A MHealth System for Patients with POTS

NCT06296914 | Completed

• 1 other identifier: 89776
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (5)

• Change in POTSapp Usability as measured by uMARS

  The usability of the POTSapp will be the User Version of the Mobile Application Rating Scale (uMARS). The uMARS is a 26-item questionnaire that evaluates the quality of the mobile health applications with six subscales: engagement, functionality, aesthetics, information, app subjective quality, perceived impact. Scores on the scale can range from 21 to 130, where higher scores represent higher quality of mobile health applications by end-users.

  Month 4 and Month 8

• Change in POTSapp Usage - number of page views

  Usage will be measured by the number of page views as "clicks" on particular pages

  Month 4 and Month 8

• Change in POTSapp Usage - time spent in app

  Usage will be measured by the time spent on particular pages in the app.

  Month 4 and Month 8

• Change in POTSapp Usability as measured by Health-ITUES

  The Health Information Technology Usability Evaluation Scale (Health-ITUES) consists of 20 items rated on a five-point Likert scale from strongly disagree (1) to strongly agree (5). Scores range from 5-20. A higher scale value indicates higher perceived usability of the technology.

  Month 4 and Month 8

• Change in POTSapp Effectiveness as measured by Message Effectiveness scale

  Message Effectiveness scale consists of 9 items that examine message believability, memorability, likelihood that the message encourages participant to speak with healthcare provider, etc. This is a 5-point Likert type scale ranging from 1 = strongly disagree to 5 = strongly agree, where lower scores equal more disagreement and higher scores equal greater agreement.

  Month 4 and Month 8

Secondary Outcomes (4)

• Change in Participant Quality of Life

  Baseline and at 4 and 8 months

• Change in Doctor Patient Communication (DPC)

  Baseline and at 4 and 8 months

• Adapted IBS Perceived Stigma Scale

  4 and 8 months

• Cognitive Learning

  4 and 8 months

Study Arms (2)

POTSapp

EXPERIMENTAL

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.

Device: POTSapp

Waitlist Control

ACTIVE COMPARATOR

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.

Device: Waitlist Control

Interventions

POTSapp DEVICE

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

POTSapp

Waitlist Control DEVICE

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.

Waitlist Control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• patients who have not received a POTS diagnosis from a physician
• must have experienced at least two symptoms of POTS within the past three months (one symptom must include dizziness or pre-syncope upon standing)
• must have a clinic visit scheduled within 2-4 months post-recruitment

You may not qualify if:

• have been diagnosed with POTS already
• is not at least 18 years of age
• is not experiencing at least two symptoms of POTS within the past three months, including dizziness or pre-syncope upon standing.
• does not have a clinic visit scheduled within 4 months post-enrollment
• is taking a beta blocker.

Sponsors & Collaborators

• Jami Warren: lead

Study Sites (1)

University of Kentucky

Lexington, Kentucky, 40506, United States

Location

MeSH Terms

Conditions

Postural Orthostatic Tachycardia Syndrome

Condition Hierarchy (Ancestors)

Orthostatic Intolerance; Primary Dysautonomias; Autonomic Nervous System Diseases; Nervous System Diseases

Study Officials

• Jami Warren, PhD

  University of Kentucky

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: February 28, 2024
• First Posted: March 6, 2024
• Study Start: February 20, 2024
• Primary Completion: February 24, 2025
• Study Completion: February 24, 2025
• Last Updated: March 21, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)