248 Participants Needed

Mobile Health Technology for Atrial Fibrillation

(mTECH Afib Trial)

Recruiting at 1 trial location
NI
Overseen ByNino Isakadze
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Johns Hopkins University
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

Trial Summary

What is the purpose of this trial?

The overall objective of this proposal is to evaluate the effect on quality of life of a comprehensive digital atrial fibrillation (AFib) management tool that will empower patients to a) take an active role in learning about AFib management options, starting and adhering to evidence-based therapies and lifestyle changes and b) to guide the patients during AFib episodes which are associated with anxiety and impairment in quality of life.Researchers plan to evaluate the effectiveness of this novel digital toolkit in improving quality of life and decreasing AFib burden in a randomized clinical trial (RCT). A pilot study assessing feasibility and retention of the intervention was previously conducted (NCT05400837)

Research Team

DS

David Spragg, MD

Principal Investigator

Johns Hopkins University

Eligibility Criteria

This trial is for adults aged 18 or older who have been diagnosed with paroxysmal (AFib lasting less than 7 days) or persistent atrial fibrillation (lasting 7 days or longer), and have a BMI of 27.0 or higher.

Inclusion Criteria

My BMI is 27 or higher.
I am 18 years old or older.
I have been diagnosed with atrial fibrillation that lasts for a short or long period.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants use a comprehensive digital atrial fibrillation management tool to learn about AFib management options and adhere to therapies and lifestyle changes

6 months
Virtual visits as needed

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

  • Corrie Virtual Atrial Fibrillation Management Program
Trial Overview The study is testing the Corrie Virtual Atrial Fibrillation Management Program, which aims to help patients manage AFib by educating them on treatment options, promoting adherence to therapies, guiding during AF episodes, and improving overall quality of life.
Participant Groups
2Treatment groups
Experimental Treatment
Active Control
Group I: Corrie Virtual Atrial Fibrillation Management ProgramExperimental Treatment1 Intervention
Multicomponent virtual atrial fibrillation management program
Group II: Usual CareActive Control1 Intervention
Receives usual care. Usual care is defined as care according to the patients care team's standard practice

Find a Clinic Near You

Who Is Running the Clinical Trial?

Johns Hopkins University

Lead Sponsor

Trials
2,366
Recruited
15,160,000+

Apple Inc.

Industry Sponsor

Trials
24
Recruited
1,792,000+

PhRMA Foundation

Collaborator

Trials
2
Recruited
350+

Itamar-Medical, Israel

Industry Sponsor

Trials
17
Recruited
2,900+

Pharmaceutical Research & Manufacturers Of America Foundation

Collaborator

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