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

NCT04652622 | Completed

• 1 other identifier: FHREB 2020-091
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

digital therapeutic; behavioral; critical care; behavior modification

Outcome Measures

Primary Outcomes (1)

• Agitation scores

  Richmond Agitation Sedation Score is a validated and standardized scoring system ranging from -5 (deeply sedated) to 0 (awake and calm) to +4 (combative). Scores are measured hourly from study start, one hour post intervention and at the start of the following nursing shift.

  5 hours

Secondary Outcomes (9)

• Use of unscheduled medications for the management of delirium associated agitation

  4 hours

• Delirium Scores

  4 hours

• Richmond Agitation Sedation Scale of zero

  4 hours

• Physical Restraint Use

  4 hours

• Incidence of Unplanned Line removal

  4 hours

Other Outcomes (2)

• Survey of caregivers

  4 hours

• Survey of family members

  4 hours

Study Arms (2)

Intervention arm

EXPERIMENTAL

Participants will receive 4 hours of exposure to the Mindful Garden digital therapeutic platform in addition to standard care

Device: Mindful Garden

Control Arm

NO INTERVENTION

Participants will be monitored over a 4 hour period of standard care interventions

Interventions

Mindful Garden DEVICE

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.

Intervention arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult (age \>18yrs)
• Admitted to the Royal Columbian Hospital
• RASS +1 or greater for 2 assessments 1 hour apart within the 24-hour period directly prior to study enrollment and persisting at the time of enrollment
• Demonstrated incidence of at least 2 PRN medication events for the management of delirium-associated agitation in the preceding 24 hours and/or infusion of psycho- active medication for the management of delirium (eg: dexmeditomodine)
• ICDSC greater than or equal to 4 at time of enrollment or CAM positive

You may not qualify if:

• Planned procedure or test that precludes participation in the full 4-hour study session
• Unable to see (visual impairment such as documented blindness, ongoing inability to keep eyes open or documented or assessed inability to focus, track or maintain visual contact for extended periods as determined by recruitment personnel)
• Significant uncontrolled pain with a Verbal Pain scale of 5/10 or greater or a Clinical Pain Observation Tool \>4 despite intervention at the time of enrollment.
• RASS of 0 to -5 at study enrollment indicating patient is awake and calm or sedated
• Refusal for participation by the participant's responsible physician or request to not retain data by participants substitute decision maker
• Currently enrolled in any other research study involving drugs or devices which could impact on the outcomes of interest, as evaluated by the Principal Investigator

Sponsors & Collaborators

• Fraser Health: lead
• BC Support Unit: collaborator
• Royal Columbian Hospital Foundation: collaborator
• Mitacs: collaborator

Study Sites (1)

Royal Columbian Hospital

New Westminster, British Columbia, V3L 3W7, Canada

Location

MeSH Terms

Conditions

Delirium; Behavior

Condition Hierarchy (Ancestors)

Confusion; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurocognitive Disorders; Mental Disorders

Study Officials

• Steven Reynolds

  Fraser Health Authority

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: data will be blinded for analysis but the study is open label due to the nature of the intervention
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: participants will be randomized to either exposure to the intervention arm in conjunction with standard care or the control arm and will receive standard care alone

Study Record Dates

• First Submitted: November 17, 2020
• First Posted: December 3, 2020
• Study Start: March 16, 2021
• Primary Completion: January 5, 2022
• Study Completion: December 5, 2022
• Last Updated: January 6, 2023

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)