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Behavioural Intervention
Mobile Health Technology for Atrial Fibrillation (mTECHAFib Trial)
N/A
Recruiting
Led By David Spragg, MD
Research Sponsored by Johns Hopkins University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Non-valvular Paroxysmal Atrial Fibrillation diagnosed not more than 12 months prior to randomization
18 years or older
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 weeks
Awards & highlights
mTECHAFib Trial Summary
This trial will test a new digital toolkit to help manage atrial fibrillation and improve quality of life.
Who is the study for?
This trial is for adults over 18 with a recent diagnosis of non-valvular Paroxysmal Atrial Fibrillation. It's not suitable for those with certain heart conditions, physical or mental impairments that prevent using technology, severe hypertension, visual/hearing issues, or a history of serious cardiac events.Check my eligibility
What is being tested?
The study tests the Corrie Virtual Atrial Fibrillation Management Program—a digital tool designed to help patients manage AFib by educating them and guiding them during episodes. The program aims to improve quality of life and reduce AFib burden in a pilot randomized clinical trial.See study design
What are the potential side effects?
Since this intervention involves a digital management tool rather than medication, traditional side effects are not applicable. However, users may experience stress or frustration if they encounter difficulties using the technology.
mTECHAFib Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I was diagnosed with a type of irregular heartbeat not caused by heart valve issues within the last year.
Select...
I am 18 years old or older.
mTECHAFib Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 12 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 weeks
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Feasibility as assessed by the retention rate
Secondary outcome measures
Alcohol use as assessed by the Alcohol Use Disorders Identification Test
Anxiety as assessed by the Generalized Anxiety Disorder 7 score
Atrial Fibrillation Episode Burden
+11 moremTECHAFib Trial Design
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
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Who is running the clinical trial?
Johns Hopkins UniversityLead Sponsor
2,245 Previous Clinical Trials
14,816,006 Total Patients Enrolled
11 Trials studying Atrial Fibrillation
7,549 Patients Enrolled for Atrial Fibrillation
David Spragg, MDPrincipal InvestigatorJohns Hopkins University
2 Previous Clinical Trials
260 Total Patients Enrolled
2 Trials studying Atrial Fibrillation
260 Patients Enrolled for Atrial Fibrillation
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I was diagnosed with a type of irregular heartbeat not caused by heart valve issues within the last year.I had a heart procedure that didn't fully restore blood flow.I have an untreated severe heart block.Your heart is not pumping enough blood.I am mentally capable of following the study's procedures.I do not speak English.I have atrial fibrillation with a resting heart rate over 110.I have had open-heart surgery before.I have been diagnosed with aortic dissection.You have trouble seeing or hearing and cannot use technology.I have been diagnosed with mitral stenosis.I have a heart condition that blocks blood flow and my test shows a specific heart pressure is high.I have been diagnosed with severe depression.I have fallen at least once in the past year.I have a serious heart valve problem.I have a history of cardiac arrest or sudden death.I have had heart complications such as shock, heart failure, or chest pain after a heart attack or surgery.I can use technology and exercise safely without my physical condition getting in the way.My blood pressure is not higher than 200/110 mmHg.I am 18 years old or older.You have a medical device implanted in your heart.You have an artificial heart valve.
Research Study Groups:
This trial has the following groups:- Group 1: Corrie Virtual Atrial Fibrillation Management Program
- Group 2: Usual Care
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there any vacancies to enroll in this scientific experiment?
"Unfortunately, clinicaltrials.gov indicates that this trial is no longer recruiting patients; the first posting was made on January 15th 2023 and the most recent edit to the page occured November 16th 2022. However, there are still 497 other trials actively collecting participants at present."
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