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MindfulGarden in Treatment of Hyperactive Delirium in a Hospital Setting

Primary Purpose

Hyperactive Delirium

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
MindfulGarden
Sponsored by
Simon Fraser University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Hyperactive Delirium focused on measuring Delirium, Hyperactive, Aggression, Anxiety, Digital therapy

Eligibility Criteria

65 Years - undefined (Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

- All patients aged 65 years or older admitted to the Emergency Department who have a diagnosis of hyperactive delirium as defined by the short CAM

Exclusion Criteria:

  • Patients with severe vision impairment or who are legally blind
  • Patients for whom a bed in a medical ward was not available within 12 hours of a diagnosis of hyperactive delirium (i.e. who remained in the Emergency Department more than 12 hours)

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    No Intervention

    Arm Label

    MindfulGarden

    Control

    Arm Description

    Standard care + exposure to an interactive digital device

    Standard care only

    Outcomes

    Primary Outcome Measures

    Recruitment Rates
    Number of participants approached and their rate of consent

    Secondary Outcome Measures

    Estimate the potential effect size
    MG association with reducing delirium duration as measured CAM - short
    Adverse Outcomes (number of patients with aggressive/violent behaviours, falls, code white)
    Assess from patients medical chart
    Psychotropic Drug Consumption
    Assess from patient's medical chart
    Application of Physical Restraints
    Assess from patient's medical chart
    Length of Stay
    Assess from patient's medical chart

    Full Information

    First Posted
    July 27, 2018
    Last Updated
    August 9, 2018
    Sponsor
    Simon Fraser University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03621228
    Brief Title
    MindfulGarden in Treatment of Hyperactive Delirium in a Hospital Setting
    Official Title
    A Pilot Study of an Interactive Digital Technology (MindfulGarden) in Treatment of Hyperactive Delirium in a Hospital Setting
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2018
    Overall Recruitment Status
    Unknown status
    Study Start Date
    September 2018 (Anticipated)
    Primary Completion Date
    March 2019 (Anticipated)
    Study Completion Date
    April 2019 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Simon Fraser University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    This pilot study is designed to address feasibility for a larger randomized control clinical study that will determine the efficacy of exposure to the MindfulGarden - an interactive digital technology - in reducing hyperactive delirium in hospitalized older adults.
    Detailed Description
    The primary objective of the study is to establish whether the key components necessary for conducting a full randomized control study in the future, such as recruitment, consent, randomization, and treatment processes are working well and all function together. As a secondary objective, the investigators will determine trends in patients exposed to MindfulGarden (MG), for example: At the first and second administration of the Confusion Assessment Method - short form (CAM) after admission to a medical ward are there more, the same or fewer patients in the intervention group than in the control group whose CAM scores change from positive to negative? During the first 24 hours after admission to a medical ward, did fewer, the same, or a greater number of patients in the intervention than in the control group experience significant events/alerts (e.g. aggressive/violent behaviours, falls, code white)? During the first 24 hours after admission to a medical ward, were fewer, the same, or a greater number of patients in the intervention than in the control group administered psychotropic drugs (e.g. haloperidol, risperidone, quetiapine, lorazepam)? were more, the same, or fewer administered sleeping aids (e.g. trazodone, melatonin)? During the first 24 hours after admission to a medical ward, were fewer, the same, or a greater number of patients in the intervention than in the control group physically restrained? Was mean length of stay from time of admission to a medical ward until discharge due to death, return to place of residence before admission or to a different place of residence longer, the same or shorter in the intervention than in the control group? Were there more, the same or fewer deaths or discharges to a higher level of care (e.g. to assisted living, to a complex care facility in patients who previously lived at home) in the intervention than the control group? Additionally, to the extent that movement and vocalization are reflective of anxiety, agitation and/or aggression (i.e. responsive behaviours) the investigators also want to determine whether there is a correlation between changes in these as recorded by the MG and any of the indicators listed in 1-6 above.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Hyperactive Delirium
    Keywords
    Delirium, Hyperactive, Aggression, Anxiety, Digital therapy

    7. Study Design

    Primary Purpose
    Supportive Care
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Outcomes Assessor
    Allocation
    Randomized
    Enrollment
    24 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    MindfulGarden
    Arm Type
    Experimental
    Arm Description
    Standard care + exposure to an interactive digital device
    Arm Title
    Control
    Arm Type
    No Intervention
    Arm Description
    Standard care only
    Intervention Type
    Device
    Intervention Name(s)
    MindfulGarden
    Intervention Description
    MindfulGarden (MG) is an interactive digital technology that combines use of a smart television with sensors to intelligently generate content based on patient voice and gesture input, triggering a multi-layered visual 'garden' on-screen to arrest and de-escalate anxiety and aggression in treatment of hospitalized elderly diagnosed with hyperactive delirium.
    Primary Outcome Measure Information:
    Title
    Recruitment Rates
    Description
    Number of participants approached and their rate of consent
    Time Frame
    Number enrolled within 12 hours of admission to Emergency Department
    Secondary Outcome Measure Information:
    Title
    Estimate the potential effect size
    Description
    MG association with reducing delirium duration as measured CAM - short
    Time Frame
    24-hour period following transfer from Emergency Department
    Title
    Adverse Outcomes (number of patients with aggressive/violent behaviours, falls, code white)
    Description
    Assess from patients medical chart
    Time Frame
    24-hour period following transfer from Emergency Department
    Title
    Psychotropic Drug Consumption
    Description
    Assess from patient's medical chart
    Time Frame
    24-hour period following transfer from Emergency Department
    Title
    Application of Physical Restraints
    Description
    Assess from patient's medical chart
    Time Frame
    24-hour period following transfer from Emergency Department
    Title
    Length of Stay
    Description
    Assess from patient's medical chart
    Time Frame
    Date of study enrolment through to discharge from hospital, or date of study enrolment up to 30 days

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    65 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: - All patients aged 65 years or older admitted to the Emergency Department who have a diagnosis of hyperactive delirium as defined by the short CAM Exclusion Criteria: Patients with severe vision impairment or who are legally blind Patients for whom a bed in a medical ward was not available within 12 hours of a diagnosis of hyperactive delirium (i.e. who remained in the Emergency Department more than 12 hours)
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Gloria Gutman, PhD
    Phone
    778.782.5063
    Email
    gutman@sfu.ca
    First Name & Middle Initial & Last Name or Official Title & Degree
    Fabio Feldman, PhD
    Phone
    6045877850
    Email
    fabio.feldman@fraserhealth.ca
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Gloria Gutman
    Organizational Affiliation
    Simon Fraser University
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    MindfulGarden in Treatment of Hyperactive Delirium in a Hospital Setting

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