DeliriumACTIVATENCT07896356
Family-partnered Delirium Prevention, Detection, and Management in the ICU
A study testing Delirium Education, Prevention, and Management in people with Delirium and Intensive Care Unit Delirium, run by University of Calgary at 1 site in Canada.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Delirium, Intensive Care Unit Delirium, Post Intensive Care Unit Syndrome
- What is being tested?
- Delirium Education, Prevention, and Management
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 1,344 participants
- Where
- 1 siteCanada
- Study dates
- 1 Feb 2027to 1 Feb 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
Patient Inclusion Criteria:
- 18 years of age or older
- Richmond Agitation-Sedation Scale (RASS) score of equal to or greater than -3
- Anticipated to remain admitted to the ICU for at least a further 48 hours to complete study assessments at least once
- Family involvement
- Able to communicate with research staff (in English or French, or with the assistance of a translator or interpreter)
- Able to provide informed consent (surrogate consent possible)
Family Inclusion Criteria:
- 18 years of age or older
- Able to communicate with research staff (in English or French, or with the assistance of a translator or interpreter)
- Available at least once daily for up to five study days (study days do not have to be continuous)
Patient Exclusion Criteria:
- Deep sedation or coma (RASS score of -4 or -5)
- Anticipated to remain admitted to the ICU for less than 48 hours
- Moderate or severe traumatic brain injury (as judged by the most responsible physician or a designated clinical physician involved in the patient's care)
- Already admitted to the ICU during study control or intervention periods (i.e., no readmissions)
- Moribund
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site
Foothills Medical Centre
Calgary, Alberta, T2N 2T9
KArla Krewulak, Ph.D., 403-944-8768, kkrewula@ucalgary.ca
Olivia Morassutti, M.Sc., 403-944-5973, olivia.morassutti@ucalgary.ca
About this study
Official title: Family-partnered Delirium Prevention, Detection, and Management in the ICU: A Stepped-wedge Cluster Randomized Trial
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.
Read more
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:
- Reducing psychological distress in family members,
- Reducing the prevalence, duration, and severity of delirium in critically ill patients,
- Increasing delirium identification in medical charts,
- Increasing delirium knowledge in family members of critically ill patients, and
- Reducing the burden of delirium experienced by family members and caregivers
Read the detailed description
This study is a fourteen-site Canadian stepped-wedge cluster randomized controlled trial. The unit of randomization is a cluster, with each cluster comprising two ICUs. Fourteen ICUs will be grouped into seven clusters and randomized to one of seven sequences to determine the timing of crossover from the control condition to intervention condition. The study is comprised of eight three-month periods, during which clusters will sequentially cross over until all clusters have implemented the intervention. The order in which ICUs enter the intervention condition will be randomized prior to enrolment of the first study patient. Eligible patients admitted to eight Canadian ICUs, with at least one family member present, will be identified by discussion with the most responsible attending physician and bedside nurse. Once enrolled in the study, patients will be assessed for eligibility daily (see Eligibility section). If patients meet eligibility criteria, study procedures will proceed. If patients do not meet eligibility, the study will be paused, and study days (the up to five days where participation occurs) will not accumulate until they become eligible for the intervention again (they will be reassessed the following day).
All eligible and consenting patients and family members will receive standard of care, which varies by site, but includes guideline-recommended interventions. Patients and family members in both the control and intervention groups will complete demographic questionnaires, whereas only family members will complete the Patient Health Questionnaire-9 (PHQ-9), the Generalized Anxiety Disorder-7 (GAD-7), Short Form Informant Questionnaire on Cognitive Decline in the Elderly (Short IQCODE), and a family presence questionnaire. The PHQ-9, GAD-7, and family presence questionnaire will be completed daily for a maximum of five study days, which may not be consecutive in nature.
Family members in the intervention group will receive an ICU delirium bundle, which will include education on delirium management, prevention, and detection. Family members will receive delirium education by watching a six-minute video or reading a booklet detailing the signs and symptoms of delirium, who is at risk, and how delirium can be managed and prevented. They will practice identifying delirium using the Family ICU Delirium Detection Instrument (FIDDI) with case vignettes of hypothetical ICU patients. Delirium prevention and management will include a daily checklist of non-pharmacological methods to prevent delirium, completed by the family member. This will include an orientation protocol (e.g., provide visual and hearing aids, orientation of day/time/location, bringing in familiar objects from home, etc.), mobility protocol (e.g., cognitive activities depending on the patient's abilities), and an environmental protocol (e.g., lights off at night and on during the day, ear plugs, noise reduction during the night, etc.). The checklist will be completed daily for a maximum of five study days, which may not be consecutive in nature.
Family members in both the control and intervention groups will also complete follow-up questionnaires (PHQ-9 and GAD-7) 3-months following the discharge for their loved one from the ICU. In order to maintain participant engagement, biweekly check-ins and monthly newsletters with study updates will be implemented, starting from the time from which the patient is discharged from the ICU.
