DeliriumPhase 2AvatarHELPNCT03832192
Care.Coach Avatars for Improvement of Outcomes in Hospitalized Elders, Including Mitigation of Falls and Delirium: a Multi-Site Clinical Study
A Phase 2 study testing care.coach Avatar (HELP-Protocolized) in people with Delirium and Fall Injury, run by Victor Wang at 1 site in United States.
Trial summary
Through NINR project 1R44NR017842-01 which preceded the present study, the investigators enhanced the care.coach avatar platform to incorporate a robust suite of evidence-based protocols based on the Hospital Elder Life Program (HELP), and to leverage an integration with hospital-based electronic medical record (EMR)… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Delirium, Fall Injury
- What is being tested?
- care.coach Avatar (HELP-Protocolized)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 301 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Jan 2019to 7 Jan 2021
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- fall/delirium risk (may be based purely on age at the election of each site, e.g. 65+)
Who cannot join
- aggression or combativeness with intent to harm self or others
- severe hearing impairment and simultaneous severe vision impairment, despite assistive devices
- no comprehension of either Spanish or English
Trial locations and contacts
1 site in 1 country.
United States1 site
Jamaica Hospital Medical Center
New York, New York, 11418
About this study
Official title: Care.Coach Avatars for Improvement of Outcomes in Hospitalized Elders, Including Mitigation of Falls and Delirium, Through Psychosocial Support and Protocol-Driven Interventions Based on the Hospital Elder Life Program: a Multi-Site Clinical Study
Through NINR project 1R44NR017842-01 which preceded the present study, the investigators enhanced the care.coach avatar platform to incorporate a robust suite of evidence-based protocols based on the Hospital Elder Life Program (HELP), and to leverage an integration with hospital-based electronic medical record (EMR) systems. In the present study, the investigators seek to validate the efficacy of the new avatar platform, as measured by reduction in falls, delirium, and patient sitter utilization. Also, the investigators seek to gather patient and outcomes data at a scale sufficient to begin developing machine learning algorithms for intelligent, automatic assignment of protocols to maximize patient engagement and clinical efficacy, and for intelligent, automatic screening of delirium to assist care teams in positive identification of delirium. Therefore, the present study comprises a two-year randomized between-groups comparison across multiple hospitals to compare outcomes with the new generation of care.coach avatars as the intervention versus usual care only as the control. Each study group will be geographically distributed across participating research sites: initially MediSys Health Network's Jamaica Hospital Medical Center in New York, with additional hospitals to join the study over the course of two years.
- Conditions
- Delirium, Fall Injury
- Being tested
- care.coach Avatar (HELP-Protocolized)
- Keywords
- patient satisfaction, HCAHPS, loneliness, delirium, falls, HELP, hospitals, geriatrics, elder care
- Medical subject headings
- Delirium, Patient Satisfaction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
care.coach Avatar (HELP-Protocolized)Behavioural
care.coach human-in-the-loop avatar system with software-directed protocols based on the Hospital Elder Life Program (HELP).
| Study group | Role | What they receive |
|---|---|---|
| care.coach Avatar | Experimental | Not described Receives: Behavioral: care.coach Avatar (HELP-Protocolized) |
| Control | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incident Delirium Rate
For each patient without prevalent delirium (each patient who screens negative per the Confusion Assessment Method [CAM] upon study enrollment, which is assumed to be within 24 hours of admission to the hospital unit), Incident Delirium is indicated by any positive CAM screen during the patient's study enrollment period, with CAM screens being performed at least daily (the final CAM screen is assumed to be within 24 hours of discharge from the hospital unit). Incident Delirium is thus a binary variable (true/false) for each patient, and the rate of Incident Delirium will be compared across study groups, with a lower rate being desirable.
Measured: From beginning to end of each participant's inpatient stay, an average of 4 days
Secondary outcomes (2)
Delirium Resolution Rate
For each patient with prevalent delirium (each patient who screens positive per the Confusion Assessment Method [CAM] upon study enrollment, which is assumed to be within 24 hours of admission to the hospital unit), delirium will be considered resolved if the patient's final CAM screen (which is assumed to be within 24 hours prior to discharge from the hospital unit) indicates no delirium. Delirium Resolution is thus a binary variable (true/false) for each patient, and the rate of successful Delirium Resolution will be compared across study groups, with a higher rate being desirable.
Measured: From beginning to end of each participant's inpatient stay, an average of 4 days
Change in Cognitive Function
For each patient, the Short Portable Mental Status Questionnaire (SPMSQ) is administered to measure cognitive function (0-10 errors, more errors indicating greater cognitive impairment) upon enrollment and upon dis-enrollment from the study. Change in Cognitive Function is the difference from the enrollment SPMSQ score to the dis-enrollment SPMSQ score. Change in Cognitive Function will be compared across study groups, with a larger numerical reduction being desirable.
