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