Patient Centered Mobile Health Technology Enabled Atrial Fibrillation Management

Not Applicable

Completed

• Conditions: Atrial Fibrillation; Behavior
• Interventions: Combination Product: Corrie Virtual Atrial Fibrillation Management Program

• Registration Number: NCT05400837
• Lead Sponsor: Johns Hopkins University

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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-05-27
• Study First Submitted QC: 2022-05-27
• Study First Posted: 2022-06-02
• Study Start: 2023-06-26
• Primary Completion: 2024-05-23
• Study Completion: 2024-05-23
• Status Verified: 2024-06
• Last Update Submitted: 2024-06-17
• Last Update Posted: 2024-06-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 61

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Corrie Virtual Atrial Fibrillation Management Program	Corrie Virtual Atrial Fibrillation Management Program	Multicomponent virtual atrial fibrillation management program

Primary Outcome Measures

Name	Time	Method
Feasibility as assessed by the retention rate	12 weeks	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

Name	Time	Method
Quality of life as assessed by the Atrial Fibrillation Effect on Quality-of-Life	12 weeks	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.
Skills in applying electronic health information to health problems	12 weeks	Measured by 8-item questionnaire eHealth Literacy Scale.
Social Support as assessed by the Medical Outcomes Social Support Survey Instrument	12 weeks	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.
Smoking status as assessed by study team developed questionnaire	12 weeks	Smoking status will be assessed by a study team developed questionnaire.
Atrial Fibrillation Severity as assessed by the Atrial Fibrillation Severity Scale	12 weeks	Measured by the Atrial Fibrillation Severity Scale (AFSS) - validated 19 item questionnaire.
Physical Activity as assessed by the Rapid Assessment of Physical Activity	12 weeks	Physical Activity will be assessed by The Rapid Assessment of Physical Activity (RAPA).
Depressive symptoms as assessed by the Patient Health Questionnaire 8	12 weeks	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).
Alcohol use as assessed by the Alcohol Use Disorders Identification Test	12 weeks	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.
Body Mass Index (BMI)	12 weeks	Measured in kilograms over meter squared (Kg/m\^2).
Anxiety as assessed by the Generalized Anxiety Disorder 7 score	12 weeks	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	12 weeks	Measured by Perceived Stress Score (PSS-10), 10 item questionnaire where score ranges from 0-40 with higher scores indicating higher level of stress.
Diet as assessed by the Rate Your Plate (RYP) scale	12 weeks	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	12 weeks	Measured in millimeters of mercury (mmHg).

Trial Locations

Locations (1)

Johns Hopkins University; 🇺🇸 Baltimore, Maryland, United States