CONTACT, phone: 859-323-1100, email: jami.warren@uky.edu, geoPoint lat: 37.98869, lon: -84.47772, hasResults: False