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Behavioural Intervention

POTSapp for Postural Orthostatic Tachycardia Syndrome

N/A

Recruiting

Led By Jami Warren, PhD

Research Sponsored by Jami Warren

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 4 and 8 months

Awards & highlights

Study Summary

This trial aims to develop and test a mobile health app for patients with Postural Orthostatic Tachycardia Syndrome (POTS) to improve their quality of life and reduce the time it

Who is the study for?

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.Check my eligibility

What is being tested?

The study is testing a mobile health app (mHealth) designed to help POTS patients manage their condition. It aims to reduce the time it takes to get diagnosed, improve quality of life, and provide instant patient education.See study design

What are the potential side effects?

Since this trial involves using an app rather than medication, traditional side effects are not expected. However, participants might experience frustration or stress if they encounter technical issues or find the app unhelpful.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 4 and 8 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~4 and 8 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 4 and 8 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Change in POTSapp Effectiveness as measured by Message Effectiveness scale

Change in POTSapp Usability as measured by Health-ITUES

Change in POTSapp Usability as measured by uMARS

+1 more

Secondary outcome measures

Adapted IBS Perceived Stigma Scale

Change in Doctor Patient Communication (DPC)

Change in Participant Quality of Life

+1 more

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: POTSappExperimental Treatment1 Intervention

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.

Group II: Waitlist ControlActive Control1 Intervention

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.

Do I qualify?Apply below to find out

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Who is running the clinical trial?

Jami WarrenLead Sponsor

Jami Warren, PhDPrincipal InvestigatorUniversity of Kentucky

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any current opportunities for individuals to participate in this ongoing medical study?

"As per clinicaltrials.gov, this research study is presently seeking eligible participants. The trial was first listed on 20th February 2024 and had its most recent update on 28th February 2024."

Answered by AI

What is the current number of individuals being admitted into this research investigation?

"Affirmative, as per clinicaltrials.gov data, this medical investigation is currently enrolling participants. The trial was first listed on February 20th, 2024 and the latest update was made on February 28th, 2024. Enrollment aims to include 20 subjects from a single research site."

Answered by AI

What are the projected results that researchers hope to achieve with this investigation?

"The primary goal of this clinical investigation, to be evaluated around Month 4 and Month 8, is the alteration in POTSapp Efficiency gauged by Message Effectiveness assessment. Supplementary aims consist of shifts in Doctor-Patient Communication (DPC) appraised through a questionnaire encompassing 15 items with graded responses ranging from Likert scale values of 1 to 4 – indicating that higher scores denote enhanced communication proficiency while lower scores signify diminished proficiency. Cognitive Learning will also be measured using a ten-item scale assessing comprehension levels of educational content delivered via the mobile application; ratings span from 0-4 where increased values indicate more profound"

Answered by AI