Personalized Voice Activated Wellness Assistants for Patients With Heart Failure

The Alexa+ Study will compare the use of the Amazon Echo Dot with Alexa voice technology in patients with chronic heart failure to those receiving standard of care heart failure management on changes in health and patient-centered outcomes.

Study Overview

• Status: Completed
• Conditions: Heart Failure; Congestive Heart Failure
• Intervention / Treatment: Device: Alexa+; Other: Standard of Care Arm

Detailed Description

Integrating data from virtual voice activated assistants (Amazon Echo Dot with Alexa voice technology), with the rich medical history available in Electronic Health Records (EHR) will allow a truly customized, interactive, and automated personal healthcare assistant. This technology will be validated in patients who have chronic heart failure (HF). Half of the study patients will receive an Amazon Echo Dot (Alexa) enhanced with a HF Care custom Alexa Skill that is patient-specific, or Alexa+. Data on patient interactions with the device will be followed for three months. The control groups will receive standard of care (SOC) HF management. Both study and control groups will receive regular follow up from the HF nurse and data from all hospital or clinic visits will be captured from the EHR.

• Study Type: Interventional
• Enrollment (Actual): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • District of Columbia
    • Washington, District of Columbia, United States, 20010
      • MedStar Washington Hospital Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Heart failure patients seen at the MedStar heart failure clinic and the MedStar Washington Hospital Center inpatient heart failure service
• At least 18 years of age
• Have access to in-home Wi-Fi

Exclusion Criteria:

• Participation in another interventional clinical trial

Study Plan

How is the study designed?

Design Details

• Primary Purpose: OTHER
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Alexa+ Arm	Device: Alexa+; Patients will receive the Amazon Echo Dot with Alexa voice technology (Alexa+) and will be asked to interact with the device for 3 months. Alexa+ will ask a series of questions. Based on the answers to these questions, it will either contact a study coordinator or will ask patients to take a specific action (such as weighing themselves). Data from this simple intervention will be merged with data extracted from the patient's health record and analyzed for clinical variables and demographics that are most predictive for success in use of these technologies.
OTHER: Standard of Care Arm	Other: Standard of Care Arm; This group will receive standard of care (SOC) HF management, which will entail regular follow up from the HF nurse and data from all hospital or clinic visits will be captured from the EHR.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Change in comfort level using Alexa+ technology as measured by the pre and post-test technology comfort survey	3 months

Secondary Outcome Measures

Outcome Measure	Time Frame
Change in number of hospitalizations as measured by hospitalization data extracted from the EHR	3 months
Change in medication adherence as measured by number of prescriptions filled extracted from the EHR	3 months

Collaborators and Investigators

• Sponsor: Medstar Health Research Institute
• Collaborators: National Institutes of Health (NIH); Georgetown-Howard Universities Center for Clinical and Translational Science; ObEN Artificial Intelligence
• Investigators: Principal Investigator: Nawar M Shara, M.S., PhD, MedStar Health Research Institute

Study record dates

Study Major Dates

• Study Start (ACTUAL): December 10, 2018
• Primary Completion (ACTUAL): October 31, 2019
• Study Completion (ACTUAL): October 31, 2019

Study Registration Dates

• First Submitted: October 2, 2018
• First Submitted That Met QC Criteria: October 12, 2018
• First Posted (ACTUAL): October 16, 2018

Study Record Updates

• Last Update Posted (ACTUAL): June 19, 2020
• Last Update Submitted That Met QC Criteria: June 18, 2020
• Last Verified: June 1, 2020

More Information

Terms related to this study

• Keywords: Clinical trial; Patient-centered outcomes; Treatment of heart failure; Technology in heart failure
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Heart Failure
• Other Study ID Numbers: Alexa+ Study; UL1TR001409 (NIH)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: The findings from this study will be disseminated through formal presentations and informal frequent communications with participants in this study. Results will be presented at a national meeting and a report to document the results of the pre-and-post questionnaires as well as the data generated from Alexa will also be shared with researchers as appropriate.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No