Use of a Novel Digital Therapeutic Intervention for the Management of Delirium in the Acute Care Environment
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|ClinicalTrials.gov Identifier: NCT04652622|
Recruitment Status : Recruiting
First Posted : December 3, 2020
Last Update Posted : January 24, 2022
|Condition or disease||Intervention/treatment||Phase|
|Delirium||Device: Mindful Garden||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||70 participants|
|Intervention Model:||Parallel Assignment|
|Intervention 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:||Single (Outcomes Assessor)|
|Masking Description:||data will be blinded for analysis but the study is open label due to the nature of the intervention|
|Official Title:||Use of a Novel Digital Therapeutic Intervention for the Management of Delirium in the Acute Care Environment|
|Actual Study Start Date :||April 1, 2021|
|Estimated Primary Completion Date :||January 2022|
|Estimated Study Completion Date :||January 2022|
Experimental: Intervention arm
Participants will receive 4 hours of exposure to the Mindful Garden digital therapeutic platform in addition to standard care
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.
No Intervention: Control Arm
Participants will be monitored over a 4 hour period of standard care interventions
- Agitation scores [ Time Frame: 5 hours ]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.
- Use of unscheduled medications for the management of delirium associated agitation [ Time Frame: 4 hours ]Incidence of unscheduled or "PRN" medication use for the management of delirium associated agitation throughout the 4 hour study period
- Delirium Scores [ Time Frame: 4 hours ]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 [ Time Frame: 4 hours ]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 [ Time Frame: 4 hours ]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 [ Time Frame: 4 hours ]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 [ Time Frame: 2 hours ]Incidence of unscheduled medication administration for the management of delirium behaviors in the 2 hours following the study or intervention period.
- Movement Count Average [ Time Frame: 4 Hours ]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 [ Time Frame: 4 hours ]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 [ Time Frame: 6 hours ]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
- Survey of caregivers [ Time Frame: 4 hours ]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
- Survey of family members [ Time Frame: 4 hours ]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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04652622
|Contact: Michelle Nicholas, PhD(c)||email@example.com|
|Contact: Suzette Willemsfirstname.lastname@example.org|
|Canada, British Columbia|
|Royal Columbian Hospital||Recruiting|
|New Westminster, British Columbia, Canada, V3L 3W7|
|Contact: Sue Willems, BScN 604-520-4695|
|Contact: Michelle Nicholas, MSc 7782310739 email@example.com|
|Principal Investigator: Steven Reynolds, MD|
|Principal Investigator:||Steven Reynolds||Fraser Health Authority|