MindfulGarden in Treatment of Hyperactive Delirium in a Hospital Setting

• ClinicalTrials.gov Identifier: NCT03621228
• Recruitment Status: Unknown
• First Posted: August 8, 2018
• Last Update Posted: August 13, 2018
• Sponsor: Simon Fraser University
• Information provided by (Responsible Party): Gloria Gutman, Simon Fraser University

Study Description

Brief Summary:

This pilot study is designed to address feasibility for a larger randomized control clinical study that will determine the efficacy of exposure to the MindfulGarden - an interactive digital technology - in reducing hyperactive delirium in hospitalized older adults.

Condition or disease	Intervention/treatment	Phase
Hyperactive Delirium	Device: MindfulGarden	Not Applicable

Detailed Description:

The primary objective of the study is to establish whether the key components necessary for conducting a full randomized control study in the future, such as recruitment, consent, randomization, and treatment processes are working well and all function together. As a secondary objective, the investigators will determine trends in patients exposed to MindfulGarden (MG), for example:

1. At the first and second administration of the Confusion Assessment Method - short form (CAM) after admission to a medical ward are there more, the same or fewer patients in the intervention group than in the control group whose CAM scores change from positive to negative?
2. During the first 24 hours after admission to a medical ward, did fewer, the same, or a greater number of patients in the intervention than in the control group experience significant events/alerts (e.g. aggressive/violent behaviours, falls, code white)?
3. During the first 24 hours after admission to a medical ward, were fewer, the same, or a greater number of patients in the intervention than in the control group administered psychotropic drugs (e.g. haloperidol, risperidone, quetiapine, lorazepam)? were more, the same, or fewer administered sleeping aids (e.g. trazodone, melatonin)?
4. During the first 24 hours after admission to a medical ward, were fewer, the same, or a greater number of patients in the intervention than in the control group physically restrained?
5. Was mean length of stay from time of admission to a medical ward until discharge due to death, return to place of residence before admission or to a different place of residence longer, the same or shorter in the intervention than in the control group?
6. Were there more, the same or fewer deaths or discharges to a higher level of care (e.g. to assisted living, to a complex care facility in patients who previously lived at home) in the intervention than the control group?

Additionally, to the extent that movement and vocalization are reflective of anxiety, agitation and/or aggression (i.e. responsive behaviours) the investigators also want to determine whether there is a correlation between changes in these as recorded by the MG and any of the indicators listed in 1-6 above.

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 24 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Supportive Care
• Official Title: A Pilot Study of an Interactive Digital Technology (MindfulGarden) in Treatment of Hyperactive Delirium in a Hospital Setting
• Estimated Study Start Date: September 2018
• Estimated Primary Completion Date: March 2019
• Estimated Study Completion Date: April 2019

Arms and Interventions

Arm	Intervention/treatment
Experimental: MindfulGarden; Standard care + exposure to an interactive digital device	Device: MindfulGarden; MindfulGarden (MG) is an interactive digital technology that combines use of a smart television with sensors to intelligently generate content based on patient voice and gesture input, triggering a multi-layered visual 'garden' on-screen to arrest and de-escalate anxiety and aggression in treatment of hospitalized elderly diagnosed with hyperactive delirium.
No Intervention: Control; Standard care only

Outcome Measures

Primary Outcome Measures :

1. Recruitment Rates [ Time Frame: Number enrolled within 12 hours of admission to Emergency Department ]
   Number of participants approached and their rate of consent

Secondary Outcome Measures :

1. Estimate the potential effect size [ Time Frame: 24-hour period following transfer from Emergency Department ]
   MG association with reducing delirium duration as measured CAM - short
2. Adverse Outcomes (number of patients with aggressive/violent behaviours, falls, code white) [ Time Frame: 24-hour period following transfer from Emergency Department ]
   Assess from patients medical chart
3. Psychotropic Drug Consumption [ Time Frame: 24-hour period following transfer from Emergency Department ]
   Assess from patient's medical chart
4. Application of Physical Restraints [ Time Frame: 24-hour period following transfer from Emergency Department ]
   Assess from patient's medical chart
5. Length of Stay [ Time Frame: Date of study enrolment through to discharge from hospital, or date of study enrolment up to 30 days ]
   Assess from patient's medical chart

Eligibility Criteria

• Ages Eligible for Study: 65 Years and older (Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

Inclusion Criteria:

- All patients aged 65 years or older admitted to the Emergency Department who have a diagnosis of hyperactive delirium as defined by the short CAM

Exclusion Criteria:

• Patients with severe vision impairment or who are legally blind
• Patients for whom a bed in a medical ward was not available within 12 hours of a diagnosis of hyperactive delirium (i.e. who remained in the Emergency Department more than 12 hours)

Contacts and Locations

Contacts

Contact: Gloria Gutman, PhD; 778.782.5063; gutman@sfu.ca

Contact: Fabio Feldman, PhD; 6045877850; fabio.feldman@fraserhealth.ca

Sponsors and Collaborators

Simon Fraser University

Investigators

• Principal Investigator: Gloria Gutman; Simon Fraser University

More Information

• Responsible Party: Gloria Gutman, Professor Emerita, Simon Fraser University
• ClinicalTrials.gov Identifier: NCT03621228
• Other Study ID Numbers: MindfulGarden-H-Pilot
• First Posted: August 8, 2018
• Last Update Posted: August 13, 2018
• Last Verified: August 2018

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Gloria Gutman, Simon Fraser University:

Delirium; Hyperactive; Aggression; Anxiety; Digital therapy

Additional relevant MeSH terms:

Delirium; Hyperkinesis; Psychomotor Agitation; Confusion; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Neurocognitive Disorders; Mental Disorders; Dyskinesias; Psychomotor Disorders