Pilot Atrial Fibrillation Information Technology Trial

Not Applicable

Completed

• Conditions: Atrial Fibrillation
• Interventions: Behavioral: ECA/Kardia

• Registration Number: NCT03093558
• Lead Sponsor: University of Pittsburgh

Brief Summary

AF is associated with significant social and medical costs, including diminished quality of life (QOL) and increased health care utilization (HCU). This pilot study will enroll 200 adults with prevalent, non-valvular AF of ≤3 year's duration at University of Pittsburgh Medical Center (UPMC). The primary objective at present is to obtain extensive feasibility and pilot data in implementing the Embodied Conversational Agent (ECA) in concert with the Kardia (KAC) heart rhythm monitor.

Detailed Description

This pilot study is a single-center, two-arm randomized study that by design is unblinded. 200 total participants are planned. Each participant will be randomized in an unblocked manner to receive "usual care" or the ECA/KAC intervention. Participants will have study visits at baseline and time 30 days. Adherence to using the ECA/KAC in combination over 30 days will be quantified. Following participation study participants randomized to the ECA/KAC intervention will undergo an interview to determine their experience with the ECA/KAC. Participants and their physicians will receive a summary of ECA use and symptoms and correlated findings by KAC.

Study Timeline

• Study First Submitted: 2017-03-02
• Study First Submitted QC: 2017-03-22
• Study First Posted: 2017-03-28
• Study Start: 2017-06-21
• Primary Completion: 2018-06-20
• Study Completion: 2018-06-30
• Status Verified: 2020-10
• Last Update Submitted: 2020-10-28
• Last Update Posted: 2020-10-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

• CHADS2-VASc score ≥2; English-speaking (at level appropriate to provide informed consent and participate in this research protocol); no plan to relocate from the area within 12 months of enrollment

Exclusion Criteria

• AF that is due to non-cardiac causes (e.g., sepsis, pneumonia, thyroid disorders, and intoxication); AF within 30 days of any cardiothoracic or thoracic surgery; Inability to complete training session with the smartphone and demonstrate use of the ECA; Inability to answer specific protocol-based questions correctly during consent.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Intervention arm	ECA/Kardia	Receive the ECA/Kardia for 30-day use.

Primary Outcome Measures

Name	Time	Method
Daily adherence to the Embodied Conversational Agent and Kardia heart rhythm monitor	30 days	Assessment of daily use of the combined ECA and Kardia heart rate/rhythm monitor

Secondary Outcome Measures

Name	Time	Method
Participant experience of and response to using the ECA	30 days	Open- and close-ended questions regarding participant experience of the ECA and response to its use

Trial Locations

Locations (1)

University of Pittsburgh Medical Center; 🇺🇸 Pittsburgh, Pennsylvania, United States