Care.Coach Avatars for Improvement of Outcomes in Hospitalized Elders, Including Mitigation of Falls and Delirium: a Multi-Site Clinical Study

NCT ID: NCT03832192

Last Updated: 2023-08-14

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

301 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-01-08

Study Completion Date

2021-01-07

Brief Summary

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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.

Detailed Description

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Conditions

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Delirium Fall Injury

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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care.coach Avatar

Group Type EXPERIMENTAL

care.coach Avatar (HELP-Protocolized)

Intervention Type BEHAVIORAL

care.coach human-in-the-loop avatar system with software-directed protocols based on the Hospital Elder Life Program (HELP).

Control

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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).

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* fall/delirium risk (may be based purely on age at the election of each site, e.g. 65+)

Exclusion Criteria

* 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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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National Institute of Nursing Research (NINR)

NIH

Sponsor Role collaborator

Pace University

OTHER

Sponsor Role collaborator

Victor Wang

INDUSTRY

Sponsor Role lead

Responsible Party

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Victor Wang

Principal Investigator

Responsibility Role SPONSOR_INVESTIGATOR

Locations

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Jamaica Hospital Medical Center

New York, New York, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

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Related Links

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http://care.coach

care.coach human-in-the-loop avatars for psychosocial support, health coaching, and care coordination

Other Identifiers

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1R44NR017842-02

Identifier Type: NIH

Identifier Source: org_study_id

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