- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04050982
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
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Linda K Ottoboni, PhD
- Phone Number: 650-498-5914
- Email: lottoboni@stanfordhealthcare.org
Study Locations
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California
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Stanford, California, United States, 94305
- Stanford Health Care
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: Pilot Testing
Patients interface with the digital application, providing feedback on usability and satisfaction.
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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.
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Active Comparator: AF CARE plus Usual Care
Patients will interface with the digital application.
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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.
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
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Active Comparator: Usual Care then AF Care
After a 6 month period of usual care only, patients will interface with the digital application.
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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
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Percentage of Text Messages That Were Reviewed
Time Frame: Baseline through month 6
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Baseline through month 6
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Percentage of Emails Opened and Clicked Through
Time Frame: Baseline through month 6
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Percentage of emails opened, and of those opened, the percentage of emails clicked through
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Baseline through month 6
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Cardiovascular Risk Factor Score
Time Frame: Baseline, month 3, month 6, and month 12
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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
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Baseline, month 3, month 6, and month 12
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change From Baseline in Knowledge Related to Atrial Fibrillation
Time Frame: Baseline, month 3, month 6, and month 12
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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.
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Baseline, month 3, month 6, and month 12
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Change From Baseline in AF Quality of Life Score
Time Frame: Baseline, month 3, month 6, and month 12
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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.
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Baseline, month 3, month 6, and month 12
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Change From Baseline in AF Symptom Severity
Time Frame: Baseline, month 3, month 6, and month 12
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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.
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Baseline, month 3, month 6, and month 12
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Change From Baseline in AF Symptom Burden
Time Frame: Baseline, month 3, month 6, and month 12
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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.
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Baseline, month 3, month 6, and month 12
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Linda Ottoboni, PhD, Clinician and research scientist
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- IRB# 48183
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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