The Family Cares Trial

NCT06984770 | Not Yet Recruiting

• 1 other identifier: MP-05-2026-4603
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 2

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.

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

Outcome Measures

Primary Outcomes (1)

• Caregiver Burden - The Zarit Burden Interview-12 (ZBI-12) - 3 months

  A 12-item self-report tool that has been validated for measuring the level of caregiver burden related to care provision. Each item in the ZBI-12 is scored on a five-point Likert scale from 0 to 4 (0=never to 4=nearly always). Summed scores range from 0-48, with greater scores representing greater feelings of burden.

  3 months post-enrollment or post intervention initiation

Secondary Outcomes (13)

• Caregiver Burden - The Zarit Burden Interview-12 (ZBI-12) - 6 months

  6 months post-enrollment or post intervention initiation

• Multidimensional Scale of Perceived Social Support (MSPSS) - 3 months

  3 months post-enrollment or post intervention initiation

• Multidimensional Scale of Perceived Social Support (MSPSS) - 6 months

  6 months post-enrollment or post intervention initiation

• Patient Health Questionnaire-9 (PHQ-9) - 3 months

  3 months post-enrollment or post intervention initiation

• Patient Health Questionnaire-9 (PHQ-9) - 6 months

  6 months post-enrollment or post intervention initiation

Other Outcomes (2)

• FAM-Activate (FAM-A)

  completed at enrolment in the study

• FAMily Engagement (FAME)

  completed at enrolment in the study

Study Arms (2)

Control Group: Resources only

ACTIVE COMPARATOR

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

Other: Resources

Intervention Group

EXPERIMENTAL

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'.

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

Interventions

Virtual peer support group intervention BEHAVIORAL

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.

Intervention Group

Caregiver Support intervention BEHAVIORAL

The caregiver support intervention is a personalized program designed to improve quality of life, reduce fatigue and caregiver burden, and build resilience.

Intervention Group

Resources OTHER

Participants will be given a list of resources to contact in case of emotional or psychological distress.

Control Group: Resources only; Intervention Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• (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.

You may not qualify if:

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

Sponsors & Collaborators

• Lady Davis Institute: lead

Study Sites (2)

Jewish General Hospital

Montreal, Quebec, Canada

Location

McGill University Health Centre

Montreal, Quebec, Canada

Location

MeSH Terms

Conditions

Caregiver Burden

Interventions

Health Resources

Condition Hierarchy (Ancestors)

Stress, Psychological; Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Health Planning; Health Care Economics and Organizations; Delivery of Health Care; Health Care Quality, Access, and Evaluation

Study Officials

• Michael J Goldfarb, MD, MSc

  Lady Davis Institute, McGill University, Jewish General Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jillian Kifell, MSc

CONTACT

5143408222; jillian.kifell.ccomtl@ssss.gouv.qc.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Attending Staff, Division of Cardiology

Study Record Dates

• First Submitted: May 14, 2025
• First Posted: May 22, 2025
• Study Start: August 1, 2025
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): August 1, 2027
• Last Updated: May 22, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

CA (2)