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Clinical Trial 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.


Clinical Trial 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. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT03621228
Study type Interventional
Source Simon Fraser University
Contact Gloria Gutman, PhD
Phone 778.782.5063
Email gutman@sfu.ca
Status Not yet recruiting
Phase N/A
Start date September 2018
Completion date April 2019

See also
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Recruiting NCT04824144 - Effects of Dexmedetomidine in Patients With Agitated Delirium in Palliative Care Phase 1/Phase 2
Recruiting NCT04833023 - HALO Trial: Haloperidol vs Olanzapine in Hyperactive Delirium in Palliative Care Patients; A Multi-Centre, Randomised-Controlled Trial Phase 3
Withdrawn NCT04513314 - Valproate Alone or in Combination With Quetiapine for Severe COVID-19 Pneumonia With Agitated Delirium Phase 4
Terminated NCT02343575 - Valproic Acid for Treatment of Hyperactive or Mixed Delirium in ICU Phase 4
Completed NCT03954769 - A Pilot Study of "Stanford Proxy Test for Delirium" (S-PTD)
Completed NCT05690698 - Quetiapine Versus Haloperidol in the Management of Hyperactive Delirium Phase 3