Personalized Voice Activated Wellness Assistants for Patients With Heart Failure

NCT ID: NCT03707275

Last Updated: 2020-06-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-12-10

Study Completion Date

2019-10-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Heart Failure Congestive Heart Failure

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Alexa+ Arm

Group Type EXPERIMENTAL

Alexa+

Intervention Type 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.

Standard of Care Arm

Group Type OTHER

Standard of Care Arm

Intervention Type 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.

Interventions

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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.

Intervention Type DEVICE

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.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Institutes of Health (NIH)

NIH

Sponsor Role collaborator

Georgetown-Howard Universities Center for Clinical and Translational Science

OTHER

Sponsor Role collaborator

ObEN Artificial Intelligence

UNKNOWN

Sponsor Role collaborator

Medstar Health Research Institute

OTHER

Sponsor Role lead

Responsible Party

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Nawar Shara

Director, Department of Biostatistics and Biomedical Informatics

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Nawar M Shara, M.S., PhD

Role: PRINCIPAL_INVESTIGATOR

Medstar Health Research Institute

Locations

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MedStar Washington Hospital Center

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

Site Status

Countries

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United States

Other Identifiers

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UL1TR001409

Identifier Type: NIH

Identifier Source: secondary_id

View Link

Alexa+ Study

Identifier Type: -

Identifier Source: org_study_id

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