Atrial FibrillationmTECHAFibNCT05400837
Patient Centered Mobile Health Technology Enabled Atrial Fibrillation Management
A study testing Corrie Virtual Atrial Fibrillation Management Program in people with Atrial Fibrillation and Behavior, run by Johns Hopkins University at 1 site in United States.
Trial summary
The overall objective of this proposal is to evaluate the feasibility 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atrial Fibrillation, Behavior
- What is being tested?
- Corrie Virtual Atrial Fibrillation Management Program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 61 participants
- Where
- 1 siteUnited States
- Study dates
- 26 Jun 2023to 23 May 2024
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 years or older
- Non- valvular Paroxysmal Atrial Fibrillation
Who cannot join
- Non-English speaking
- Has previously been evaluated by a cardiologist or electrophysiologist
- Mitral Stenosis
- Presence of Artificial Heart Valve
- Severe valvular disease (any)
- Physical disability that would preclude technology use, safe and adequate exercise performance
Show all 23Show fewer
- Hearing or Visual Impairment that would preclude technology use
- History of fall one or more times in the last year
- Hypertrophic obstructive cardiomyopathy with peak resting left ventricular outflow gradient of >25 mmHg
- Known aortic dissection
- Severe resting arterial hypertension (SBP >200 mmHg or diastolic BP >110mmHg) upon enrollment (obtained during clinic visit)
- Mental impairment leading to inability to cooperate with study procedures
- Untreated high degree atrioventricular block
- Atrial fibrillation with rapid ventricular rate (Resting heart rate at enrollment visit >110) upon enrollment (obtained during clinic visit)
- History of cardiac arrest, sudden death
- MI or cardiac surgery complications of cardiogenic shock and/or congestive heart failure (CHF) and/or signs/symptoms of post-procedure ischemia
- Left ventricular ejection fraction <40%
- Clinically significant depression
- Presence of implanted cardiac device
- Incomplete revascularization procedure
- Pregnancy
- Previous open-heart surgery
- Unsafe to participate in the program as per treating clinician
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Patient Centered Mobile Health Technology Enabled Atrial Fibrillation Management: A Pilot Randomized Clinical Trial
The overall objective of this proposal is to evaluate the feasibility 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 feasibility and preliminary efficacy of this novel digital toolkit in improving quality of life and decreasing AFib burden in a pilot randomized clinical trial (RCT).
- Conditions
- Atrial Fibrillation, Behavior
- Being tested
- Corrie Virtual Atrial Fibrillation Management Program
- Keywords
- Remote Patient Monitoring, Atrial Fibrillation, Risk Factor Modification, Digital Health, Mobile Health
- Medical subject headings
- Atrial Fibrillation, Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Corrie Virtual Atrial Fibrillation Management ProgramCombination product
Intervention aims to implement guideline-recommended Afib care
| Study group | Role | What they receive |
|---|---|---|
| Corrie Virtual Atrial Fibrillation Management Program | Experimental | Multicomponent virtual atrial fibrillation management program Receives: Combination Product: Corrie Virtual Atrial Fibrillation Management Program |
| Usual Care | No intervention | Receives usual care. Usual care is defined as care according to the patients care team's standard practice |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants Who Continue Study Participation at 12 Weeks
Feasibility assessed by retention at 12 weeks (number of individuals who continue study participation (defined by App interaction, Coaching call participation or follow up survey completion)
Measured: 12 weeks
Secondary outcomes (12)
Quality of Life as Assessed by the Atrial Fibrillation Effect on Quality-of-Life
Measured by Atrial Fibrillation Effect on Quality-of-Life (AFEQT), which consists of 20 items. Score ranges from 0 to 100 with higher scores signifying better quality of life.
