Personalized Voice Activated Wellness Assistants for Patients With Heart Failure

NCT03707275 | Completed

• 2 other identifiers: Alexa+ StudyUL1TR001409
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Heart Failure; Congestive Heart Failure

Keywords

Clinical trial; Patient-centered outcomes; Treatment of heart failure; Technology in heart failure

Outcome Measures

Primary Outcomes (1)

• Change in comfort level using Alexa+ technology as measured by the pre and post-test technology comfort survey

  3 months

Secondary Outcomes (2)

• 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

Study Arms (2)

Alexa+ Arm

EXPERIMENTAL

Device: Alexa+

Standard of Care Arm

OTHER

Other: Standard of Care Arm

Interventions

Alexa+ DEVICE

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.

Alexa+ Arm

Standard of Care Arm OTHER

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.

Standard of Care Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Participation in another interventional clinical trial

Sponsors & Collaborators

• Medstar Health Research Institute: lead
• National Institutes of Health (NIH): collaborator
• Georgetown-Howard Universities Center for Clinical and Translational Science: collaborator
• ObEN Artificial Intelligence: collaborator

Study Sites (1)

MedStar Washington Hospital Center

Washington D.C., District of Columbia, 20010, United States

Location

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Officials

• Nawar M Shara, M.S., PhD

  Medstar Health Research Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Department of Biostatistics and Biomedical Informatics

Study Record Dates

• First Submitted: October 2, 2018
• First Posted: October 16, 2018
• Study Start: December 10, 2018
• Primary Completion: October 31, 2019
• Study Completion: October 31, 2019
• Last Updated: June 19, 2020

Record last verified: 2020-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)