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

Stanford University

Status: Terminated

Conditions: Atrial Fibrillation

Treatments: Behavioral: Usual Care; Device: AF CARE

Study type: Interventional

Funder types: Other

Identifiers

NCT04050982

IRB# 48183

Details and patient eligibility

About

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.

Enrollment: 11 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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11 participants in 3 patient groups

Pilot Testing

Experimental group

Description:

Patients interface with the digital application, providing feedback on usability and satisfaction.

Treatment:

Device: AF CARE

AF CARE plus Usual Care

Active Comparator group

Description:

Patients will interface with the digital application.

Treatment:

Behavioral: Usual Care

Device: AF CARE

Usual Care then AF Care

Active Comparator group

Description:

After a 6 month period of usual care only, patients will interface with the digital application.

Treatment:

Behavioral: Usual Care