- Conditions
- Delirium, Intensive Care Unit Delirium, Post Intensive Care Unit Syndrome, Post Intensive Care Unit Syndrome Family
- Being tested
- Standard of Care, Delirium Education, Prevention, and Management
- Keywords
- Delirium, Intensive Care Unit, Critically Ill, Delirium Detection, Delirium Prevention, Delirium Education, Delirium Management, Psychological Distress, Post Intensive Care Unit Syndrome, Post Intensive Care Unit Syndrome Family
- Medical subject headings
- Delirium, Critical Illness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard of CareBehavioural
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.
Delirium Education, Prevention, and ManagementBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Control Group | Placebo comparator | 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. Receives: Behavioral: Standard of Care |
| Intervention Group | Experimental | 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. Receives: Behavioral: Standard of Care; Behavioral: Delirium Education, Prevention, and Management |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 3-months post-ICU discharge
Secondary outcomes (5)
Clinically significant depression symptoms (family)
Change in proportion of major depressive disorder symptamology in family members of critically ill patients measured by the Patient Health Questionnaire-9 (PHQ-9) scores, compared between control and intervention
Measured: Up to five days and at 3-months post patient ICU discharge
Clinically significant symptoms anxiety (family)
Change in proportion of generalized anxiety symptomatology in family members of critically ill patients measured by the Generalized Anxiety Disorder-7 (GAD-7) scores, compared between the control group and the intervention
Measured: Up to five days and at 3-months post patient ICU discharge
Delirium or coma free days (patients)
Clinical delirium assessment measured by the Confusion Assessment Method for the ICU (CAM-ICU) or the Intensive Care Delirium Screening Checklist (ICDSC) scores, compared between control and intervention Coma free days measured by the number of days after enrolment that a patient is alive without delirium or coma, compared between control and intervention
Measured: Up to five days
Time to both ICU and hospital discharge (patients)
Number of days between ICU admission and discharge from the ICU and/or hospital, compared between control and intervention
Measured: Up to five days
Cumulative dose of pain medications, antipsychotics, and sedatives (patients)
Medications measured in milligrams per 24 hours, compared between control and intervention
Measured: Up to five days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2026
- Study start1 Feb 2027 (estimated)
- Primary completion1 Feb 2030 (estimated)
- Study completion1 Feb 2030 (estimated)
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.
- More trials run by University of CalgaryThe sponsor's other registered studies.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Model description
- The design of this study is a stepped-wedge cluster randomized trial. This study involves the sequential transition of clusters (i.e., ICU sites) from control condition to intervention condition until all clusters are exposed, with the order of transition randomly determined. The unit of randomization is a cluster, with each cluster comprising two ICUs. Fourteen ICUs will be grouped into seven clusters and randomized to one of seven sequences to determine the timing of crossover from the control condition to intervention condition, according to the stepped-wedge allocation schedule. The study is comprised of eight three-month periods, during which clusters will sequentially cross over until all clusters have implemented the intervention.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 1,344 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Calgary
- Sponsor type
- University, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR), University of Alberta
- Responsible party
- Principal investigator, Kirsten Fiest, University of Calgary
- Investigators
- Kirsten Fiest, Ph.D., Principal investigator, University of Calgary
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07896356
- Sponsor's protocol ID
- REB25-0978
- Acronym
- ACTIVATE
- Status last verified
- Oct 2026
- First submitted
- 20 Oct 2026
- Last updated
- 27 Oct 2026
- 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 27 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Family-partnered Delirium Prevention, Detection, and Management in the ICU: A Stepped-wedge Cluster Randomized Trial
- ClinicalTrials.gov ID
- NCT07896356
- Acronym / sponsor ID
- ACTIVATE / REB25-0978
- Conditions
- Delirium, Intensive Care Unit Delirium, Post Intensive Care Unit Syndrome, Post Intensive Care Unit Syndrome Family
- Keywords
- Delirium, Intensive Care Unit, Critically Ill, Delirium Detection, Delirium Prevention, Delirium Education, Delirium Management, Psychological Distress
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 1,344 participants (estimated)
- Lead sponsor
- University of CalgaryUniversity, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR), University of Alberta
- Study start
- 1 Feb 2027 (estimated)
- Primary completion
- 1 Feb 2030 (estimated)
- Study completion
- 1 Feb 2030 (estimated)
- First posted
- 27 Oct 2026 (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.
