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Kardia Mobile 6L Device for Atrial Fibrillation

Q: What is the criteria to be admitted into this medical experiment?

<p>A total of 100 individuals with <a href="https://www.withpower.com/clinical-trials/atrial-fibrillation">atrial fibrillation</a>, aged 18 to 90 years old, are being enrolled in this study. To be eligible for enrollment they must satisfy the following criteria: between 18-90 years of age; diagnosed within 6 months; possessing a functioning smartphone and data plan; able to physically and mentally record reliable ECG readings on KardiaMobile device; have an estimated life expectancy over 12 months.</p>

N/A

Waitlist Available

Research Sponsored by Northwestern University

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 6 months

Awards & highlights

Study Summary

This trial is comparing a new way to record ECGs (KardiaMobile) to the standard of care. The new way uses a smart phone and the patient can do it themselves when they have symptoms. The trial will last 6 months and will compare how often people in each group use their device and how often they have to go to the doctor or hospital.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 6 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~6 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 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

To compare healthcare utilization through a questionnaire asking how many office appointments, emergency department visits, and hospital admissions they had within that 6 months.

Secondary outcome measures

To compare participants healthcare-related satisfaction through a questionnaire that will ask the participants at baseline and at 6 months how satisfied they are or have been with their AF care.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Kardia Mobile GroupExperimental Treatment1 Intervention

The intervention arm will be given a KardiaMobile device synched to their smartphone at the time of enrollment. They will be instructed on proper device procedure and will use the device with the onset of potential AF-related symptoms or when requested to do so by their healthcare provider. The device ECG recordings will be transmitted to participants physicians through MyChart who will incorporate this information into the patient's treatment as indicated. Healthcare utilization will be assessed by having the participants in both groups complete a questionnaire asking how many times they used their KardiaMobile device (if randomized to this group) and how many office appointments, emergency department visits, and hospital admissions they had within that six-month period.

Group II: Standard of Care GroupActive Control1 Intervention

The standard of care group will follow their routine care for their atrial fibrillation. Healthcare utilization will be assessed by having the participants in both groups complete a questionnaire asking how many times they used their KardiaMobile device (if randomized to this group) and how many office appointments, emergency department visits, and hospital admissions they had within that six-month period.

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Who is running the clinical trial?

Northwestern UniversityLead Sponsor

1,585 Previous Clinical Trials

917,131 Total Patients Enrolled

6 Trials studying Atrial Fibrillation

1,447 Patients Enrolled for Atrial Fibrillation

Cardiovascular Institute of the South Clinical Research CorporationOTHER

3 Previous Clinical Trials

123 Total Patients Enrolled

Media Library

Kardia Mobile 6L Device Clinical Trial Eligibility Overview. Trial Name: NCT05407415 — N/A

Atrial Fibrillation Research Study Groups: Kardia Mobile Group, Standard of Care Group

Atrial Fibrillation Clinical Trial 2023: Kardia Mobile 6L Device Highlights & Side Effects. Trial Name: NCT05407415 — N/A

Kardia Mobile 6L Device 2023 Treatment Timeline for Medical Study. Trial Name: NCT05407415 — N/A

Frequently Asked Questions

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

Is the age requirement for participation in this experiment limited to elderly individuals above 75?

"Prospective participants must be aged between 18-90 years old to qualify for this clinical trial. Additionally, 11 studies have been created specifically targeting those under the age of eighteen while 474 are tailored towards elderly patients above 65."

Answered by AI

How many individuals are enrolled in this clinical trial as of now?

"Indeed, according to clinicaltrials.gov the study is still recruiting participants; it was initially posted on September 1st 2022 and last updated at the end of that month. The research team require 100 individuals from a single hospital site."

Answered by AI

Is recruitment still open for this research project?

"Affirmatively, this study is accepting applications for participation. It was established on September 1st 2022 and its details were recently revised as of the 27th of that same month."

Answered by AI

What is the criteria to be admitted into this medical experiment?

"A total of 100 individuals with atrial fibrillation, aged 18 to 90 years old, are being enrolled in this study. To be eligible for enrollment they must satisfy the following criteria: between 18-90 years of age; diagnosed within 6 months; possessing a functioning smartphone and data plan; able to physically and mentally record reliable ECG readings on KardiaMobile device; have an estimated life expectancy over 12 months."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

KardiaMobile ECG Monitoring Effects on Health Care Utilization and Patient Experience With Atrial Fibrillation

Rod Passman 2022. "KardiaMobile ECG Monitoring Effects on Health Care Utilization and Patient Experience With Atrial Fibrillation". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05407415.