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NCT06296914 · ClinicalTrials.gov registry record · NA

A MHealth System for Patients with POTS

A NA study of POTS - Postural Orthostatic Tachycardia Syndrome, sponsored by Jami Warren.

Completed
Registry status
NA
Development phase
20
Enrollment target
1
Study location

NCT06296914 is a NA study of POTS - Postural Orthostatic Tachycardia Syndrome that has completed, run by Jami Warren. The registered enrollment target is 20 participants, below the 84-participant average among 5 other POTS - Postural Orthostatic Tachycardia Syndrome trials with a reported enrollment target (76% lower). The trial reports 1 study location across 1 state.

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The verdict

NCT06296914, a NA study of POTS - Postural Orthostatic Tachycardia Syndrome, has completed, sponsored by Jami Warren.

COMPLETED
Registry status
NA
Development phase
20 participants
Enrollment target
1
Study location

Study 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 diagno

Interventions

  • DEVICE POTSapp
  • DEVICE Waitlist Control

Study Locations (1)

Kentucky

  • University of Kentucky - Lexington

Trial Details

FieldValue
Enrollment Target 20 participants
Start Date 2024-02-20
Est. Completion 2025-02-24
Phase NA

Sponsor

Jami Warren

1 total trials

What the Registry Record Tells You About NCT06296914

The ClinicalTrials.gov registry entry for NCT06296914 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 20 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 84-participant average among 5 other POTS - Postural Orthostatic Tachycardia Syndrome trials with a reported enrollment target (76% lower). The listed sponsor is Jami Warren, which has 1 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with POTS - Postural Orthostatic Tachycardia Syndrome appearing as the primary indexed condition, and to 2 interventions - of which POTSapp is the first listed.

NCT06296914 reports 1 study location spanning 1 distinct geographic area - top geographies include Kentucky.

Frequently Asked Questions

What is clinical trial NCT06296914 about?

NCT06296914 is a clinical study titled "A MHealth System for Patients with POTS". 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, a...

What is the current status of trial NCT06296914?

This trial is currently completed. It is a NA study. The enrollment target is 20 participants. The study started on 2024-02-20. Estimated completion is 2025-02-24.

What conditions does trial NCT06296914 study?

This clinical trial studies the following conditions: POTS - Postural Orthostatic Tachycardia Syndrome.

What interventions are being tested in trial NCT06296914?

The interventions under investigation include: POTSapp (DEVICE), Waitlist Control (DEVICE).

Who is sponsoring clinical trial NCT06296914?

This trial is sponsored by Jami Warren, which has 1 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT06296914 being conducted?

This trial has 1 study location across Kentucky. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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