Family EngagementFamily CaresNCT06984770
The Family Cares Trial
A study testing Virtual peer support group intervention, Caregiver Support intervention and Resources in people with Family Engagement and Critical Care, Intensive Care, run by Lady Davis Institute at 2 sites in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Family Engagement, Critical Care, Intensive Care, Patient and Family Engagement
- What is being tested?
- Virtual peer support group intervention, Caregiver Support intervention and Resources
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 2 sitesCanada
- Study dates
- Aug 2025to Aug 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- (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.
Who cannot join
- (1) Another family member participating in the study
- (2) Inability to communicate in English or French.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Canada2 sites
Jewish General Hospital
Montreal, Quebec
Jillian Kifell, MSc, 5143408222 ext. 25806, jillian.kifell.ccomtl@ssss.gouv.qc.ca
Michael J Goldfarb, MD, MSc
McGill University Health Centre
Montreal, Quebec
Jillian Kifell, MSc, 5143408222 ext. 25806, jillian.kifell.ccomtl@ssss.gouv.qc.ca
Michael J Goldfarb, MD, MSc
About this study
Official title: Caring for the Caregiver: A Pilot Randomized Controlled Trial (The Family Cares Trial)
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.
Read more
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
- Being tested
- Virtual peer support group intervention, Caregiver Support intervention, Resources
- 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
- Medical subject headings
- Caregiver Burden
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual peer support group interventionBehavioural
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 interventionBehavioural
The caregiver support intervention is a personalized program designed to improve quality of life, reduce fatigue and caregiver burden, and build resilience.
ResourcesOther
Participants will be given a list of resources to contact in case of emotional or psychological distress.
| Study group | Role | What they receive |
|---|---|---|
| Control Group: Resources only | Active comparator | Participants will be given a list of resources for emotional or psychological distress. Receives: 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'. Receives: Behavioral: Virtual peer support group intervention; Behavioral: Caregiver Support intervention; Other: Resources |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3 months post-enrollment or post intervention initiation
Secondary outcomes (13)
Caregiver Burden - The Zarit Burden Interview-12 (ZBI-12) - 6 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.
Measured: 6 months post-enrollment or post intervention initiation
Multidimensional Scale of Perceived Social Support (MSPSS) - 3 months
A 12-item self-report tool that has been validated for measuring perceived social support from family, friends and significant others. Each item is scored on a likert scale from 1-7, where 1= Very strongly disagree, and 7= very strongly agree. Total scores range from 12 to 84, where a score of 12-35 could be considered low support; a score of 33 to 60 could be considered moderate support; a score from 61 to 84 could be considered high support.
Measured: 3 months post-enrollment or post intervention initiation
Multidimensional Scale of Perceived Social Support (MSPSS) - 6 months
A 12-item self-report tool that has been validated for measuring perceived social support from family, friends and significant others. Each item is scored on a likert scale from 1-7, where 1= Very strongly disagree, and 7= very strongly agree. Total scores range from 12 to 84, where a score of 12-35 could be considered low support; a score of 33 to 60 could be considered moderate support; a score from 61 to 84 could be considered high support.
Measured: 6 months post-enrollment or post intervention initiation
Patient Health Questionnaire-9 (PHQ-9) - 3 months
A 9-item self-reported tool to quantify depression symptoms and monitor severity. Each item is scored using a 4-point Likert scale ranging from 0-3 (not at all=0, several days=1, more than half the days=2, and nearly every day=3). The total score can range from 0 to 27, where a total score of 0-4 indicates minimal to no depression, 5-9 indicates mild depression, 10-14 indicates moderate depression, 15-19 indicates moderately severe depression, and 20-27 indicates severe depression.
Measured: 3 months post-enrollment or post intervention initiation
Patient Health Questionnaire-9 (PHQ-9) - 6 months
A 9-item self-reported tool to quantify depression symptoms and monitor severity. Each item is scored using a 4-point Likert scale ranging from 0-3 (not at all=0, several days=1, more than half the days=2, and nearly every day=3). The total score can range from 0 to 27, where a total score of 0-4 indicates minimal to no depression, 5-9 indicates mild depression, 10-14 indicates moderate depression, 15-19 indicates moderately severe depression, and 20-27 indicates severe depression.
Measured: 6 months post-enrollment or post intervention initiation
Post-traumatic stress (IES-Revised) - 3 months
The IES-Revised is a 22-item questionnaire that has been validated and is widely used for measuring post-traumatic stress symptoms and yields a total score ranging from 0 to 88 and subscale scores for the Intrusion, Avoidance, and Hyperarousal subscales. Items are rated on a 5-point scale ranging from 0 (not at all) to 4 (extremely). High scores indicate greater severity of PTSD.
Measured: 3 months post-enrollment or post intervention initiation
Post-traumatic stress (IES-Revised) - 6 months
The IES-Revised is a 22-item questionnaire that has been validated and is widely used for measuring post-traumatic stress symptoms and yields a total score ranging from 0 to 88 and subscale scores for the Intrusion, Avoidance, and Hyperarousal subscales. Items are rated on a 5-point scale ranging from 0 (not at all) to 4 (extremely). High scores indicate greater severity of PTSD.
Measured: 6 months post-enrollment or post intervention initiation
Insomnia Severity Index (ISI) - 3 months
A 7-item self-report questionnaire that has been validated for measuring the nature, severity, and impact of insomnia. Responses on each item can range from 0 to 4, where higher scores indicate more acute symptoms of insomnia. Total score ranges from 0-28, and can be interpreted as follows: a total score of 0-7 indicates "no clinically significant insomnia," 8-14 indicates "subthreshold insomnia," 15-21 indicates "clinical insomnia (moderate severity)," and 22-28 indicates "clinical insomnia (severe).
