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Completed

NCT Number: NCT03093558

Pilot Atrial Fibrillation Information Technology Trial

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, 15213, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

ECA/Kardia

Behavioral

Use of the ECA and Kardia daily for 30 days.

Primary outcomes

  1. Daily adherence to the Embodied Conversational Agent and Kardia heart rhythm monitor

    Time frame: 30 days

    Assessment of daily use of the combined ECA and Kardia heart rate/rhythm monitor

Secondary outcomes

  1. Participant experience of and response to using the ECA

    Time frame: 30 days

    Open- and close-ended questions regarding participant experience of the ECA and response to its use

Sponsors and collaborators

Lead sponsor

University of Pittsburgh

Other

Registry information

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Mar 28, 2017
Registry last updated
Oct 30, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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