Pilot Atrial Fibrillation Information Technology Trial

NCT03093558 | Completed

• 1 other identifier: PRO16020290
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

Atrial Fibrillation

Keywords

adherence; quality of life; health literacy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Participant experience of and response to using the ECA

  30 days

Study Arms (2)

Intervention arm

EXPERIMENTAL

Receive the ECA/Kardia for 30-day use.

Behavioral: ECA/Kardia

Usual care arm

NO INTERVENTION

Receive a journal for observation of adherence and symptoms.

Interventions

ECA/Kardia BEHAVIORAL

Use of the ECA and Kardia daily for 30 days.

Intervention arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Pittsburgh: lead

Study Sites (1)

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, 15213, United States

Location

Related Publications (3)

• Magnani JW, Schlusser CL, Kimani E, Rollman BL, Paasche-Orlow MK, Bickmore TW. The Atrial Fibrillation Health Literacy Information Technology System: Pilot Assessment. JMIR Cardio. 2017 Jul-Dec;1(2):e7. doi: 10.2196/cardio.8543. Epub 2017 Dec 12.

  PMID: 29473644 RESULT

• Guhl E, Althouse AD, Pusateri AM, Kimani E, Paasche-Orlow MK, Bickmore TW, Magnani JW. The Atrial Fibrillation Health Literacy Information Technology Trial: Pilot Trial of a Mobile Health App for Atrial Fibrillation. JMIR Cardio. 2020 Sep 4;4(1):e17162. doi: 10.2196/17162.

  PMID: 32886070 RESULT

• Guhl EN, Schlusser CL, Henault LE, Bickmore TW, Kimani E, Paasche-Orlow MK, Magnani JW. Rationale and design of the Atrial Fibrillation health Literacy Information Technology Trial: (AF-LITT). Contemp Clin Trials. 2017 Nov;62:153-158. doi: 10.1016/j.cct.2017.09.005. Epub 2017 Sep 18.

  PMID: 28923492 DERIVED

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Medicine

Study Record Dates

• First Submitted: March 2, 2017
• First Posted: March 28, 2017
• Study Start: June 21, 2017
• Primary Completion: June 20, 2018
• Study Completion: June 30, 2018
• Last Updated: October 30, 2020

Record last verified: 2020-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)