Personalized Voice Activated Wellness Assistants for Patients With Heart Failure

Study Overview
=================
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.

Official Title
-----------------
Personalized Voice Activated Wellness Assistants for Patients With Heart Failure

Conditions
-----------------
Heart Failure, Congestive Heart Failure

Intervention / Treatment
-----------------
* Device: Alexa+
* Other: Standard of Care Arm


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Alexa+ Arm<br> | Device: Alexa+<br>* 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.<br>|
| Other: Standard of Care Arm<br> | Other: Standard of Care Arm<br>* 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.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in comfort level using Alexa+ technology as measured by the pre and post-test technology comfort survey |  | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Clinical trial, Patient-centered outcomes, Treatment of heart failure, Technology in heart failure