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Pilot Atrial Fibrillation Information Technology Trial

Primary Purpose

Atrial Fibrillation

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
ECA/Kardia
Sponsored by
University of Pittsburgh
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Atrial Fibrillation focused on measuring adherence, quality of life, health literacy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • University of Pittsburgh Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Intervention arm

Usual care arm

Arm Description

Receive the ECA/Kardia for 30-day use.

Receive a journal for observation of adherence and symptoms.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
March 2, 2017
Last Updated
October 28, 2020
Sponsor
University of Pittsburgh
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1. Study Identification

Unique Protocol Identification Number
NCT03093558
Brief Title
Pilot Atrial Fibrillation Information Technology Trial
Official Title
Pilot Atrial Fibrillation Information Technology Trial
Study Type
Interventional

2. Study Status

Record Verification Date
October 2020
Overall Recruitment Status
Completed
Study Start Date
June 21, 2017 (Actual)
Primary Completion Date
June 20, 2018 (Actual)
Study Completion Date
June 30, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Pittsburgh

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atrial Fibrillation
Keywords
adherence, quality of life, health literacy

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
120 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention arm
Arm Type
Experimental
Arm Description
Receive the ECA/Kardia for 30-day use.
Arm Title
Usual care arm
Arm Type
No Intervention
Arm Description
Receive a journal for observation of adherence and symptoms.
Intervention Type
Behavioral
Intervention Name(s)
ECA/Kardia
Intervention Description
Use of the ECA and Kardia daily for 30 days.
Primary Outcome Measure Information:
Title
Daily adherence to the Embodied Conversational Agent and Kardia heart rhythm monitor
Description
Assessment of daily use of the combined ECA and Kardia heart rate/rhythm monitor
Time Frame
30 days
Secondary Outcome Measure Information:
Title
Participant experience of and response to using the ECA
Description
Open- and close-ended questions regarding participant experience of the ECA and response to its use
Time Frame
30 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Facility Information:
Facility Name
University of Pittsburgh Medical Center
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
As this is a pilot study, IPD available by direct request to the PI.
Citations:
PubMed Identifier
29473644
Citation
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.
Results Reference
result
PubMed Identifier
32886070
Citation
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.
Results Reference
result
PubMed Identifier
28923492
Citation
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.
Results Reference
derived

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Pilot Atrial Fibrillation Information Technology Trial

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