DeliriumNCT04099472
Partnering With Family Members to Prevent, Detect and Manage Delirium in Critically Ill Patients.
A study testing Delirium Education, Prevention, and Management in people with Delirium and Intensive Care Unit Delirium, run by University of Calgary at 4 sites 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
- 128 participants
- Where
- 4 sitesCanada
- Study dates
- 13 Jan 2020to 31 Jan 2024
- 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
- Intensive care unit (ICU) patients aged 18+ anticipated to remain admitted in the ICU for at least a further 24 hours to complete the intervention and all assessments at least once
- ICU patient has a caregiver (i.e., family member or friend) present
- Richmond Agitation Sedation Scale (RASS) ≥-3
- The ability to provide informed consent (both patient and family member; surrogate consent possible)
- The ability to communicate with research staff (fluent in English, no hearing or visual impairment that precludes communication)
Who cannot join
- Primary direct brain injury (e.g., traumatic brain injury, subarachnoid hemorrhage) with a Glasgow Coma Scale score of <9
Trial locations and contacts
4 sites in 1 country.
Canada4 sites
Peter Lougheed Centre ICU
Calgary, Alberta, T2N 1N4
Foothills Medical Centre
Calgary, Alberta, T2N 2T9
Rockyview General Hospital
Calgary, Alberta, T2V 1P9
South Health Campus
Calgary, Alberta, T3M 1M4
About this study
Official title: Family-administered Delirium Prevention, Detection, and Management in the Critically Ill: a Randomized Control 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 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 to identify delirium, and how to prevent and manage delirium using non-pharmacological strategies.
Read more
Family delirium detection may result in earlier and more accurate recognition of delirium and meaningful family involvement, and therein the potential for better patient and family outcomes. We aim to determine the efficacy of employing family-administered delirium prevention, detection, and management in the critically ill, compared to usual 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 will be a parallel-group randomized control trial with a 1:1 allocation ratio. Consecutive, eligible patients admitted to 4 ICUs in Calgary, Alberta, Canada with at least one family member present will be identified by discussion with the most responsible attending physician and bedside nurse. All eligible and consenting family members will receive standard care, which is an informational pamphlet on ICU delirium presented to all patients and families upon admission. Participants in both the intervention and control groups will also complete a demographics questionnaire, the Critical Care Family Needs Inventory (CCFNI), the Barriers to Care Questionnaire in the ICU (BCQ-ICU), the Caregiver Coping Strategies (CSS) questionnaire, and the Caregiver ICU Delirium Knowledge Questionnaire (CIDKQ) upon enrollment. Additionally, all family members will complete the Delirium Burden (DEL-B) questionnaire, Kessler Psychological Distress Scale (KPDS-10), Patient Health Questionnaire 9 (PHQ-9), Generalized Anxiety Disorder 7 (GAD-7) daily for a maximum of five days.
Family members randomized to the intervention group will receive additional ICU delirium education, whereas the control group will not. The intervention includes components of delirium education, prevention/management and detection. Family members will receive education by watching a 6-minute education video or reading an education booklet with a trained research assistant on the signs of delirium, who is at risk, and what they can do to prevent and manage it. They will practice identifying delirium with the Sour Seven questionnaire using previously validated case vignettes of hypothetical ICU patients. Delirium prevention and management will include a daily checklist of non-pharmacological interventions to be completed by the family member. This will include an orientation protocol (e.g., provide visual and hearing aids, orientation of day/time/location, familiar objects from home, television during the day with daily news, non-verbal music), mobility protocol (cognitive activities depending on the patient's ability), and an environmental protocol (lights off at night and on during the day, ear plugs, noise reduction during the night). In addition to non-pharmacological delirium prevention and management, this list will have a checkbox indicating if the family caregiver notified any member of the bedside care team about symptoms of delirium.
Family members in both intervention and control groups will also complete follow-up questionnaires at 1-month and 3-months through an online link to a REDCap survey. These questionnaires will include the Family Satisfaction for the Intensive Care Unit (FSICU), KPDS-10, GAD-7, PHQ-9, and CIDKQ .
- Conditions
- Delirium, Intensive Care Unit Delirium, Post Intensive Care Unit Syndrome, Post Intensive Care Unit Syndrome Family
- Being tested
- Delirium Education, Prevention, and Management, Standard Care
- Keywords
- delirium, intensive care unit, critically ill, delirium detection, delirium prevention, delirium education, delirium management, psychological distress, post intensive care syndrome, post intensive care syndrome family
- Medical subject headings
- Delirium, Critical Illness, postintensive care syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Delirium Education, Prevention, and ManagementBehavioural
Patients and families will have a choice of either watching a 6-minute video or reading an educational booklet with a competent research assistant on the signs of delirium, risk factors, and prevention and management strategies.
