DeliriumNCT04652622
Use of a Novel Digital Therapeutic Intervention for the Management of Delirium in the Acute Care Environment
A study testing Mindful Garden in people with Delirium, run by Fraser Health at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Delirium
- What is being tested?
- Mindful Garden
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteCanada
- Study dates
- 16 Mar 2021to 5 Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Canada1 site
Royal Columbian Hospital
New Westminster, British Columbia, V3L 3W7
About this study
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.
Read the 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.
- Conditions
- Delirium
- Being tested
- Mindful Garden
- Keywords
- digital therapeutic, behavioral, critical care, behavior modification
- Medical subject headings
- Delirium, Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mindful GardenDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention arm | Experimental | Participants will receive 4 hours of exposure to the Mindful Garden digital therapeutic platform in addition to standard care Receives: Device: Mindful Garden |
| Control Arm | No intervention | Participants will be monitored over a 4 hour period of standard care interventions |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 5 hours
Secondary outcomes (9)
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
Measured: 4 hours
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
Measured: 4 hours
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
Measured: 4 hours
Physical Restraint Use
Proportion of participants with physical restraints in use throughout the study period and the length of time of restraints in use
Measured: 4 hours
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.
Measured: 4 hours
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.
Measured: 2 hours
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
Measured: 4 Hours
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
Measured: 4 hours
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
Measured: 6 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2020
- Study start16 Mar 2021
- Primary completion5 Jan 2022
- Study completion5 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DeliriumStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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 blind
- Who is masked
- Outcomes assessor
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fraser Health
- Sponsor type
- University, hospital or other
- Collaborators
- BC Support Unit, Royal Columbian Hospital Foundation, Mitacs
- Responsible party
- Sponsor
- Investigators
- Steven Reynolds, Principal investigator, Fraser Health Authority
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04652622
- Sponsor's protocol ID
- FHREB 2020-091
- Status last verified
- Jan 2023
- First submitted
- 17 Nov 2020
- Last updated
- 6 Jan 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of a Novel Digital Therapeutic Intervention for the Management of Delirium in the Acute Care Environment
- ClinicalTrials.gov ID
- NCT04652622
- Acronym / sponsor ID
- FHREB 2020-091
- Conditions
- Delirium
- Keywords
- digital therapeutic, behavioral, critical care, behavior modification
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Fraser HealthUniversity, hospital or other
- Collaborators
- BC Support Unit, Royal Columbian Hospital Foundation, Mitacs
- Study start
- 16 Mar 2021 (actual)
- Primary completion
- 5 Jan 2022 (actual)
- Study completion
- 5 Dec 2022 (actual)
- First posted
- 3 Dec 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- 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
| Arm | Type | Receives |
|---|---|---|
| Intervention arm | Experimental | Device: Mindful GardenParticipants will receive 4 hours of exposure to the Mindful Garden digital therapeutic platform in addition to standard care |
| Control Arm | No intervention | –Participants will be monitored over a 4 hour period of standard care interventions |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mindful GardenMindful 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. | Device | Intervention arm |
Primary outcome
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.
9 secondary outcomes
Use of unscheduled medications for the management of delirium associated agitation
Time frame: 4 hours
Delirium Scores
Time frame: 4 hours
Richmond Agitation Sedation Scale of zero
Time frame: 4 hours
Physical Restraint Use
Time frame: 4 hours
Incidence of Unplanned Line removal
Time frame: 4 hours
PRN medication use in the 2 hours post study
Time frame: 2 hours
Movement Count Average
Time frame: 4 Hours
Physiological data
Time frame: 4 hours
heart rate variability
Time frame: 6 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jan 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Steven Reynolds principal investigator
Fraser Health Authority
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mindful Garden in people with Delirium, run by Fraser Health at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Agitation scores (time frame: 5 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jan 2023.