Clinical trial NCT06984770: The Family Cares Trial
Official title: Caring for the Caregiver: A Pilot Randomized Controlled Trial (The Family Cares Trial)
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Family Engagement
Critical Care, Intensive Care
Patient and Family Engagement
Health Care Delivery
Family-centered Care
Pilot Study
Caregiver
Caregiver Burden
Family Caregivers
Keywords: Patient- and Family-Centered Care
Family Engagement
Critical Care
Intensive Care Unit
Person-Centered Care
Delivery of Health Care
Post-ICU
Caregivers
Family Caregiver
Lead sponsor: Lady Davis Institute
Sponsor class: OTHER
First posted: 2025-05-22
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The goal of this pilot study is to learn if virtual peer support groups and strengths-based skills training can help family caregivers of ICU survivors providing ongoing support to ICU survivors after hospital discharge. The main question it aims to answer is:

- Are virtual peer support groups and/or strengths-based skills support feasible and acceptable for family caregivers of ICU survivors? Researchers will compare the intervention group (virtual peer support groups or strengths-based skills training) to the control group (no intervention) to see if the interventions improve caregiver outcomes and assess feasibility and acceptability.

Participants will:

* Participate in either virtual peer support groups or strengths-based skills training sessions (if assigned to the intervention arm).
* Provide feedback on the feasibility and acceptability of the interventions (if assigned to the intervention arm).
* Complete surveys and follow-up questionnaires (either online or by phone) to measure outcomes.


Eligibility criteria: Inclusion Criteria:

* (1) Family member of a person admitted to an ICU for \>48 hours and survived to hospital discharge. "Family" is anyone with a biological, legal, or emotional relationship with the patient and whom the patient wants involved in their care
* (2) Planned or current part or full-time caregiver of the ICU survivor
* (3) Age ≥ 18 years
* (4) Within 6 months of ICU survivor's hospital discharge.

Exclusion Criteria:

* (1) Another family member participating in the study
* (2) Inability to communicate in English or French.

Primary outcomes:
measure: Caregiver Burden - The Zarit Burden Interview-12 (ZBI-12) - 3 months
timeFrame: 3 months post-enrollment or post intervention initiation
Secondary outcomes:
measure: Caregiver Burden - The Zarit Burden Interview-12 (ZBI-12) - 6 months
timeFrame: 6 months post-enrollment or post intervention initiation
measure: Multidimensional Scale of Perceived Social Support (MSPSS) - 3 months
timeFrame: 3 months post-enrollment or post intervention initiation
measure: Multidimensional Scale of Perceived Social Support (MSPSS) - 6 months
timeFrame: 6 months post-enrollment or post intervention initiation
measure: Patient Health Questionnaire-9 (PHQ-9) - 3 months
timeFrame: 3 months post-enrollment or post intervention initiation
measure: Patient Health Questionnaire-9 (PHQ-9) - 6 months
timeFrame: 6 months post-enrollment or post intervention initiation
measure: Post-traumatic stress (IES-Revised) - 3 months
timeFrame: 3 months post-enrollment or post intervention initiation
measure: Post-traumatic stress (IES-Revised) - 6 months
timeFrame: 6 months post-enrollment or post intervention initiation
measure: Insomnia Severity Index (ISI) - 3 months
timeFrame: 3 months post-enrollment or post intervention initiation
measure: Insomnia Severity Index (ISI) - 6 months
timeFrame: 6 months post-enrollment or post intervention initiation
measure: Quality of life (EuroQOL-5D-5L score) - 3 months
timeFrame: 3 months post-enrollment or post intervention initiation
measure: Quality of life (EuroQOL-5D-5L score) - 6 months
timeFrame: 6 months post-enrollment or post intervention initiation
measure: Connor-Davidson Resilience Scale-10 (CD-RISC 10) - 3 months
timeFrame: 3 months post-enrollment or post intervention initiation
measure: Connor-Davidson Resilience Scale-10 (CD-RISC 10) - 6 months
timeFrame: 6 months post-enrollment or post intervention initiation
Other outcomes:
measure: FAM-Activate (FAM-A)
timeFrame: completed at enrolment in the study
measure: FAMily Engagement (FAME)
timeFrame: completed at enrolment in the study
Locations:
city: Montreal
country: Canada
facility: Jewish General Hospital
state: Quebec
city: Montreal
country: Canada
facility: McGill University Health Centre
state: Quebec
Study officials:
affiliation: Lady Davis Institute, McGill University, Jewish General Hospital
name: Michael J Goldfarb, MD, MSc
role: PRINCIPAL_INVESTIGATOR
References: