Hyperactive Delirium
Conditions
Keywords
Delirium, Hyperactive, Aggression, Anxiety, Digital therapy
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: 1. 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? 2. 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)? 3. 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)? 4. 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? 5. 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? 6. 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.
Interventions
DEVICEMindfulGarden
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.
Sponsors
Simon Fraser University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Recruitment Rates | Number enrolled within 12 hours of admission to Emergency Department | Number of participants approached and their rate of consent |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Estimate the potential effect size | 24-hour period following transfer from Emergency Department | MG association with reducing delirium duration as measured CAM - short |
| Adverse Outcomes (number of patients with aggressive/violent behaviours, falls, code white) | 24-hour period following transfer from Emergency Department | Assess from patients medical chart |
| Psychotropic Drug Consumption | 24-hour period following transfer from Emergency Department | Assess from patient's medical chart |
| Application of Physical Restraints | 24-hour period following transfer from Emergency Department | Assess from patient's medical chart |
| Length of Stay | Date of study enrolment through to discharge from hospital, or date of study enrolment up to 30 days | Assess from patient's medical chart |
Contacts
Primary ContactGloria Gutman, PhD
Backup ContactFabio Feldman, PhD
Outcome results
None listed