Back to resultsUse of a Novel Digital Therapeutic Intervention for the Management of Delirium in the Acute Care Environment
Primary Purpose
Delirium
Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Mindful Garden
Sponsored by
About this trial
This is an interventional treatment trial for Delirium focused on measuring digital therapeutic, behavioral, critical care, behavior modification
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Sites / Locations
- Royal Columbian Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Intervention arm
Control Arm
Arm Description
Participants will receive 4 hours of exposure to the Mindful Garden digital therapeutic platform in addition to standard care
Participants will be monitored over a 4 hour period of standard care interventions
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Use of unscheduled medications for the management of delirium associated agitation
Incidence of unscheduled or "PRN" medication use for the management of delirium associated agitation throughout the 4 hour study period
Delirium Scores
Delirium scores will be measured using the Intensive Care Delirium Screening Checklist. Delirium score is a range of zero to 8 with scores above or equal to 4 being diagnostic for the presence of delirium and higher scores being indicative of added severity of symptoms. Intensive Care Delirium Screening Checklist will be measured at study initiation, after 2 hours, at study completion (4 hours) and the start of the following nursing shift
Richmond Agitation Sedation Scale of zero
Proportion of patients achieving a Richmond Agitation Sedation Scale score of zero throughout the study period. Score range is -5 to +4 with a score of zero indicating the patient is awake and calm. Negative scores indicate deeper sedation, positive scores reflect agitation
Physical Restraint Use
Proportion of participants with physical restraints in use throughout the study period and the length of time of restraints in use
Incidence of Unplanned Line removal
Incidence of unplanned removal of lines or tubes by the study participant (endotracheal tubes, nasogastric tubes, oral-gastric tubes, central venous lines, peripheral intravenous lines, urinary catheters, arterial lines) throughout the study period.
PRN medication use in the 2 hours post study
Incidence of unscheduled medication administration for the management of delirium behaviors in the 2 hours following the study or intervention period.
Movement Count Average
Those in the intervention arm will have generated activity logs stored within the device units. The movement count average is calculated by comparing the difference in pixel density from the previous frame to the current one. The resulting value is then averaged over the collected frames and returned as a decimal percentage of change. Values are between 0 and 1 with 0 showing the lowest amount of activity and one the highest
Physiological data
Basic physiological data will be collected and analyzed from nursing records and for a smaller proportion directly from telemetry monitors where available to compare between arms as well as to evaluate trends over the course of the study period. Parameters include heart rate, mean arterial blood pressure, respiratory rate, oxygen saturation and use of vasopressors
heart rate variability
For a small subset of the overall population ECG data will be collected to assess differences in heart rate variability between study arms measured as pNN50 and RMMSD. Five minute ECG recordings will be taken hourly starting one hour before the study period until one hour post timed to match agitation and delirium scores
Full Information
NCT ID
NCT04652622
First Posted
November 17, 2020
Last Updated
January 4, 2023
Sponsor
Fraser Health
Collaborators
BC Support Unit, Royal Columbian Hospital Foundation, Mitacs
1. Study Identification
Unique Protocol Identification Number
NCT04652622
Brief Title
Use of a Novel Digital Therapeutic Intervention for the Management of Delirium in the Acute Care Environment
Official Title
Use of a Novel Digital Therapeutic Intervention for the Management of Delirium in the Acute Care Environment
Study Type
Interventional
2. Study Status
Record Verification Date
January 2023
Overall Recruitment Status
Completed
Study Start Date
March 16, 2021 (Actual)
Primary Completion Date
January 5, 2022 (Actual)
Study Completion Date
December 5, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Fraser Health
Collaborators
BC Support Unit, Royal Columbian Hospital Foundation, Mitacs
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
Detailed Description
Mindful Garden is a digital behavior modification platform that utilizes screen based delivery systems and sensor technologies. Mindful Garden delivers real 2-dimensional nature video layered with hyper-real 3-dimensional animations of growing and receding flowers and butterflies in flight which aims to reduce anxiety and agitation in the delirious critical care population. In doing so, normalization of agitation and delirium scores may be achieved as well as a reduction in reliance on pharmacological interventions and the use of physical restraints, which have been linked to adverse outcomes and significant side effects.