Measured: From beginning to end of each participant's inpatient stay, an average of 4 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2019
- Study start8 Jan 2019
- Primary completion7 Jan 2021
- Study completion7 Jan 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for DeliriumStudies 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 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 301 participants (actual)
Sponsor and investigators
- Lead sponsor
- Victor Wang
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- National Institute of Nursing Research (NINR), Pace University
- Responsible party
- Sponsor-investigator, Victor Wang, care.coach corporation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03832192
- Sponsor's protocol ID
- 1R44NR017842-02
- Acronym
- AvatarHELP
- Status last verified
- Jul 2023
- First submitted
- 29 Jan 2019
- Last updated
- 14 Aug 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Care.Coach Avatars for Improvement of Outcomes in Hospitalized Elders, Including Mitigation of Falls and Delirium, Through Psychosocial Support and Protocol-Driven Interventions Based on the Hospital Elder Life Program: a Multi-Site Clinical Study
- ClinicalTrials.gov ID
- NCT03832192
- Acronym / sponsor ID
- AvatarHELP / 1R44NR017842-02
- Conditions
- Delirium, Fall Injury
- Keywords
- patient satisfaction, HCAHPS, loneliness, delirium, falls, HELP, hospitals, geriatrics
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 301 participants (actual)
- Lead sponsor
- Victor WangIndustry (pharma, biotech, devices)
- Collaborators
- National Institute of Nursing Research (NINR), Pace University
- Study start
- 8 Jan 2019 (actual)
- Primary completion
- 7 Jan 2021 (actual)
- Study completion
- 7 Jan 2021 (actual)
- First posted
- 6 Feb 2019 (actual)
- Results
- Posted 14 Aug 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Through NINR project 1R44NR017842-01 which preceded the present study, the investigators enhanced the care.coach avatar platform to incorporate a robust suite of evidence-based protocols based on the Hospital Elder Life Program (HELP), and to leverage an integration with hospital-based electronic medical record (EMR) systems. In the present study, the investigators seek to validate the efficacy of the new avatar platform, as measured by reduction in falls, delirium, and patient sitter utilization. Also, the investigators seek to gather patient and outcomes data at a scale sufficient to begin developing machine learning algorithms for intelligent, automatic assignment of protocols to maximize patient engagement and clinical efficacy, and for intelligent, automatic screening of delirium to assist care teams in positive identification of delirium. Therefore, the present study comprises a two-year randomized between-groups comparison across multiple hospitals to compare outcomes with the new generation of care.coach avatars as the intervention versus usual care only as the control. Each study group will be geographically distributed across participating research sites: initially MediSys Health Network's Jamaica Hospital Medical Center in New York, with additional hospitals to join the study over the course of two years.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| care.coach Avatar | Experimental | Behavioral: care.coach Avatar (HELP-Protocolized) |
| Control | No intervention | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- fall/delirium risk (may be based purely on age at the election of each site, e.g. 65+)
Key exclusion criteria (3 listed)
- aggression or combativeness with intent to harm self or others
- severe hearing impairment and simultaneous severe vision impairment, despite assistive devices
- no comprehension of either Spanish or English
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 |
|---|---|---|
| care.coach Avatar (HELP-Protocolized)care.coach human-in-the-loop avatar system with software-directed protocols based on the Hospital Elder Life Program (HELP). | Behavioural | care.coach Avatar |
Primary outcome
Incident Delirium Rate
Time frame: From beginning to end of each participant's inpatient stay, an average of 4 days
For each patient without prevalent delirium (each patient who screens negative per the Confusion Assessment Method [CAM] upon study enrollment, which is assumed to be within 24 hours of admission to the hospital unit), Incident Delirium is indicated by any positive CAM screen during the patient's study enrollment period, with CAM screens being performed at least daily (the final CAM screen is assumed to be within 24 hours of discharge from the hospital unit). Incident Delirium is thus a binary variable (true/false) for each patient, and the rate of Incident Delirium will be compared across study groups, with a lower rate being desirable.
2 secondary outcomes
Delirium Resolution Rate
Time frame: From beginning to end of each participant's inpatient stay, an average of 4 days
Change in Cognitive Function
Time frame: From beginning to end of each participant's inpatient stay, an average of 4 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- care.coach human-in-the-loop avatars for psychosocial support, health coaching, and care coordinationLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing care.coach Avatar (HELP-Protocolized) in people with Delirium and Fall Injury, run by Victor Wang 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 1 inclusion and 3 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 14 Aug 2023. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 14 Aug 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Incident Delirium Rate (time frame: From beginning to end of each participant's inpatient stay, an average of 4 days). 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 14 Aug 2023.