Patient Centered Mobile Health Technology Enabled Atrial Fibrillation Management: A Pilot Randomized Clinical Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Johns Hopkins University
- Enrollment
- 61
- Locations
- 2
- Primary Endpoint
- Number of Participants Who Continue Study Participation at 12 Weeks
Study Overview
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).
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Supportive Care
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
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)
Secondary Outcomes
- Atrial Fibrillation (AF) Severity as Assessed by the Atrial Fibrillation Severity Scale(12 weeks)
- Stress Level as Assessed by the Perceived Stress Score(12 weeks)
- Quality of Life as Assessed by the Atrial Fibrillation Effect on Quality-of-Life(12 weeks)
- Depressive Symptoms as Assessed by the Patient Health Questionnaire 8(12 weeks)
- Alcohol Use as Assessed by the Alcohol Use Disorders Identification Test(12 weeks)
- Body Mass Index (BMI)(12 weeks)
- Physical Activity as Assessed by the Rapid Assessment of Physical Activity(12 weeks)
- Satisfaction With Intervention(12 weeks)
- Anxiety as Assessed by the Generalized Anxiety Disorder 7 Score(12 weeks)
- Diet as Assessed by the Rate Your Plate (RYP) Scale(12 weeks)
- Skills in Applying Electronic Health Information to Health Problems(12 weeks)
- Blood Pressure(12 weeks)
- Body Mass Index (BMI)(12 weeks)