Heart FailureNCT03707275
Personalized Voice Activated Wellness Assistants for Patients With Heart Failure
A study testing Alexa+ in people with Heart Failure and Congestive Heart Failure, run by Medstar Health Research Institute at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure, Congestive Heart Failure
- What is being tested?
- Alexa+
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Dec 2018to 31 Oct 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Participation in another interventional clinical trial
Trial locations and contacts
1 site in 1 country.
United States1 site
MedStar Washington Hospital Center
Washington D.C., District of Columbia, 20010
About this study
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.
Read the 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.
- Conditions
- Heart Failure, Congestive Heart Failure
- Being tested
- Alexa+, Standard of Care Arm
- Keywords
- Clinical trial, Patient-centered outcomes, Treatment of heart failure, Technology in heart failure
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
Standard of Care ArmOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Alexa+ Arm | Experimental | Not described Receives: Device: Alexa+ |
| Standard of Care Arm | Other | Not described Receives: Other: Standard of Care Arm |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in comfort level using Alexa+ technology as measured by the pre and post-test technology comfort survey
Measured: 3 months
Secondary outcomes (2)
Change in number of hospitalizations as measured by hospitalization data extracted from the EHR
Measured: 3 months
Change in medication adherence as measured by number of prescriptions filled extracted from the EHR
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Oct 2018
- Study start10 Dec 2018
- Primary completion31 Oct 2019
- Study completion31 Oct 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medstar Health Research Institute
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH), Georgetown-Howard Universities Center for Clinical and Translational Science, ObEN Artificial Intelligence
- Responsible party
- Principal investigator, Nawar Shara, Medstar Health Research Institute
- Investigators
- Nawar M Shara, M.S., PhD, Principal investigator, Medstar Health Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03707275
- Sponsor's protocol ID
- Alexa+ Study
- Other IDs
- UL1TR001409
- Status last verified
- Jun 2020
- First submitted
- 2 Oct 2018
- Last updated
- 19 Jun 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Study at a glance
From the registry record, last updated by the sponsor on 19 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Personalized Voice Activated Wellness Assistants for Patients With Heart Failure
- ClinicalTrials.gov ID
- NCT03707275
- Acronym / sponsor ID
- Alexa+ Study
- Conditions
- Heart Failure, Congestive Heart Failure
- Keywords
- Clinical trial, Patient-centered outcomes, Treatment of heart failure, Technology in heart failure
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Medstar Health Research InstituteUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH), Georgetown-Howard Universities Center for Clinical and Translational Science, ObEN Artificial Intelligence
- Study start
- 10 Dec 2018 (actual)
- Primary completion
- 31 Oct 2019 (actual)
- Study completion
- 31 Oct 2019 (actual)
- First posted
- 16 Oct 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Alexa+ Arm | Experimental | Device: Alexa+ |
| Standard of Care Arm | Other | Other: Standard of Care Arm |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (1 listed)
- Participation in another interventional clinical trial
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Device | Alexa+ Arm |
| Standard of Care ArmThis 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. | Other | Standard of Care Arm |
Primary outcome
Change in comfort level using Alexa+ technology as measured by the pre and post-test technology comfort survey
Time frame: 3 months
2 secondary outcomes
Change in number of hospitalizations as measured by hospitalization data extracted from the EHR
Time frame: 3 months
Change in medication adherence as measured by number of prescriptions filled extracted from the EHR
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jun 2020.
- Individual participant dataSharing planned: No. 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nawar M Shara, M.S., PhD principal investigator
Medstar Health Research Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Alexa+ in people with Heart Failure and Congestive Heart Failure, run by Medstar Health Research Institute at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in comfort level using Alexa+ technology as measured by the pre and post-test technology comfort survey (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Jun 2020.