Measured: 12 weeks
Atrial Fibrillation (AF) Severity as Assessed by the Atrial Fibrillation Severity Scale
Measured by the Atrial Fibrillation Severity Scale (AFSS) - validated 19 item questionnaire. Includes 5 subscores. AF burden is the sum of AF duration, AF severity, and AF frequency, and ranges from 3 to 30, with 30 being highest burden. AF duration, severity, and frequency each range from 1 to 10. The final subscore is AF symptoms, which ranges from 0-35 with 35 indicating worst possible symptoms.
Measured: 12 weeks
Skills in Applying Electronic Health Information to Health Problems
Measured by 8-item questionnaire eHealth Literacy Scale. Scores range from 10-50 with a higher score indicating higher electronic health literacy.
Measured: 12 weeks
Depressive Symptoms as Assessed by the Patient Health Questionnaire 8
Measured by Patient Health Questionnaire 8 (PHQ - 8) - 8-item measure with (≤4: no depressive symptom, 5-9: mild, ≥10: moderate to severe depressive symptoms). Score range 0-27 with higher score indicating more depressive symptoms.
Measured: 12 weeks
Anxiety as Assessed by the Generalized Anxiety Disorder 7 Score
Generalized Anxiety Disorder 7 (GAD 7) - score ranges from 0 to 21 with higher scores indicating more anxiety.
Measured: 12 weeks
Stress Level as Assessed by the Perceived Stress Score
Measured by Perceived Stress Score (PSS-10), 10 item questionnaire where score ranges from 0-40 with higher scores indicating higher level of stress.
Measured: 12 weeks
Physical Activity as Assessed by the Rapid Assessment of Physical Activity
Physical Activity will be assessed by The Rapid Assessment of Physical Activity (RAPA). Part 1 scores range from 1-5 with increasing scores indicating higher levels of activity, 5 being optimal. Part 2 is scored from 0-3 and measures the amount of flexibility and calisthenics exercise a person completes, with 3 being optimal.
Measured: 12 weeks
Alcohol Use as Assessed by the Alcohol Use Disorders Identification Test
As assessed by The Alcohol Use Disorders Identification Test (AUDIT), 10-item questionnaire. The score range is from 0 to 40 with 0 referring to abstainer with no history of alcohol abuse and higher scores indicate gradually higher and hazardous alcohol dependence.
Measured: 12 weeks
Diet as Assessed by the Rate Your Plate (RYP) Scale
Measured by Rate Your Plate (RYP) scale. A 27 item scale administered at 12 weeks with the following scoring system: Score ranges from 27-81.
Score of 27-45: There are many ways you can make your eating habits healthier. 46-63: There are some ways you can make your eating habits healthier. 64-81: Higher score indicates participant is making many healthy choices.
Measured: 12 weeks
Blood Pressure
Measured in millimeters of mercury (mmHg).
Measured: 12 weeks
Body Mass Index (BMI)
Measured in kilograms over meter squared (Kg/m^2).
Measured: 12 weeks
Satisfaction With Intervention
Measured by the System Usability Scale (SUS), modified for the intervention. The SUS score ranges from 0-100, where 0 is "worst imaginable" and 100 is "best imaginable." The average score is 68.0, a good score is between 71.4-85.4. 85.5 and above is considered excellent. Higher score more satisfaction.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2022
- Study start26 Jun 2023
- Primary completion23 May 2024
- Study completion23 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Atrial FibrillationStudies of the same condition, open and under way.
- More trials run by Johns Hopkins UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 61 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- David Spragg, MD, Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05400837
- Sponsor's protocol ID
- IRB00321575
- Acronym
- mTECHAFib
- Status last verified
- Jun 2025
- First submitted
- 27 May 2022
- Last updated
- 3 Jul 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Patient Centered Mobile Health Technology Enabled Atrial Fibrillation Management: A Pilot Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT05400837
- Acronym / sponsor ID
- mTECHAFib / IRB00321575
- Conditions
- Atrial Fibrillation, Behavior
- Keywords
- Remote Patient Monitoring, Atrial Fibrillation, Risk Factor Modification, Digital Health, Mobile Health
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 61 participants (actual)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Study start
- 26 Jun 2023 (actual)
- Primary completion
- 23 May 2024 (actual)
- Study completion
- 23 May 2024 (actual)
- First posted
- 2 Jun 2022 (actual)
- Results
- Posted 3 Jul 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The overall objective of this proposal is to evaluate the feasibility 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 feasibility and preliminary efficacy of this novel digital toolkit in improving quality of life and decreasing AFib burden in a pilot randomized clinical trial (RCT).
