Pilot Atrial Fibrillation Information Technology Trial

Study Overview
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Brief Summary
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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
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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.

Official Title
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Pilot Atrial Fibrillation Information Technology Trial

Conditions
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Atrial Fibrillation

Intervention / Treatment
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* Behavioral: ECA/Kardia


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention arm<br>Receive the ECA/Kardia for 30-day use. | Behavioral: ECA/Kardia<br>* Use of the ECA and Kardia daily for 30 days.<br>|
| No Intervention: Usual care arm<br>Receive a journal for observation of adherence and symptoms. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Daily adherence to the Embodied Conversational Agent and Kardia heart rhythm monitor | Assessment of daily use of the combined ECA and Kardia heart rate/rhythm monitor | 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Participant experience of and response to using the ECA | Open- and close-ended questions regarding participant experience of the ECA and response to its use | 30 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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adherence, quality of life, health literacy