MindfulGarden in Treatment of Hyperactive Delirium in a Hospital Setting

Hyperactive Delirium Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03621228
• Other study ID #: MindfulGarden-H-Pilot
• Status: Not yet recruiting
• Phase: N/A
• Start date: September 2018
• Est. completion date: April 2019

Study information

• Verified date: August 2018
• Source: Simon Fraser University
• Contact: Gloria Gutman, PhD
• Phone: 778.782.5063
• Email: gutman[@]sfu.ca
• Is FDA regulated: No
• Study type: Interventional

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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 24
• Est. completion date: April 2019
• Est. primary completion date: March 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Delirium
• Hyperactive Delirium
• Hyperkinesis

Intervention

Device:
• MindfulGarden
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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Simon Fraser University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Recruitment Rates	Number of participants approached and their rate of consent	Number enrolled within 12 hours of admission to Emergency Department
Secondary	Estimate the potential effect size	MG association with reducing delirium duration as measured CAM - short	24-hour period following transfer from Emergency Department
Secondary	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
Secondary	Psychotropic Drug Consumption	Assess from patient's medical chart	24-hour period following transfer from Emergency Department
Secondary	Application of Physical Restraints	Assess from patient's medical chart	24-hour period following transfer from Emergency Department
Secondary	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