Clinical trial NCT03621228: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Hyperactive Delirium
Keywords: Delirium
Hyperactive
Aggression
Anxiety
Digital therapy
Lead sponsor: Simon Fraser University
Sponsor class: OTHER
First posted: 2018-08-08
Enrollment: 24
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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)

Primary outcomes:
measure: Recruitment Rates
timeFrame: Number enrolled within 12 hours of admission to Emergency Department
Secondary outcomes:
measure: Estimate the potential effect size
timeFrame: 24-hour period following transfer from Emergency Department
measure: Adverse Outcomes (number of patients with aggressive/violent behaviours, falls, code white)
timeFrame: 24-hour period following transfer from Emergency Department
measure: Psychotropic Drug Consumption
timeFrame: 24-hour period following transfer from Emergency Department
measure: Application of Physical Restraints
timeFrame: 24-hour period following transfer from Emergency Department
measure: Length of Stay
timeFrame: Date of study enrolment through to discharge from hospital, or date of study enrolment up to 30 days
Other outcomes:
Locations:
Study officials:
affiliation: Simon Fraser University
name: Gloria Gutman
role: PRINCIPAL_INVESTIGATOR
References: