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ClinicalTrials.gov ID

NCT06984770

Lead Sponsor

Lady Davis InstituteOTHER

Overall Status

Not yet recruiting

Study Type

Interventional

Phase

Not Applicable

Enrollment

60Estimated

Last Update Posted

May 22, 2025Actual

Start Date

Aug 2025Estimated

Primary Completion Date

Jan 2027Estimated

Completion Date

Aug 2027Estimated

Official Title

Caring for the Caregiver: A Pilot Randomized Controlled Trial (The Family Cares Trial)

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.

• Family Engagement
• Critical Care, Intensive Care
• Patient and Family Engagement
• Health Care Delivery
• Family-centered Care
• Pilot Study
• Caregiver
• Caregiver Burden
• Family Caregivers

• Virtual peer support group intervention
• Caregiver Support intervention
• Resources

Ages Eligible for Study

Adult (18-64)Older Adult (65+)

Sexes Eligible for Study

All

Accepts Healthy Volunteers

Yes

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 Purpose

Health Services Research

Allocation

Randomized

Interventional Model

Parallel Assignment

Masking

Double

Lead Sponsor

Lady Davis InstituteOTHER

jillian.kifell.ccomtl@ssss.gouv.qc.ca5143408222 ext. 25806