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ACTIVATE
Sponsor study identifier
interventional
1,344
1 country
1
Study Start
February 1, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Primary Completion
February 1, 2030
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
February 1, 2030
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Almost half of critically ill patients experience delirium. Delirium is associated with impaired cognition, mortality, and increased healthcare costs. Family members of critically ill patients are also at risk for adverse consequences such as depression and anxiety. One strategy that may help to improve outcomes is to engage family members in the prevention, detection, and management of delirium. This study will employ an educational module to educate families on delirium symptoms, how delirium can be identified, and how to prevent and manage delirium using non-pharmacological strategies. Family member delirium detection may result in earlier and more accurate recognition of delirium as well as meaningful family involvement, and ultimately the potential for better patient and family outcomes. This study aims to determine the efficacy of employing family-administered delirium prevention, detection, and management in the critically ill, compared to standard of care. We hypothesize that family-administered delirium prevention, detection, and management in the critically ill will be superior to standard of care in:
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
February 1, 2030
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
October 20, 2026
Actual (reported)October 27, 2026
Actual (reported)February 1, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
February 1, 2030
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
February 1, 2030
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Family member symptoms of depression and anxiety
Change in the proportion of major depressive disorder and generalized anxiety symptamology in family members of critical ill patients measured by the Patient Health Questionnaire-Anxiety and Depression Scale (PHQ-ADS) scores, compared between control and intervention
3-months post-ICU discharge
Clinically significant depression symptoms (family)
Up to five days and at 3-months post patient ICU discharge
Clinically significant symptoms anxiety (family)
Up to five days and at 3-months post patient ICU discharge
Patients and family caregivers will receive standard of care, which varies by study site, but includes guideline-recommended interventions by the clinical team to prevent and manage delirium.
Patients and family caregivers will receive standard of care, which varies by study site, but includes guideline-recommended interventions by the clinical team to prevent and manage delirium. Additionally, they will receive a family-partnered delirium care intervention comprised of two components: 1) Education and 2) Family administered delirium prevention, detection, and management activities.
Patients and family caregivers will receive standard of care, which varies by study site, but includes guideline-recommended interventions by the clinical team to prevent and manage delirium.
Patients and family caregivers will be provided with a validated education module on the signs and risk factors of delirium, in addition to delirium detection, prevention, and management strategies. The material will be provided as a six-minute video or as a paper booklet. Families will practice identifying delirium with the Family ICU Delirium Detection Instrument (FIDDI), using previously validated case vignettes of hypothetical ICU patients. Family caregivers will also be provided with a daily checklist to complete, detailing non-pharmacological strategies to prevent and manage delirium (i.e., orientation, mobility, and environmental cues). Delirium detection by family caregivers will be assessed by the FIDDI and communicated to the bedside nurse.
Foothills Medical Centre
Calgary, Alberta, T2N 2T9, Canada
Kirsten Fiest, Ph.D.
University of Calgary
First Submitted
October 20, 2026
Delirium or coma free days (patients)
Up to five days
Time to both ICU and hospital discharge (patients)
Up to five days
Cumulative dose of pain medications, antipsychotics, and sedatives (patients)
Up to five days
Contact the study team to confirm eligibility.
First Posted
October 27, 2026
Study Start
February 1, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Primary Completion
February 1, 2030
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
February 1, 2030
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Last Updated
October 27, 2026
Record last verified: 2026-10
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Source: ClinicalTrials.gov.
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