Participants with a diagnosis of hyperactive delirium in acute care inpatient units will be randomized to receive 4 hours of exposure to the MG platform in addition to standard care or to the control arm of monitoring with standard care only for the same time period.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Delirium
Keywords
digital therapeutic, behavioral, critical care, behavior modification
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
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
Masking
Outcomes Assessor
Masking Description
data will be blinded for analysis but the study is open label due to the nature of the intervention
Allocation
Randomized
Enrollment
70 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Intervention arm
Arm Type
Experimental
Arm Description
Participants will receive 4 hours of exposure to the Mindful Garden digital therapeutic platform in addition to standard care
Arm Title
Control Arm
Arm Type
No Intervention
Arm Description
Participants will be monitored over a 4 hour period of standard care interventions
Intervention Type
Device
Intervention Name(s)
Mindful Garden
Intervention Description
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.
Primary Outcome Measure Information:
Title
Agitation scores
Description
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.
Time Frame
5 hours
Secondary Outcome Measure Information:
Title
Use of unscheduled medications for the management of delirium associated agitation
Description
Incidence of unscheduled or "PRN" medication use for the management of delirium associated agitation throughout the 4 hour study period
Time Frame
4 hours
Title
Delirium Scores
Description
Delirium scores will be measured using the Intensive Care Delirium Screening Checklist. Delirium score is a range of zero to 8 with scores above or equal to 4 being diagnostic for the presence of delirium and higher scores being indicative of added severity of symptoms. Intensive Care Delirium Screening Checklist will be measured at study initiation, after 2 hours, at study completion (4 hours) and the start of the following nursing shift
Time Frame
4 hours
Title
Richmond Agitation Sedation Scale of zero
Description
Proportion of patients achieving a Richmond Agitation Sedation Scale score of zero throughout the study period. Score range is -5 to +4 with a score of zero indicating the patient is awake and calm. Negative scores indicate deeper sedation, positive scores reflect agitation
Time Frame
4 hours
Title
Physical Restraint Use
Description
Proportion of participants with physical restraints in use throughout the study period and the length of time of restraints in use
Time Frame
4 hours
Title
Incidence of Unplanned Line removal
Description
Incidence of unplanned removal of lines or tubes by the study participant (endotracheal tubes, nasogastric tubes, oral-gastric tubes, central venous lines, peripheral intravenous lines, urinary catheters, arterial lines) throughout the study period.
Time Frame
4 hours
Title
PRN medication use in the 2 hours post study
Description
Incidence of unscheduled medication administration for the management of delirium behaviors in the 2 hours following the study or intervention period.
Time Frame
2 hours
Title
Movement Count Average
Description
Those in the intervention arm will have generated activity logs stored within the device units. The movement count average is calculated by comparing the difference in pixel density from the previous frame to the current one. The resulting value is then averaged over the collected frames and returned as a decimal percentage of change. Values are between 0 and 1 with 0 showing the lowest amount of activity and one the highest
Time Frame
4 Hours
Title
Physiological data
Description
Basic physiological data will be collected and analyzed from nursing records and for a smaller proportion directly from telemetry monitors where available to compare between arms as well as to evaluate trends over the course of the study period. Parameters include heart rate, mean arterial blood pressure, respiratory rate, oxygen saturation and use of vasopressors
Time Frame
4 hours
Title
heart rate variability
Description
For a small subset of the overall population ECG data will be collected to assess differences in heart rate variability between study arms measured as pNN50 and RMMSD. Five minute ECG recordings will be taken hourly starting one hour before the study period until one hour post timed to match agitation and delirium scores
Time Frame
6 hours
Other Pre-specified Outcome Measures:
Title
Survey of caregivers
Description
a 5 question survey of caregivers will be conducted using a 9 point Likert scale evaluating the ease of use of the intervention and acceptability of the intervention. On the scale 1 indicates strongly disagree to 9 indicating strongly agree, 5 being neutral. The questionnaire will be conducted at the end of the study period where possible
Time Frame
4 hours
Title
Survey of family members
Description
a 5 question survey of family members if present during exposure to the intervention will be conducted using a 9 point Likert scale evaluating acceptability of the intervention. On the scale 1 indicates strongly disagree to 9 indicating strongly agree, 5 being neutral
Time Frame
4 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Steven Reynolds
Organizational Affiliation
Fraser Health Authority
Official's Role
Principal Investigator
Facility Information:
Facility Name
Royal Columbian Hospital
City
New Westminster
State/Province
British Columbia
ZIP/Postal Code
V3L 3W7
Country
Canada
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Use of a Novel Digital Therapeutic Intervention for the Management of Delirium in the Acute Care Environment
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