The Family Cares Trial

NCT ID: NCT06984770

Last Updated: 2025-05-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-08-31

Study Completion Date

2027-08-31

Brief Summary

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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.

Detailed Description

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Conditions

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Study Groups

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Control Group: Resources only

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

Group Type ACTIVE_COMPARATOR

Resources

Intervention Type OTHER

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

Intervention Group

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'.

Group Type EXPERIMENTAL

Virtual peer support group intervention

Intervention Type 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.

Caregiver Support intervention

Intervention Type BEHAVIORAL

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

Resources

Intervention Type OTHER

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

Interventions

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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.

Intervention Type 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.

Intervention Type BEHAVIORAL

Resources

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

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Lady Davis Institute

OTHER

Sponsor Role lead

Responsible Party

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Michael Goldfarb

Attending Staff, Division of Cardiology

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Michael J Goldfarb, MD, MSc

Role: PRINCIPAL_INVESTIGATOR

Lady Davis Institute, McGill University, Jewish General Hospital

Locations

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Jewish General Hospital

Montreal, Quebec, Canada

Site Status

McGill University Health Centre

Montreal, Quebec, Canada

Site Status

Countries

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Canada

Central Contacts

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Jillian Kifell, MSc

Role: CONTACT

5143408222 ext. 25806

Facility Contacts

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Jillian Kifell, MSc

Role: primary

5143408222 ext. 25806

Jillian Kifell, MSc

Role: primary

5143408222 ext. 25806

Other Identifiers

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MP-05-2026-4603

Identifier Type: -

Identifier Source: org_study_id

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