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

Atrial Fibrillation Clinical Trial

— AFCARE  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04050982
• Other study ID #: IRB# 48183
• Status: Terminated
• Phase: N/A
• Start date: October 1, 2019
• Est. completion date: January 26, 2023

Study information

• Verified date: August 2023
• Source: Stanford University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 11
• Est. completion date: January 26, 2023
• Est. primary completion date: January 26, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Atrial Fibrillation

Intervention

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

Locations

Country	Name	City	State
United States	Stanford Health Care	Stanford	California

Sponsors (3)

Lead Sponsor	Collaborator
Stanford University	American Heart Association, PatientBond

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Text Messages That Were Reviewed		Baseline through month 6
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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