MindfulGarden in Treatment of Hyperactive Delirium in a Hospital Setting

Study Overview
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Brief Summary
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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
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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.

Official Title
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A Pilot Study of an Interactive Digital Technology (MindfulGarden) in Treatment of Hyperactive Delirium in a Hospital Setting

Conditions
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Hyperactive Delirium

Intervention / Treatment
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* Device: MindfulGarden


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: MindfulGarden<br>Standard care + exposure to an interactive digital device | Device: MindfulGarden<br>* 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.<br>|
| No Intervention: Control<br>Standard care only | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Recruitment Rates | Number of participants approached and their rate of consent | Number enrolled within 12 hours of admission to Emergency Department | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Estimate the potential effect size | MG association with reducing delirium duration as measured CAM - short | 24-hour period following transfer from Emergency Department | 
| Adverse Outcomes (number of patients with aggressive/violent behaviours, falls, code white) | Assess from patients medical chart | 24-hour period following transfer from Emergency Department | 
| Psychotropic Drug Consumption | Assess from patient's medical chart | 24-hour period following transfer from Emergency Department | 
| Application of Physical Restraints | Assess from patient's medical chart | 24-hour period following transfer from Emergency Department | 
| Length of Stay | Assess from patient's medical chart | Date of study enrolment through to discharge from hospital, or date of study enrolment up to 30 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Delirium, Hyperactive, Aggression, Anxiety, Digital therapy