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Personalized Voice Activated Wellness Assistants for Patients With Heart Failure

Primary Purpose

Heart Failure, Congestive Heart Failure

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Alexa+
Standard of Care Arm
Sponsored by
Medstar Health Research Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Heart Failure focused on measuring Clinical trial, Patient-centered outcomes, Treatment of heart failure, Technology in heart failure

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • MedStar Washington Hospital Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

Alexa+ Arm

Standard of Care Arm

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Change in number of hospitalizations as measured by hospitalization data extracted from the EHR
Change in medication adherence as measured by number of prescriptions filled extracted from the EHR

Full Information

First Posted
October 2, 2018
Last Updated
June 18, 2020
Sponsor
Medstar Health Research Institute
Collaborators
National Institutes of Health (NIH), Georgetown-Howard Universities Center for Clinical and Translational Science, ObEN Artificial Intelligence
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1. Study Identification

Unique Protocol Identification Number
NCT03707275
Brief Title
Personalized Voice Activated Wellness Assistants for Patients With Heart Failure
Official Title
Personalized Voice Activated Wellness Assistants for Patients With Heart Failure
Study Type
Interventional

2. Study Status

Record Verification Date
June 2020
Overall Recruitment Status
Completed
Study Start Date
December 10, 2018 (Actual)
Primary Completion Date
October 31, 2019 (Actual)
Study Completion Date
October 31, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Medstar Health Research Institute
Collaborators
National Institutes of Health (NIH), Georgetown-Howard Universities Center for Clinical and Translational Science, ObEN Artificial Intelligence

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure, Congestive Heart Failure
Keywords
Clinical trial, Patient-centered outcomes, Treatment of heart failure, Technology in heart failure

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
50 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Alexa+ Arm
Arm Type
Experimental
Arm Title
Standard of Care Arm
Arm Type
Other
Intervention Type
Device
Intervention Name(s)
Alexa+
Intervention Description
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
Other
Intervention Name(s)
Standard of Care Arm
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in comfort level using Alexa+ technology as measured by the pre and post-test technology comfort survey
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Change in number of hospitalizations as measured by hospitalization data extracted from the EHR
Time Frame
3 months
Title
Change in medication adherence as measured by number of prescriptions filled extracted from the EHR
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nawar M Shara, M.S., PhD
Organizational Affiliation
Medstar Health Research Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
MedStar Washington Hospital Center
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20010
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing 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.

Learn more about this trial

Personalized Voice Activated Wellness Assistants for Patients With Heart Failure

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