Personalized Voice Activated Wellness Assistants for Patients With Heart Failure

Heart Failure Clinical Trial

Official title:

Personalized Voice Activated Wellness Assistants for Patients With Heart Failure

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03707275
• Other study ID #: Alexa+ Study
• Secondary ID: UL1TR001409
• Status: Completed
• Phase: N/A
• Start date: December 10, 2018
• Est. completion date: October 31, 2019

Study information

• Verified date: June 2020
• Source: Medstar Health Research Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: October 31, 2019
• Est. primary completion date: October 31, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Congestive Heart Failure
• Heart Failure

Intervention

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
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.

Locations

Country	Name	City	State
United States	MedStar Washington Hospital Center	Washington	District of Columbia

Sponsors (4)

Lead Sponsor	Collaborator
Medstar Health Research Institute	Georgetown-Howard Universities Center for Clinical and Translational Science, National Institutes of Health (NIH), ObEN Artificial Intelligence

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in comfort level using Alexa+ technology as measured by the pre and post-test technology comfort survey		3 months
Secondary	Change in number of hospitalizations as measured by hospitalization data extracted from the EHR		3 months
Secondary	Change in medication adherence as measured by number of prescriptions filled extracted from the EHR		3 months