Feasibility Study to Improve AF Outcomes Using a Digital Application for CV Risk Reduction (AFCARE)

Feasibility Study to Improve Atrial Fibrillation Outcomes Using a Digital Application for Cardiovascular Risk Reduction: Precursor to a Multicenter Randomized Trial

The pilot portion of this study is to determine the feasibility of utilizing AF CARE to provide lifestyle modification support to patients with atrial fibrillation (AF).

The prospective, RCT portion of this study compare cardiovascular risk factors (CVRF), AF knowledge, AF Symptom Severity and Burden, and QOL between and within the wait list group and the AF CARE group at baseline, 3, 6, and 12 months.

Study Overview

• Status: Terminated
• Conditions: Atrial Fibrillation
• Intervention / Treatment: Device: AF CARE; Behavioral: Usual Care

• Study Type: Interventional
• Enrollment (Actual): 11
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Stanford, California, United States, 94305
      • Stanford Health Care

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. BMI > 28 kg/m2 AND one additional CVRF using LS7
2. Access and willingness to engage in digital technology
3. Has a valid email address and a cell phone number
4. Able to ambulate
5. Able to speak/read English

Exclusion Criteria:

1. Class III/IV heart failure
2. MI or cardiac surgery in prior 3 months
3. Severe renal/hepatic disease
4. Active malignancy
5. Current/recent (within 6 months) enrollment in weight loss program

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Pilot Testing; Patients interface with the digital application, providing feedback on usability and satisfaction.	Device: AF CARE; Patients will receive personalized messages twice weekly that will include behavior recommendations for CVRF reduction and AF education based on the initially entered psychographic profile and data entered.
Active Comparator: AF CARE plus Usual Care; Patients will interface with the digital application.	Device: AF CARE; Patients will receive personalized messages twice weekly that will include behavior recommendations for CVRF reduction and AF education based on the initially entered psychographic profile and data entered.; Behavioral: Usual Care; Participants will be given recommendations for CVRF reduction based on their initial American Heart Association Life Simple 7 (LS7) assessment and will be provided educational materials and be wait listed for digital app 3 months later
Active Comparator: Usual Care then AF Care; After a 6 month period of usual care only, patients will interface with the digital application.	Behavioral: Usual Care; Participants will be given recommendations for CVRF reduction based on their initial American Heart Association Life Simple 7 (LS7) assessment and will be provided educational materials and be wait listed for digital app 3 months later

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Text Messages That Were Reviewed		Baseline through month 6
Percentage of Emails Opened and Clicked Through	Percentage of emails opened, and of those opened, the percentage of emails clicked through	Baseline through month 6
Cardiovascular Risk Factor Score	The American Heart Association Life Simple 7 (LS7) is a calculated score using lab values, biometric measurements, and patient dietary responses. Score range: 0 to 10; 0 = most risk, 10 = least risk	Baseline, month 3, month 6, and month 12

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change From Baseline in Knowledge Related to Atrial Fibrillation	AF knowledge assessed with the Jessa AF Knowledge Score calculated from a 16 question self- reported questionnaire with a scoring range from 0-16, 16 indicating greater knowledge.	Baseline, month 3, month 6, and month 12
Change From Baseline in AF Quality of Life Score	Quality of Life assessed using a patient completed questionnaire, Atrial Fibrillation Effect on Quality of Life Questionnaire (AFEQT). The AFEQT score is a combined score of 21 items; overall score range is 21 to 100, with a higher score representing greater QOL.	Baseline, month 3, month 6, and month 12
Change From Baseline in AF Symptom Severity	AF symptom severity assessed with the Atrial Fibrillation Symptoms Severity Scale (AFSS). The AFSS is a patient self-reported questionnaire that contains 21 questions, with 7 questions that provide calculated scores for AF symptom severity (0-35) with higher scores representing greater severity.	Baseline, month 3, month 6, and month 12
Change From Baseline in AF Symptom Burden	AF symptom burden assessed with the Atrial Fibrillation Symptom Severity Scale. The AFSS is a patient self-reported questionnaire that contains 21 questions that provides calculated scores for AF Burden, calculated in the following manner; AF Burden = AF frequency + AF duration + AF severity. Each of the 3 measures contribute equally to the AF burden score, and each measure ranges from 1-10 to yield Total AF Burden scores ranging from 3-30. Higher scores indicate greater AF burden.	Baseline, month 3, month 6, and month 12

Collaborators and Investigators

• Sponsor: Stanford University
• Collaborators: American Heart Association; PatientBond
• Investigators: Principal Investigator: Linda Ottoboni, PhD, Clinician and research scientist

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2019
• Primary Completion (Actual): January 26, 2023
• Study Completion (Actual): January 26, 2023

Study Registration Dates

• First Submitted: August 7, 2019
• First Submitted That Met QC Criteria: August 7, 2019
• First Posted (Actual): August 9, 2019

Study Record Updates

• Last Update Posted (Actual): September 22, 2023
• Last Update Submitted That Met QC Criteria: August 27, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Keywords: Patient Education; Text Messaging; Psychometric
• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac; Atrial Fibrillation
• Other Study ID Numbers: IRB# 48183

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes