Patient Centered Mobile Health Technology Enabled Atrial Fibrillation Management

Atrial Fibrillation Clinical Trial

— mTECHAFib  

Official title:

Patient Centered Mobile Health Technology Enabled Atrial Fibrillation Management: A Pilot Randomized Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05400837
• Other study ID #: IRB00321575
• Status: Recruiting
• Phase: N/A
• Start date: June 26, 2023
• Est. completion date: August 30, 2024

Study information

• Verified date: June 2023
• Source: Johns Hopkins University
• Contact: David Spragg, MD
• Phone: 4105503204
• Email: dspragg1[@]jhmi.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: August 30, 2024
• Est. primary completion date: July 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria

• 18 years or older
• Non- valvular Paroxysmal Atrial Fibrillation diagnosed not more than 12 months prior to randomization Exclusion Criteria
• 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
• 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

Related Conditions & MeSH terms

• Atrial Fibrillation
• Behavior

Intervention

Combination Product:
• Corrie Virtual Atrial Fibrillation Management Program
Intervention aims to implement guideline-recommended Afib care

Locations

Country	Name	City	State
United States	Johns Hopkins University	Baltimore	Maryland

Sponsors (1)

Lead Sponsor	Collaborator
Johns Hopkins University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Feasibility as assessed by the retention rate	Retention rate at 3 months (number of individuals who continue study participation (defined by App interaction, Coaching call participation or follow up survey completion) divided by the number of individuals who consent to participation in the study at 3 months after enrollment.	12 weeks
Secondary	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.	12 weeks
Secondary	Atrial Fibrillation Severity as assessed by the Atrial Fibrillation Severity Scale	Measured by the Atrial Fibrillation Severity Scale (AFSS) - validated 19 item questionnaire.	12 weeks
Secondary	Social Support as assessed by the Medical Outcomes Social Support Survey Instrument	Measured by Medical Outcomes Social Support Survey Instrument (MOS Social Support Scale) - 19 item questionnaire with final score ranging between 0 - 100 with higher scores suggesting more support.	12 weeks
Secondary	Skills in applying electronic health information to health problems	Measured by 8-item questionnaire eHealth Literacy Scale.	12 weeks
Secondary	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).	12 weeks
Secondary	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.	12 weeks
Secondary	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.	12 weeks
Secondary	Atrial Fibrillation Episode Burden	As assessed by the ratio of the number of 30 second single lead electrocardiogram(ECG) recordings with Afib divided by total number of 30 second single lead ECG recordings.	12 weeks
Secondary	Physical Activity as assessed by the Rapid Assessment of Physical Activity	Physical Activity will be assessed by The Rapid Assessment of Physical Activity (RAPA).	12 weeks
Secondary	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.	12 weeks
Secondary	Smoking status as assessed by study team developed questionnaire	Smoking status will be assessed by a study team developed questionnaire.	12 weeks
Secondary	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: 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: You are making many healthy choices.	12 weeks
Secondary	Blood pressure	Measured in millimeters of mercury (mmHg).	12 weeks
Secondary	Body Mass Index (BMI)	Measured in kilograms over meter squared (Kg/m^2).	12 weeks