Caregivers will practice identifying delirium with the Sour Seven questionnaire, using previously validated case vignettes of hypothetical ICU patients. Family members will also complete a daily checklist of non-pharmacological interventions (ie. orientation, mobility, and environmental cues).
Delirium detection by family caregivers will be assessed by the Sour Seven Questionnaire and communicated to the bedside nurse.
Standard CareBehavioural
Patients and families will receive standard care, which is an informational pamphlet on ICU delirium upon admission.
| Study group | Role | What they receive |
|---|---|---|
| Control Group | Placebo comparator | Patients and families will receive standard care, which is an informational pamphlet on ICU delirium upon admission. The intervention group will also receive the same pamphlet. Receives: Behavioral: Standard Care |
| Intervention Group | Experimental | Patients and families will receive standard care, which is an informational pamphlet on ICU delirium upon admission. Additionally, they will receive delirium education on prevention and management of delirium. Receives: Behavioral: Delirium Education, Prevention, and Management; Behavioral: Standard Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in proportion of major depressive disorder symptomatology in family members of critically ill patients measured by Patient Health Questionnaire-9 (PHQ-9) compared between control and intervention.
9-item questionnaire administered to caregivers to determine depression severity:
0-4 none, 5-9 mild, 10-14 moderate, 15-19 moderately severe, 20-27 severe
Measured: Up to 5 days
Change in proportion of major depressive disorder symptomatology in family members of critically ill patients measured by Patient Health Questionnaire-9 (PHQ-9) compared between control and intervention.
9-item questionnaire administered to caregivers to determine depression severity:
0-4 none, 5-9 mild, 10-14 moderate, 15-19 moderately severe, 20-27 severe
Measured: At 1-month follow-up post patient ICU discharge
Change in proportion of major depressive disorder symptomatology in family members of critically ill patients measured by Patient Health Questionnaire-9 (PHQ-9) compared between control and intervention.
9-item questionnaire administered to caregivers to determine depression severity:
0-4 none, 5-9 mild, 10-14 moderate, 15-19 moderately severe, 20-27 severe
Measured: At 3-month follow-up post patient ICU discharge
Change in proportion of generalized anxiety symptomatology in family members of critically ill patients measured by Generalized Anxiety Disorder-7 (GAD-7) compared between control and intervention.
A 7-item questionnaire administered to caregivers with scores ranging from 0-21. Scores indicate anxiety severity: 0-4 (minimal anxiety), 5-9 (mild anxiety), 10-14 (moderate anxiety), and 15-21 (severe anxiety)
Measured: Up to 5 days
Change in proportion of generalized anxiety symptomatology in family members of critically ill patients measured by Generalized Anxiety Disorder-7 (GAD-7) compared between control and intervention.
A 7-item questionnaire administered to caregivers with scores ranging from 0-21. Scores indicate anxiety severity: 0-4 (minimal anxiety), 5-9 (mild anxiety), 10-14 (moderate anxiety), and 15-21 (severe anxiety)
Measured: At 1-month follow-up post patient ICU discharge
Change in proportion of generalized anxiety symptomatology in family members of critically ill patients measured by Generalized Anxiety Disorder-7 (GAD-7) compared between control and intervention.
A 7-item questionnaire administered to caregivers with scores ranging from 0-21. Scores indicate anxiety severity: 0-4 (minimal anxiety), 5-9 (mild anxiety), 10-14 (moderate anxiety), and 15-21 (severe anxiety)
Measured: At 3-month follow-up post patient ICU discharge
Secondary outcomes (7)
The change in prevalence of delirium in critically ill patients measured by the Intensive Care Delirium Screening Checklist (ICDSC) pre- and post-intervention
ICDSC is an 8-item checklist to be administered by a clinician. Scores range from 0-8. Patients with scores equal to greater than 4 require clinical assessment for a delirium diagnosis.
Measured: Immediately before and after intervention
The duration of delirium in critically ill patients measured by the mean days with delirium as determined by the ICDSC
ICDSC is an 8-item checklist to be administered by a clinician. Scores range from 0-8. Patients with scores equal to greater than 4 require clinical assessment for a delirium diagnosis.
Measured: Through ICU stay, an average of 2 weeks
The change in the severity of delirium in critically ill patients measured by the most severe ICDSC scores pre- and post-intervention.