Measured: 3 months post-enrollment or post intervention initiation
Insomnia Severity Index (ISI) - 6 months
A 7-item self-report questionnaire that has been validated for measuring the nature, severity, and impact of insomnia. Responses on each item can range from 0 to 4, where higher scores indicate more acute symptoms of insomnia. Total score ranges from 0-28, and can be interpreted as follows: a total score of 0-7 indicates "no clinically significant insomnia," 8-14 indicates "subthreshold insomnia," 15-21 indicates "clinical insomnia (moderate severity)," and 22-28 indicates "clinical insomnia (severe).
Measured: 6 months post-enrollment or post intervention initiation
Quality of life (EuroQOL-5D-5L score) - 3 months
The EuroQOL-5D-5L is a 5-item questionnaire that has been validated and is widely used for measuring health-related quality of life. Each dimension has five response levels: no problems (Level 1); slight; moderate; severe; and extreme problems (Level 5). The scores are combined to generate a single index value for overall health status. EQ-5D-5L index scores range from -0.59 to 1, where 1 is the best possible health state
Measured: 3 months post-enrollment or post intervention initiation
Quality of life (EuroQOL-5D-5L score) - 6 months
The EuroQOL-5D-5L is a 5-item questionnaire that has been validated and is widely used for measuring health-related quality of life. Each dimension has five response levels: no problems (Level 1); slight; moderate; severe; and extreme problems (Level 5). The scores are combined to generate a single index value for overall health status. EQ-5D-5L index scores range from -0.59 to 1, where 1 is the best possible health state
Measured: 6 months post-enrollment or post intervention initiation
Connor-Davidson Resilience Scale-10 (CD-RISC 10) - 3 months
A 10-item self-report tool that has been validated for measuring resilience. Each item is scored on a 5-point Likert scale (0 = "not true at all" to 4 = "true nearly all the time"). The total score ranges from 0 to 40, with higher scores indicating greater resilience.
Measured: 3 months post-enrollment or post intervention initiation
Connor-Davidson Resilience Scale-10 (CD-RISC 10) - 6 months
A 10-item self-report tool that has been validated for measuring resilience. Each item is scored on a 5-point Likert scale (0 = "not true at all" to 4 = "true nearly all the time"). The total score ranges from 0 to 40, with higher scores indicating greater resilience.
Measured: 6 months post-enrollment or post intervention initiation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2025
- Study startAug 2025 (estimated)
- Primary completionJan 2027 (estimated)
- Study completionAug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Family EngagementStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Lady Davis Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Michael Goldfarb, Lady Davis Institute
- Investigators
- Michael J Goldfarb, MD, MSc, Principal investigator, Lady Davis Institute, McGill University, Jewish General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06984770
- Sponsor's protocol ID
- MP-05-2026-4603
- Acronym
- Family Cares
- Status last verified
- May 2025
- First submitted
- 14 May 2025
- Last updated
- 22 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Caring for the Caregiver: A Pilot Randomized Controlled Trial (The Family Cares Trial)
- ClinicalTrials.gov ID
- NCT06984770
- Acronym / sponsor ID
- Family Cares / MP-05-2026-4603
- Conditions
- Family Engagement, Critical Care, Intensive Care, Patient and Family Engagement, Health Care Delivery, Family-centered Care, Pilot Study
- Keywords
- Patient- and Family-Centered Care, Family Engagement, Critical Care, Intensive Care Unit, Person-Centered Care, Delivery of Health Care, Post-ICU, Caregivers
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Lady Davis InstituteUniversity, hospital or other
- Study start
- Aug 2025 (estimated)
- Primary completion
- Jan 2027 (estimated)
- Study completion
- Aug 2027 (estimated)
- First posted
- 22 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control Group: Resources only | Active comparator | Other: ResourcesParticipants will be given a list of resources for emotional or psychological distress. |
| Intervention Group | Experimental | Behavioral: Virtual peer support group intervention, Behavioral: Caregiver Support intervention, Other: ResourcesParticipants 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'. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- (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.
Key exclusion criteria (2 listed)
- (1) Another family member participating in the study
- (2) Inability to communicate in English or French.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Virtual peer support group interventionThe 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. | Behavioural | Intervention Group |
| Caregiver Support interventionThe caregiver support intervention is a personalized program designed to improve quality of life, reduce fatigue and caregiver burden, and build resilience. | Behavioural | Intervention Group |
| ResourcesParticipants will be given a list of resources to contact in case of emotional or psychological distress. | Other | Control Group: Resources only, Intervention Group |
Primary outcome
Caregiver Burden - The Zarit Burden Interview-12 (ZBI-12) - 3 months
Time frame: 3 months post-enrollment or post intervention initiation
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.
13 secondary outcomes
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
Connor-Davidson Resilience Scale-10 (CD-RISC 10) - 6 months
Time frame: 6 months post-enrollment or post intervention initiation
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Michael J Goldfarb, MD, MSc principal investigator
Lady Davis Institute, McGill University, Jewish General Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Virtual peer support group intervention, Caregiver Support intervention and Resources in people with Family Engagement and Critical Care, Intensive Care, run by Lady Davis Institute at 2 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 22 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jillian Kifell, MSc (5143408222 ext. 25806, jillian.kifell.ccomtl@ssss.gouv.qc.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Caregiver Burden - The Zarit Burden Interview-12 (ZBI-12) - 3 months (time frame: 3 months post-enrollment or post intervention initiation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 May 2025.