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Patient Centered Mobile Health Technology Enabled Atrial Fibrillation Management (mTECHAFib)

Primary Purpose

Atrial Fibrillation, Behavior

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Corrie Virtual Atrial Fibrillation Management Program
Sponsored by
Johns Hopkins University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Atrial Fibrillation focused on measuring Remote Patient Monitoring, Atrial Fibrillation, Risk Factor Modification, Digital Health, Mobile Health

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Johns Hopkins UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Corrie Virtual Atrial Fibrillation Management Program

Usual Care

Arm Description

Multicomponent virtual atrial fibrillation management program

Receives usual care. Usual care is defined as care according to the patients care team's standard practice

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
Atrial Fibrillation Severity as assessed by the Atrial Fibrillation Severity Scale
Measured by the Atrial Fibrillation Severity Scale (AFSS) - validated 19 item questionnaire.
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.
Skills in applying electronic health information to health problems
Measured by 8-item questionnaire eHealth Literacy Scale.
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).
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.
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.
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.
Physical Activity as assessed by the Rapid Assessment of Physical Activity
Physical Activity will be assessed by The Rapid Assessment of Physical Activity (RAPA).
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.
Smoking status as assessed by study team developed questionnaire
Smoking status will be assessed by a study team developed questionnaire.
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.
Blood pressure
Measured in millimeters of mercury (mmHg).
Body Mass Index (BMI)
Measured in kilograms over meter squared (Kg/m^2).

Full Information

First Posted
May 27, 2022
Last Updated
June 27, 2023
Sponsor
Johns Hopkins University
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1. Study Identification

Unique Protocol Identification Number
NCT05400837
Brief Title
Patient Centered Mobile Health Technology Enabled Atrial Fibrillation Management
Acronym
mTECHAFib
Official Title
Patient Centered Mobile Health Technology Enabled Atrial Fibrillation Management: A Pilot Randomized Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 26, 2023 (Actual)
Primary Completion Date
July 1, 2024 (Anticipated)
Study Completion Date
August 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Johns Hopkins University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

Brief 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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atrial Fibrillation, Behavior
Keywords
Remote Patient Monitoring, Atrial Fibrillation, Risk Factor Modification, Digital Health, Mobile Health

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Corrie Virtual Atrial Fibrillation Management Program
Arm Type
Experimental
Arm Description
Multicomponent virtual atrial fibrillation management program
Arm Title
Usual Care
Arm Type
No Intervention
Arm Description
Receives usual care. Usual care is defined as care according to the patients care team's standard practice
Intervention Type
Combination Product
Intervention Name(s)
Corrie Virtual Atrial Fibrillation Management Program
Intervention Description
Intervention aims to implement guideline-recommended Afib care
Primary Outcome Measure Information:
Title
Feasibility as assessed by the retention rate
Description
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.
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Quality of life as assessed by the Atrial Fibrillation Effect on Quality-of-Life
Description
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.
Time Frame
12 weeks
Title
Atrial Fibrillation Severity as assessed by the Atrial Fibrillation Severity Scale
Description
Measured by the Atrial Fibrillation Severity Scale (AFSS) - validated 19 item questionnaire.
Time Frame
12 weeks
Title
Social Support as assessed by the Medical Outcomes Social Support Survey Instrument
Description
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.
Time Frame
12 weeks
Title
Skills in applying electronic health information to health problems
Description
Measured by 8-item questionnaire eHealth Literacy Scale.
Time Frame
12 weeks
Title
Depressive symptoms as assessed by the Patient Health Questionnaire 8
Description
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).
Time Frame
12 weeks
Title
Anxiety as assessed by the Generalized Anxiety Disorder 7 score
Description
Generalized Anxiety Disorder 7 (GAD 7) - score ranges from 0 to 21 with higher scores indicating more anxiety.
Time Frame
12 weeks
Title
Stress level as assessed by the Perceived Stress Score
Description
Measured by Perceived Stress Score (PSS-10), 10 item questionnaire where score ranges from 0-40 with higher scores indicating higher level of stress.
Time Frame
12 weeks
Title
Atrial Fibrillation Episode Burden
Description
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.
Time Frame
12 weeks
Title
Physical Activity as assessed by the Rapid Assessment of Physical Activity
Description
Physical Activity will be assessed by The Rapid Assessment of Physical Activity (RAPA).
Time Frame
12 weeks
Title
Alcohol use as assessed by the Alcohol Use Disorders Identification Test
Description
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.
Time Frame
12 weeks
Title
Smoking status as assessed by study team developed questionnaire
Description
Smoking status will be assessed by a study team developed questionnaire.
Time Frame
12 weeks
Title
Diet as assessed by the Rate Your Plate (RYP) scale
Description
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.
Time Frame
12 weeks
Title
Blood pressure
Description
Measured in millimeters of mercury (mmHg).
Time Frame
12 weeks
Title
Body Mass Index (BMI)
Description
Measured in kilograms over meter squared (Kg/m^2).
Time Frame
12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
David Spragg, MD
Phone
4105503204
Email
dspragg1@jhmi.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Nino Isakadze, MD, MHS
Phone
4109555999
Email
nisakad1@jh.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David Spragg, MD
Organizational Affiliation
Johns Hopkins University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Johns Hopkins University
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21287
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
David Spragg
Phone
410-550-3204
Email
dspragg1@jhmi.edu

12. IPD Sharing Statement

Plan to Share IPD
No

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Patient Centered Mobile Health Technology Enabled Atrial Fibrillation Management

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