ICDSC is an 8-item checklist to be administered by a clinician. Scores range from 0-8. Patients with scores equal to greater than 4 require clinical assessment for a delirium diagnosis.
Measured: Throughout ICU stay, an average of 2 weeks
Identification of patient delirium in the medical charts
Evaluated through retrospective review of medical charts
Measured: Through study completion, an average of 1 year
The change in delirium knowledge in family members of critically ill patients measured by Caregiver ICU Delirium Knowledge Questionnaire (CIDKQ) pre- and post-intervention
21-item multiple choice questionnaire on delirium risk factors, actions (prevention and management), and symptoms. The scores range from 0-21. Higher scores indicate higher level of delirium knowledge.
Measured: Immediately pre- and post- intervention (within the day of intervention), at 1- and 3-month follow-up post ICU discharge.
Burden of delirium experienced by family members of critically ill patients measured by Caregiver Delirium Burden Instrument (DEL-B)
The DEL-B is an 8-item questionnaire administered to caregivers. Scores range from 0-40. Higher scores indicate higher burden.
Measured: Up to 5 days
Psychological distress in family members of critically ill patients measured by Kessler Psychological Distress Scale (KPDS-10)
10-item questionnaire administered to caregivers with the likelihood of having a mental disorder: likely to be well (scores between 10-19), likely to have a mild disorder (20-24), moderate disorder (25-29), or severe disorder (30-50).
Measured: Up to 5 days, and at 1-month and 3-month follow-up post patient ICU discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2019
- Study start13 Jan 2020
- Primary completion31 Jan 2024
- Study completion31 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- 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
- Parallel groups
- Model description
- All consecutively enrolled dyads (patient and caregiver) will be randomly assigned to either the control or intervention group. Both groups will receive standard care. The intervention group will receive additional ICU delirium education.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 128 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Calgary
- Sponsor type
- University, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR)
- Responsible party
- Principal investigator, Kirsten Fiest, University of Calgary
- Investigators
- Kirsten Fiest, PhD, Principal investigator, University of Calgary
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04099472
- Sponsor's protocol ID
- REB19-1000
- Other IDs
- 423947, 10020187
- Status last verified
- Jan 2025
- First submitted
- 17 Sep 2019
- Last updated
- 28 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Fiest KM, Krewulak KD, Sept BG, Davidson JE, Ely EW, Lee CH, Soo A, Stelfox HT. A Pilot Randomized Controlled Trial Assessing the Feasibility and Acceptability of Family-Partnered Delirium Prevention, Detection, and Management in Critically Ill Adults: The Activating Family Caregivers in the Identification Prevention and Management of Delirium (ACTIVATE) Study. Crit Care Explor. 2025 Aug 22;7(9):e1287. doi: 10.1097/CCE.0000000000001287. eCollection 2025 Sep 1.
PubMed 40844707Fiest KM, Krewulak KD, Sept BG, Spence KL, Davidson JE, Ely EW, Soo A, Stelfox HT. A study protocol for a randomized controlled trial of family-partnered delirium prevention, detection, and management in critically ill adults: the ACTIVATE study. BMC Health Serv Res. 2020 May 24;20(1):453. doi: 10.1186/s12913-020-05281-8.
PubMed 32448187
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Family-administered Delirium Prevention, Detection, and Management in the Critically Ill: a Randomized Control Trial
- ClinicalTrials.gov ID
- NCT04099472
- Acronym / sponsor ID
- REB19-1000
- 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
- Completed
- Enrolment
- 128 participants (actual)
- Lead sponsor
- University of CalgaryUniversity, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR)
- Study start
- 13 Jan 2020 (actual)
- Primary completion
- 31 Jan 2024 (actual)
- Study completion
- 31 Jan 2024 (actual)
- First posted
- 23 Sep 2019 (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 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 to identify delirium, and how to prevent and manage delirium using non-pharmacological strategies.
Family delirium detection may result in earlier and more accurate recognition of delirium and meaningful family involvement, and therein the potential for better patient and family outcomes. We aim to determine the efficacy of employing family-administered delirium prevention, detection, and management in the critically ill, compared to usual 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 will be a parallel-group randomized control trial with a 1:1 allocation ratio. Consecutive, eligible patients admitted to 4 ICUs in Calgary, Alberta, Canada with at least one family member present will be identified by discussion with the most responsible attending physician and bedside nurse. All eligible and consenting family members will receive standard care, which is an informational pamphlet on ICU delirium presented to all patients and families upon admission. Participants in both the intervention and control groups will also complete a demographics questionnaire, the Critical Care Family Needs Inventory (CCFNI), the Barriers to Care Questionnaire in the ICU (BCQ-ICU), the Caregiver Coping Strategies (CSS) questionnaire, and the Caregiver ICU Delirium Knowledge Questionnaire (CIDKQ) upon enrollment. Additionally, all family members will complete the Delirium Burden (DEL-B) questionnaire, Kessler Psychological Distress Scale (KPDS-10), Patient Health Questionnaire 9 (PHQ-9), Generalized Anxiety Disorder 7 (GAD-7) daily for a maximum of five days.