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Corrie Virtual Atrial Fibrillation Management Program | Experimental | Combination Product: Corrie Virtual Atrial Fibrillation Management ProgramMulticomponent virtual atrial fibrillation management program |
| Usual Care | No intervention | –Receives usual care. Usual care is defined as care according to the patients care team's standard practice |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 18 years or older
- Non- valvular Paroxysmal Atrial Fibrillation
Key exclusion criteria (23 listed)
- Non-English speaking
- Has previously been evaluated by a cardiologist or electrophysiologist
- Mitral Stenosis
- Presence of Artificial Heart Valve
- Severe valvular disease (any)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Corrie Virtual Atrial Fibrillation Management ProgramIntervention aims to implement guideline-recommended Afib care | Combination product | Corrie Virtual Atrial Fibrillation Management Program |
Primary outcome
Number of Participants Who Continue Study Participation at 12 Weeks
Time frame: 12 weeks
Feasibility assessed by retention at 12 weeks (number of individuals who continue study participation (defined by App interaction, Coaching call participation or follow up survey completion)
12 secondary outcomes
Quality of Life as Assessed by the Atrial Fibrillation Effect on Quality-of-Life
Time frame: 12 weeks
Atrial Fibrillation (AF) Severity as Assessed by the Atrial Fibrillation Severity Scale
Time frame: 12 weeks
Skills in Applying Electronic Health Information to Health Problems
Time frame: 12 weeks
Depressive Symptoms as Assessed by the Patient Health Questionnaire 8
Time frame: 12 weeks
Anxiety as Assessed by the Generalized Anxiety Disorder 7 Score
Time frame: 12 weeks
Stress Level as Assessed by the Perceived Stress Score
Time frame: 12 weeks
Physical Activity as Assessed by the Rapid Assessment of Physical Activity
Time frame: 12 weeks
Alcohol Use as Assessed by the Alcohol Use Disorders Identification Test
Time frame: 12 weeks
Diet as Assessed by the Rate Your Plate (RYP) Scale
Time frame: 12 weeks
Blood Pressure
Time frame: 12 weeks
Body Mass Index (BMI)
Time frame: 12 weeks
Satisfaction With Intervention
Time frame: 12 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jul 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
Related trials for Atrial Fibrillation
Active, not recruiting
Horizon 360 Protocol for the Treatment of Paroxysmal Atrial Fibrillation With the Sphere-360™ Catheter and Affera™ Mapping and Ablation System (Horizon 360)
Paroxysmal AF
Active, not recruitingObservational study
Concomitant Left Atrial Appendage Closure and Pulsed Field Ablation-Asia
Concomitant Procedures, Atrial Fibrillation
Active, not recruiting
CONVERGE Post-Approval Study (PAS)
Chronic Atrial Fibrillation
Recruiting
Early Closure of Left Atrial Appendage for Patients With Atrial Fibrillation and Ischemic Stroke Despite Anticoagulation Therapy
Ischemic Stroke, Atrial Fibrillation
RecruitingPhase 2
Safety in Adult Participants With Atrial Fibrillation Who Are Treated With Anticoagulation
Atrial Fibrillation (AF)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David Spragg, MD principal investigator
Johns Hopkins University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Corrie Virtual Atrial Fibrillation Management Program in people with Atrial Fibrillation and Behavior, run by Johns Hopkins University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 3 Jul 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants Who Continue Study Participation at 12 Weeks (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jul 2025.