MindfulGarden in Treatment of Hyperactive Delirium in a Hospital Setting

NCT03621228 | Unknown

• 1 other identifier: MindfulGarden-H-Pilot
• Study Type: interventional
• Target: 24
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Hyperactive Delirium

Keywords

Delirium; Hyperactive; Aggression; Anxiety; Digital therapy

Outcome Measures

Primary Outcomes (1)

• Recruitment Rates

  Number of participants approached and their rate of consent

  Number enrolled within 12 hours of admission to Emergency Department

Secondary Outcomes (5)

• Estimate the potential effect size

  24-hour period following transfer from Emergency Department

• Adverse Outcomes (number of patients with aggressive/violent behaviours, falls, code white)

  24-hour period following transfer from Emergency Department

• Psychotropic Drug Consumption

  24-hour period following transfer from Emergency Department

• Application of Physical Restraints

  24-hour period following transfer from Emergency Department

• Length of Stay

  Date of study enrolment through to discharge from hospital, or date of study enrolment up to 30 days

Study Arms (2)

MindfulGarden

EXPERIMENTAL

Standard care + exposure to an interactive digital device

Device: MindfulGarden

Control

NO INTERVENTION

Standard care only

Interventions

MindfulGarden DEVICE

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.

MindfulGarden

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• \- 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Simon Fraser University: lead

MeSH Terms

Conditions

Delirium; Spasm; Aggression; Anxiety Disorders

Condition Hierarchy (Ancestors)

Confusion; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurocognitive Disorders; Mental Disorders; Neuromuscular Manifestations; Aberrant Motor Behavior in Dementia; Behavioral Symptoms; Behavior; Social Behavior

Study Officials

• Gloria Gutman

  Simon Fraser University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Gloria Gutman, PhD

CONTACT

778.782.5063; gutman@sfu.ca

Fabio Feldman, PhD

CONTACT

6045877850; fabio.feldman@fraserhealth.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor Emerita

Study Record Dates

• First Submitted: July 27, 2018
• First Posted: August 8, 2018
• Study Start: September 1, 2018
• Primary Completion: March 1, 2019
• Study Completion: April 1, 2019
• Last Updated: August 13, 2018

Record last verified: 2018-08

Data Sharing

• IPD Sharing: Will not share