Family members randomized to the intervention group will receive additional ICU delirium education, whereas the control group will not. The intervention includes components of delirium education, prevention/management and detection. Family members will receive education by watching a 6-minute education video or reading an education booklet with a trained research assistant on the signs of delirium, who is at risk, and what they can do to prevent and manage it. They will practice identifying delirium with the Sour Seven questionnaire using previously validated case vignettes of hypothetical ICU patients. Delirium prevention and management will include a daily checklist of non-pharmacological interventions to be completed by the family member. This will include an orientation protocol (e.g., provide visual and hearing aids, orientation of day/time/location, familiar objects from home, television during the day with daily news, non-verbal music), mobility protocol (cognitive activities depending on the patient's ability), and an environmental protocol (lights off at night and on during the day, ear plugs, noise reduction during the night). In addition to non-pharmacological delirium prevention and management, this list will have a checkbox indicating if the family caregiver notified any member of the bedside care team about symptoms of delirium.
Family members in both intervention and control groups will also complete follow-up questionnaires at 1-month and 3-months through an online link to a REDCap survey. These questionnaires will include the Family Satisfaction for the Intensive Care Unit (FSICU), KPDS-10, GAD-7, PHQ-9, and CIDKQ .
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- All consecutively enrolled dyads (patient and caregiver) will be randomly assigned to either the control or intervention group. Both groups will receive standard care. The intervention group will receive additional ICU delirium education.
| Arm | Type | Receives |
|---|---|---|
| Control Group | Placebo comparator | Behavioral: Standard CarePatients and families will receive standard care, which is an informational pamphlet on ICU delirium upon admission. The intervention group will also receive the same pamphlet. |
| Intervention Group | Experimental | Behavioral: Delirium Education, Prevention, and Management, Behavioral: Standard CarePatients and families will receive standard care, which is an informational pamphlet on ICU delirium upon admission. Additionally, they will receive delirium education on prevention and management of delirium. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Intensive care unit (ICU) patients aged 18+ anticipated to remain admitted in the ICU for at least a further 24 hours to complete the intervention and all assessments at least once
- ICU patient has a caregiver (i.e., family member or friend) present
- Richmond Agitation Sedation Scale (RASS) ≥-3
- The ability to provide informed consent (both patient and family member; surrogate consent possible)
- The ability to communicate with research staff (fluent in English, no hearing or visual impairment that precludes communication)
Key exclusion criteria (1 listed)
- Primary direct brain injury (e.g., traumatic brain injury, subarachnoid hemorrhage) with a Glasgow Coma Scale score of <9
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 |
|---|---|---|
| Delirium Education, Prevention, and ManagementPatients and families will have a choice of either watching a 6-minute video or reading an educational booklet with a competent research assistant on the signs of delirium, risk factors, and prevention and management strategies. Caregivers will practice identifying delirium with the Sour Seven questionnaire, using previously validated case vignettes of hypothetical ICU patients. Family members will also complete a daily checklist of non-pharmacological interventions (ie. orientation, mobility, and environmental cues). Delirium detection by family caregivers will be assessed by the Sour Seven Questionnaire and communicated to the bedside nurse. | Behavioural | Intervention Group |
| Standard CarePatients and families will receive standard care, which is an informational pamphlet on ICU delirium upon admission. | Behavioural | Control Group, Intervention Group |
Primary outcome
Change in proportion of major depressive disorder symptomatology in family members of critically ill patients measured by Patient Health Questionnaire-9 (PHQ-9) compared between control and intervention.
Time frame: Up to 5 days
9-item questionnaire administered to caregivers to determine depression severity: 0-4 none, 5-9 mild, 10-14 moderate, 15-19 moderately severe, 20-27 severe
Change in proportion of major depressive disorder symptomatology in family members of critically ill patients measured by Patient Health Questionnaire-9 (PHQ-9) compared between control and intervention.
