The Family Cares Trial

Lady Davis Institute

Status: Not yet enrolling

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

Treatments: Behavioral: Caregiver Support intervention; Other: Resources; Behavioral: Virtual peer support group intervention

Study type: Interventional

Funder types: Other

Identifiers

NCT06984770

MP-05-2026-4603

Details and patient eligibility

About

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.

Enrollment: 60 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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60 participants in 2 patient groups

Control Group: Resources only

Active Comparator group

Description:

Participants will be given a list of resources for emotional or psychological distress.

Treatment:

Other: Resources

Intervention Group

Experimental group

Description:

Participants assigned to the intervention group will be permitted to choose which strategy they wish to participate in. This innovative person-centered approach will ensure that family caregivers get the type of support that they want and are not arbitrarily assigned to a strategy that they are not motivated to pursue, resulting in a pragmatic, real-world approach to choice of strategy. Participants will have the choice of two strategies: 'Virtual peer support group' or 'Caregiver Support'.

Treatment:

Behavioral: Virtual peer support group intervention

Other: Resources

Behavioral: Caregiver Support intervention