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Measuring Family Engagement in Care (The FAME Study)

Study acronym: FAME
StatusRecruiting
PhaseNot specified
Started2023-01-31
View on ClinicalTrials.gov ↗
Record status
This record was last updated February 13, 2025 (before its estimated December 2025 completion). Its status may not reflect the trial's current state.

Amendment history

2025-02-11
notable
Active, Not Recruiting→Recruiting Study Status, Contacts/Locations v6
Trial statusActive, Not Recruiting→Recruiting
Study sites4→6
2025-02-06
notable
Recruiting→Active, Not Recruiting Study Status, Contacts/Locations v5
Trial statusRecruiting→Active, Not Recruiting
Study sitesdetails revised at 4 of 4 sites
2024-12-18
minor
Study Status, Sponsor/Collaborators, Contacts/Locations v4
Primary completion date2024-12→2025-12
Completion date2024-12-30→2025-12-30
Study sitesdetails revised at 4 of 4 sites
Collaborators1 to 2 entries
Canadian Institutes of Health Research (CIHR)
2024-09-04
minor
Study Status, Oversight, Eligibility, Contacts/Locations v3
Primary completion date2024-08-30→2024-12
Study sitescontacts updated at 1 of 4 sites
2024-04-15
minor
Study Status v2
Primary completion date2024-03-30→2024-08-30
Completion date2024-03-30→2024-12-30
2023-03-08
notable
Not Yet Recruiting→Recruiting Study Status, Contacts/Locations v1
Trial statusNot Yet Recruiting→Recruiting
Start dateestimated 2023-01-02→confirmed 2023-01-31
Study sitesdetails revised at 4 of 4 sites
2022-12-12
minor
Original filing
There are currently no validated tools to specifically measure family engagement in the intensive care unit (ICU). To address this gap, an interdisciplinary team developed a novel instrument to measure family engagement in the ICU. This will be a prospective observational cohort with an embedded qualitative study to validate the FAMily Engagement (FAME) instrument in the ICU setting. This study will also evaluate the association between family activation, engagement, and family-centred outcomes, and exploring factors (age, relationship, sex, gender, race/ethnicity) that may influence family engagement in the ICU.
Trial Details
NCT Number NCT05659485
Lead Sponsor Lady Davis Institute
Collaborators: Jewish General Hospital, Canadian Institutes of Health Research (CIHR)
Conditions Family Engagement, Patient-centered Care, Critical Care
Enrollment 198 participants
Start Date 2023-01-31
Primary Completion 2025-12 (estimated)
Study Completion 2025-12-30 (estimated)
Updated on ClinicalTrials.gov 2025-02-13