Time frame: At 1-month follow-up post patient ICU discharge
9-item questionnaire administered to caregivers to determine depression severity: 0-4 none, 5-9 mild, 10-14 moderate, 15-19 moderately severe, 20-27 severe
Change in proportion of major depressive disorder symptomatology in family members of critically ill patients measured by Patient Health Questionnaire-9 (PHQ-9) compared between control and intervention.
Time frame: At 3-month follow-up post patient ICU discharge
9-item questionnaire administered to caregivers to determine depression severity: 0-4 none, 5-9 mild, 10-14 moderate, 15-19 moderately severe, 20-27 severe
Change in proportion of generalized anxiety symptomatology in family members of critically ill patients measured by Generalized Anxiety Disorder-7 (GAD-7) compared between control and intervention.
Time frame: Up to 5 days
A 7-item questionnaire administered to caregivers with scores ranging from 0-21. Scores indicate anxiety severity: 0-4 (minimal anxiety), 5-9 (mild anxiety), 10-14 (moderate anxiety), and 15-21 (severe anxiety)
Change in proportion of generalized anxiety symptomatology in family members of critically ill patients measured by Generalized Anxiety Disorder-7 (GAD-7) compared between control and intervention.
Time frame: At 1-month follow-up post patient ICU discharge
A 7-item questionnaire administered to caregivers with scores ranging from 0-21. Scores indicate anxiety severity: 0-4 (minimal anxiety), 5-9 (mild anxiety), 10-14 (moderate anxiety), and 15-21 (severe anxiety)
Change in proportion of generalized anxiety symptomatology in family members of critically ill patients measured by Generalized Anxiety Disorder-7 (GAD-7) compared between control and intervention.
Time frame: At 3-month follow-up post patient ICU discharge
A 7-item questionnaire administered to caregivers with scores ranging from 0-21. Scores indicate anxiety severity: 0-4 (minimal anxiety), 5-9 (mild anxiety), 10-14 (moderate anxiety), and 15-21 (severe anxiety)
7 secondary outcomes
The change in prevalence of delirium in critically ill patients measured by the Intensive Care Delirium Screening Checklist (ICDSC) pre- and post-intervention
Time frame: Immediately before and after intervention
The duration of delirium in critically ill patients measured by the mean days with delirium as determined by the ICDSC
Time frame: Through ICU stay, an average of 2 weeks
The change in the severity of delirium in critically ill patients measured by the most severe ICDSC scores pre- and post-intervention.
Time frame: Throughout ICU stay, an average of 2 weeks
Identification of patient delirium in the medical charts
Time frame: Through study completion, an average of 1 year
The change in delirium knowledge in family members of critically ill patients measured by Caregiver ICU Delirium Knowledge Questionnaire (CIDKQ) pre- and post-intervention
Time frame: Immediately pre- and post- intervention (within the day of intervention), at 1- and 3-month follow-up post ICU discharge.
Burden of delirium experienced by family members of critically ill patients measured by Caregiver Delirium Burden Instrument (DEL-B)
Time frame: Up to 5 days
Psychological distress in family members of critically ill patients measured by Kessler Psychological Distress Scale (KPDS-10)
Time frame: Up to 5 days, and at 1-month and 3-month follow-up post patient ICU discharge
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 28 Jan 2025.
- Derived from this study: PubMed 40844707Fiest KM, Krewulak KD, Sept BG, Davidson JE, Ely EW, Lee CH, Soo A, Stelfox HT. A Pilot Randomized Controlled Trial Assessing the Feasibility and Acceptability of Family-Partnered Delirium Prevention, Detection, and Management in Critically Ill Adults: The Activating Family Caregivers in the Identification Prevention and Management of Delirium (ACTIVATE) Study. Crit Care Explor. 2025 Aug 22;7(9):e1287. doi: 10.1097/CCE.0000000000001287. eCollection 2025 Sep 1.
- Derived from this study: PubMed 32448187Fiest KM, Krewulak KD, Sept BG, Spence KL, Davidson JE, Ely EW, Soo A, Stelfox HT. A study protocol for a randomized controlled trial of family-partnered delirium prevention, detection, and management in critically ill adults: the ACTIVATE study. BMC Health Serv Res. 2020 May 24;20(1):453. doi: 10.1186/s12913-020-05281-8.
- 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.
Kirsten Fiest, PhD principal investigator
University of Calgary
4 sites 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 4 sites 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 1 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 28 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites 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?
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?
Change in proportion of major depressive disorder symptomatology in family members of critically ill patients measured by Patient Health Questionnaire-9 (PHQ-9) compared between control and intervention. (time frame: Up to 5 days). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04099472, which also lists 2 linked publications.
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 28 Jan 2025.