The Family Cares Trial
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Virtual peer support group intervention, Caregiver Support intervention, Resources.
- Who it may be relevant to
- Registry conditions: Family Engagement, Critical Care, Intensive Care, Patient and Family Engagement, Health Care Delivery. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Canada
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Caring for the Caregiver: A Pilot Randomized Controlled Trial (The Family Cares Trial)
Overview
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.
Interventions
- Behavioral Virtual peer support group intervention
The virtual peer support group aims to improve emotional well-being, reduce isolation, and help caregivers cope by offering a safe space to share experiences and receive support from others facing similar caregiving demands. - Behavioral Caregiver Support intervention
The caregiver support intervention is a personalized program designed to improve quality of life, reduce fatigue and caregiver burden, and build resilience. - Other Resources
Participants will be given a list of resources to contact in case of emotional or psychological distress.
Primary outcome measures
- Caregiver Burden - The Zarit Burden Interview-12 (ZBI-12) - 3 months [Time frame: 3 months post-enrollment or post intervention initiation]
Secondary outcome measures (12)
- Caregiver Burden - The Zarit Burden Interview-12 (ZBI-12) - 6 months [Time frame: 6 months post-enrollment or post intervention initiation]
- Multidimensional Scale of Perceived Social Support (MSPSS) - 3 months [Time frame: 3 months post-enrollment or post intervention initiation]
- Multidimensional Scale of Perceived Social Support (MSPSS) - 6 months [Time frame: 6 months post-enrollment or post intervention initiation]
- Patient Health Questionnaire-9 (PHQ-9) - 3 months [Time frame: 3 months post-enrollment or post intervention initiation]
- Patient Health Questionnaire-9 (PHQ-9) - 6 months [Time frame: 6 months post-enrollment or post intervention initiation]
- Post-traumatic stress (IES-Revised) - 3 months [Time frame: 3 months post-enrollment or post intervention initiation]
- Post-traumatic stress (IES-Revised) - 6 months [Time frame: 6 months post-enrollment or post intervention initiation]
- Insomnia Severity Index (ISI) - 3 months [Time frame: 3 months post-enrollment or post intervention initiation]
- Insomnia Severity Index (ISI) - 6 months [Time frame: 6 months post-enrollment or post intervention initiation]
- Quality of life (EuroQOL-5D-5L score) - 3 months [Time frame: 3 months post-enrollment or post intervention initiation]
- Quality of life (EuroQOL-5D-5L score) - 6 months [Time frame: 6 months post-enrollment or post intervention initiation]
- Connor-Davidson Resilience Scale-10 (CD-RISC 10) - 3 months [Time frame: 3 months post-enrollment or post intervention initiation]
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Health services research
Study locations
Canada · 2 centers
- Jewish General Hospital — Montreal
- McGill University Health Centre — Montreal
Identifiers
NCT: NCT06984770 · MP-05-2026-4603