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Use of a Novel Digital Therapeutic Intervention for the Management of Delirium in the Acute Care Environment

NCT04652622 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 70

Last updated 2023-01-06

No results posted yet for this study

Summary

Delirium is a condition of fluctuating confusion and agitation that affects as many as 80% of patients in critical care. Hyperactive delirium consumes a significant amount of clinical attention and resources due to the associated psychomotor agitation. Patients can become aggressive or combative putting both themselves and healthcare workers at risk of harm. Delirium has been linked to an increased risk of death and poor overall outcomes. Management largely relies on the use of potentially toxic medications and physical restraints despite limited proof of success of these interventions. Our research group will study the use of a novel interactive digital therapeutic behavior modification platform aimed at reducing anxiety and agitation associated with hyperactive delirium. We hypothesize that Use of the Mindful Garden behavioral modification platform will result in normalization of agitation and delirium scores when used for the management of delirium associated agitation in the adult delirious acute care population compared to standard care alone.

Conditions

  • Delirium

Interventions

DEVICE

Mindful Garden

Mindful Garden is an interactive digital behavior modification platform utilizing inbuilt sensors and screen based delivery system. The platform delivers calming visual output of real nature video layered with hyper-real animations of growing and receding flowers and butterflies in flight in a volume directly responsive to measured patient activity. Patient movement and vocalization are the surrogate markers for agitation and using proprietary algorithms drive onscreen content.

Sponsors & Collaborators

  • BC Support Unit

    collaborator OTHER

  • Royal Columbian Hospital Foundation

    collaborator OTHER

  • Mitacs

    collaborator INDUSTRY

  • Fraser Health

    lead OTHER

Principal Investigators

  • Steven Reynolds · Fraser Health Authority

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-03-16
Primary Completion
2022-01-05
Completion
2022-12-05

Countries

  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04652622 on ClinicalTrials.gov