Feasibility Study to Improve AF Outcomes Using a Digital Application for CV Risk Reduction (AFCARE)
Primary Purpose
Atrial Fibrillation
Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
AF CARE
Usual Care
Sponsored by
About this trial
This is an interventional supportive care trial for Atrial Fibrillation focused on measuring Text Messaging, Patient Education, Psychometric
Eligibility Criteria
Inclusion Criteria:
- BMI > 28 kg/m2 AND one additional CVRF using LS7
- Access and willingness to engage in digital technology
- Has a valid email address and a cell phone number
- Able to ambulate
- Able to speak/read English
Exclusion Criteria:
- Class III/IV heart failure
- MI or cardiac surgery in prior 3 months
- Severe renal/hepatic disease
- Active malignancy
- Current/recent (within 6 months) enrollment in weight loss program
Sites / Locations
- Stanford Health Care
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Active Comparator
Active Comparator
Arm Label
Pilot Testing
AF CARE plus Usual Care
Usual Care then AF Care
Arm Description
Patients interface with the digital application, providing feedback on usability and satisfaction.
Patients will interface with the digital application.
After a 6 month period of usual care only, patients will interface with the digital application.
Outcomes
Primary Outcome Measures
Percentage of Text Messages That Were Reviewed
Percentage of Emails Opened and Clicked Through
Percentage of emails opened, and of those opened, the percentage of emails clicked through
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
Secondary Outcome Measures
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.
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.
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.
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.
Full Information
NCT ID
NCT04050982
First Posted
August 7, 2019
Last Updated
August 27, 2023
Sponsor
Stanford University
Collaborators
American Heart Association, PatientBond
1. Study Identification
Unique Protocol Identification Number
NCT04050982
Brief Title
Feasibility Study to Improve AF Outcomes Using a Digital Application for CV Risk Reduction
Acronym
AFCARE
Official Title
Feasibility Study to Improve Atrial Fibrillation Outcomes Using a Digital Application for Cardiovascular Risk Reduction: Precursor to a Multicenter Randomized Trial
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Terminated
Why Stopped
Acquisition of digital messaging company and decision made to withdraw study support
Study Start Date
October 1, 2019 (Actual)
Primary Completion Date
January 26, 2023 (Actual)
Study Completion Date
January 26, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Stanford University
Collaborators
American Heart Association, PatientBond
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Device Product Not Approved or Cleared by U.S. FDA
Yes
Data Monitoring Committee
No
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atrial Fibrillation
Keywords
Text Messaging, Patient Education, Psychometric
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomized control trial
Masking
None (Open Label)
Allocation
Randomized
Enrollment
11 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Pilot Testing
Arm Type
Experimental
Arm Description
Patients interface with the digital application, providing feedback on usability and satisfaction.
Arm Title
AF CARE plus Usual Care
Arm Type
Active Comparator
Arm Description
Patients will interface with the digital application.
Arm Title
Usual Care then AF Care
Arm Type
Active Comparator
Arm Description
After a 6 month period of usual care only, patients will interface with the digital application.
Intervention Type
Device
Intervention Name(s)
AF CARE
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Usual Care
Intervention Description
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
Primary Outcome Measure Information:
Title
Percentage of Text Messages That Were Reviewed
Time Frame
Baseline through month 6
Title
Percentage of Emails Opened and Clicked Through
Description
Percentage of emails opened, and of those opened, the percentage of emails clicked through
Time Frame
Baseline through month 6
Title
Cardiovascular Risk Factor Score
Description
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
Time Frame
Baseline, month 3, month 6, and month 12
Secondary Outcome Measure Information:
Title
Change From Baseline in Knowledge Related to Atrial Fibrillation
Description
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.
Time Frame
Baseline, month 3, month 6, and month 12
Title
Change From Baseline in AF Quality of Life Score
Description
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.
Time Frame
Baseline, month 3, month 6, and month 12
Title
Change From Baseline in AF Symptom Severity
Description
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.
Time Frame
Baseline, month 3, month 6, and month 12
Title
Change From Baseline in AF Symptom Burden
Description
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.
Time Frame
Baseline, month 3, month 6, and month 12
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
BMI > 28 kg/m2 AND one additional CVRF using LS7
Access and willingness to engage in digital technology
Has a valid email address and a cell phone number
Able to ambulate
Able to speak/read English
Exclusion Criteria:
Class III/IV heart failure
MI or cardiac surgery in prior 3 months
Severe renal/hepatic disease
Active malignancy
Current/recent (within 6 months) enrollment in weight loss program
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Linda Ottoboni, PhD
Organizational Affiliation
Clinician and research scientist
Official's Role
Principal Investigator
Facility Information:
Facility Name
Stanford Health Care
City
Stanford
State/Province
California
ZIP/Postal Code
94305
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
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Feasibility Study to Improve AF Outcomes Using a Digital Application for CV Risk Reduction
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