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:
- Reducing psychological distress in family members,
- Reducing the prevalence, duration, and severity of delirium in critically ill patients,
- Increasing delirium identification in medical charts,
- Increasing delirium knowledge in family members of critically ill patients, and
- Reducing the burden of delirium experienced by family members and caregivers
Detailed description
This study is a fourteen-site Canadian stepped-wedge cluster randomized controlled trial. The unit of randomization is a cluster, with each cluster comprising two ICUs. Fourteen ICUs will be grouped into seven clusters and randomized to one of seven sequences to determine the timing of crossover from the control condition to intervention condition. The study is comprised of eight three-month periods, during which clusters will sequentially cross over until all clusters have implemented the intervention. The order in which ICUs enter the intervention condition will be randomized prior to enrolment of the first study patient. Eligible patients admitted to eight Canadian ICUs, with at least one family member present, will be identified by discussion with the most responsible attending physician and bedside nurse. Once enrolled in the study, patients will be assessed for eligibility daily (see Eligibility section). If patients meet eligibility criteria, study procedures will proceed. If patients do not meet eligibility, the study will be paused, and study days (the up to five days where participation occurs) will not accumulate until they become eligible for the intervention again (they will be reassessed the following day).
All eligible and consenting patients and family members will receive standard of care, which varies by site, but includes guideline-recommended interventions. Patients and family members in both the control and intervention groups will complete demographic questionnaires, whereas only family members will complete the Patient Health Questionnaire-9 (PHQ-9), the Generalized Anxiety Disorder-7 (GAD-7), Short Form Informant Questionnaire on Cognitive Decline in the Elderly (Short IQCODE), and a family presence questionnaire. The PHQ-9, GAD-7, and family presence questionnaire will be completed daily for a maximum of five study days, which may not be consecutive in nature.
Family members in the intervention group will receive an ICU delirium bundle, which will include education on delirium management, prevention, and detection. Family members will receive delirium education by watching a six-minute video or reading a booklet detailing the signs and symptoms of delirium, who is at risk, and how delirium can be managed and prevented. They will practice identifying delirium using the Family ICU Delirium Detection Instrument (FIDDI) with case vignettes of hypothetical ICU patients. Delirium prevention and management will include a daily checklist of non-pharmacological methods to prevent delirium, completed by the family member. This will include an orientation protocol (e.g., provide visual and hearing aids, orientation of day/time/location, bringing in familiar objects from home, etc.), mobility protocol (e.g., cognitive activities depending on the patient's abilities), and an environmental protocol (e.g., lights off at night and on during the day, ear plugs, noise reduction during the night, etc.). The checklist will be completed daily for a maximum of five study days, which may not be consecutive in nature.
Family members in both the control and intervention groups will also complete follow-up questionnaires (PHQ-9 and GAD-7) 3-months following the discharge for their loved one from the ICU. In order to maintain participant engagement, biweekly check-ins and monthly newsletters with study updates will be implemented, starting from the time from which the patient is discharged from the ICU.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- The design of this study is a stepped-wedge cluster randomized trial. This study involves the sequential transition of clusters (i.e., ICU sites) from control condition to intervention condition until all clusters are exposed, with the order of transition randomly determined. The unit of randomization is a cluster, with each cluster comprising two ICUs. Fourteen ICUs will be grouped into seven clusters and randomized to one of seven sequences to determine the timing of crossover from the control condition to intervention condition, according to the stepped-wedge allocation schedule. The study is comprised of eight three-month periods, during which clusters will sequentially cross over until all clusters have implemented the intervention.
| Arm | Type | Receives |
|---|---|---|
| Control Group | Placebo comparator | Behavioral: Standard of CarePatients 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. |
| Intervention Group | Experimental | Behavioral: Standard of Care, Behavioral: Delirium Education, Prevention, and ManagementPatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| Standard of CarePatients 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. | Behavioural | Control Group, Intervention Group |
| Delirium Education, Prevention, and ManagementPatients 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. | Behavioural | Intervention Group |
Primary outcome
Family member symptoms of depression and anxiety
Time frame: 3-months post-ICU discharge
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
5 secondary outcomes
Clinically significant depression symptoms (family)
Time frame: Up to five days and at 3-months post patient ICU discharge
Clinically significant symptoms anxiety (family)
Time frame: Up to five days and at 3-months post patient ICU discharge
Delirium or coma free days (patients)
Time frame: Up to five days
Time to both ICU and hospital discharge (patients)
Time frame: Up to five days
Cumulative dose of pain medications, antipsychotics, and sedatives (patients)
Time frame: Up to five days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2026.
- 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.
Kirsten Fiest, Ph.D. principal investigator
University of Calgary
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Delirium Education, Prevention, and Management in people with Delirium and Intensive Care Unit Delirium, run by University of Calgary 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?
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: opening soon, as of the sponsor's last update on 27 Oct 2026. 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. Some participants in this study may receive a placebo. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Karla Krewulak, Ph.D. (403-944-8768, kkrewula@ucalgary.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Family member symptoms of depression and anxiety (time frame: 3-months post-ICU discharge). 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 27 Oct 2026.