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

NCT04050982 | Terminated Results FDA Device

• 1 other identifier: IRB# 48183
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 1

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.

Conditions

Atrial Fibrillation

Keywords

Text Messaging; Patient Education; Psychometric

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (4)

• Change From Baseline in Knowledge Related to Atrial Fibrillation

  Baseline, month 3, month 6, and month 12

• Change From Baseline in AF Quality of Life Score

  Baseline, month 3, month 6, and month 12

• Change From Baseline in AF Symptom Severity

  Baseline, month 3, month 6, and month 12

• Change From Baseline in AF Symptom Burden

  Baseline, month 3, month 6, and month 12

Study Arms (3)

Pilot Testing

EXPERIMENTAL

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

Device: AF CARE

AF CARE plus Usual Care

ACTIVE COMPARATOR

Patients will interface with the digital application.

Device: AF CARE; Behavioral: Usual Care

Usual Care then AF Care

ACTIVE COMPARATOR

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

Behavioral: Usual Care

Interventions

AF CARE DEVICE

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.

AF CARE plus Usual Care; Pilot Testing

Usual Care BEHAVIORAL

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

AF CARE plus Usual Care; Usual Care then AF Care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Stanford University: lead
• American Heart Association: collaborator
• PatientBond: collaborator

Study Sites (1)

Stanford Health Care

Stanford, California, 94305, United States

Location

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Limitations and Caveats

The study did not meet its planned enrollment size, and did not achieve statistical power.

Results Point of Contact

• Title: Linda Ottoboni
• Organization: Stanford University

LOttoboni@stanfordhealthcare.org

(650) 498-5914

Study Officials

• Linda Ottoboni, PhD

  Clinician and research scientist

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Stanford Electrophysiology and Arrhythmia Service

Model Details: Randomized control trial

Study Record Dates

• First Submitted: August 7, 2019
• First Posted: August 9, 2019
• Study Start: October 1, 2019
• Primary Completion: January 26, 2023
• Study Completion: January 26, 2023
• Last Updated: September 22, 2023
• Results First Posted: September 22, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)