Pilot Atrial Fibrillation Information Technology Trial
| Status: | Completed |
|---|---|
| Conditions: | Atrial Fibrillation |
| Therapuetic Areas: | Cardiology / Vascular Diseases |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 7/5/2018 |
| Start Date: | June 21, 2017 |
| End Date: | June 30, 2018 |
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.
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.
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.
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.
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.
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