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Personalized Voice Activated Wellness Assistants for Patients With Heart Failure

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03707275
Recruitment Status : Completed
First Posted : October 16, 2018
Last Update Posted : June 19, 2020
Sponsor:
Collaborators:
National Institutes of Health (NIH)
Georgetown-Howard Universities Center for Clinical and Translational Science
ObEN Artificial Intelligence
Information provided by (Responsible Party):
Nawar Shara, Medstar Health Research Institute

Study Description
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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.

Condition or disease Intervention/treatment Phase
Heart Failure Congestive Heart Failure Device: Alexa+ Other: Standard of Care Arm Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Personalized Voice Activated Wellness Assistants for Patients With Heart Failure
Actual Study Start Date : December 10, 2018
Actual Primary Completion Date : October 31, 2019
Actual Study Completion Date : October 31, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Failure

Arms and Interventions
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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.
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.


Outcome Measures
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Primary Outcome Measures :
  1. Change in comfort level using Alexa+ technology as measured by the pre and post-test technology comfort survey [ Time Frame: 3 months ]

Secondary Outcome Measures :
  1. Change in number of hospitalizations as measured by hospitalization data extracted from the EHR [ Time Frame: 3 months ]
  2. Change in medication adherence as measured by number of prescriptions filled extracted from the EHR [ Time Frame: 3 months ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03707275


Locations
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United States, District of Columbia
MedStar Washington Hospital Center
Washington, District of Columbia, United States, 20010
Sponsors and Collaborators
Medstar Health Research Institute
National Institutes of Health (NIH)
Georgetown-Howard Universities Center for Clinical and Translational Science
ObEN Artificial Intelligence
Investigators
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Principal Investigator: Nawar M Shara, M.S., PhD Medstar Health Research Institute
More Information
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Responsible Party: Nawar Shara, Director, Department of Biostatistics and Biomedical Informatics, Medstar Health Research Institute
ClinicalTrials.gov Identifier: NCT03707275    
Other Study ID Numbers: Alexa+ Study
UL1TR001409 ( U.S. NIH Grant/Contract )
First Posted: October 16, 2018    Key Record Dates
Last Update Posted: June 19, 2020
Last Verified: June 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
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.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Nawar Shara, Medstar Health Research Institute:
Clinical trial
Patient-centered outcomes
Treatment of heart failure
Technology in heart failure
Additional relevant MeSH terms:
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Heart Failure
Heart Diseases
Cardiovascular Diseases