NCT Number: NCT06984770
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.
Trial opening soon.
Get Notified18 year and older
All sexes
Interventional
Not applicable
Jewish General Hospital, Montreal, Quebec, Canada
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
The caregiver support intervention is a personalized program designed to improve quality of life, reduce fatigue and caregiver burden, and build resilience.
Participants will be given a list of resources to contact in case of emotional or psychological distress.
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.
Time frame: 6 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.
Time frame: 3 months post-enrollment or post intervention initiation
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.
Time frame: 6 months post-enrollment or post intervention initiation
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.
Time frame: 3 months post-enrollment or post intervention initiation
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.
Time frame: 6 months post-enrollment or post intervention initiation
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.
Time frame: 3 months post-enrollment or post intervention initiation
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.
Time frame: 6 months post-enrollment or post intervention initiation
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.
Time frame: 3 months post-enrollment or post intervention initiation
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).
Time frame: 6 months post-enrollment or post intervention initiation
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).
Time frame: 3 months post-enrollment or post intervention initiation
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
Time frame: 6 months post-enrollment or post intervention initiation
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
Time frame: 3 months post-enrollment or post intervention initiation
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.
Time frame: 6 months post-enrollment or post intervention initiation
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.
Time frame: completed at enrolment in the study
The FAM-Activate (FAM-A) tool is a self-administered 4-item questionnaire that assesses an individual's current activation. FAM-A uses a five-point Likert scale ranging from 1 (strongly agree) to 5 (strongly disagree), and scale results are changed to a 0-100 scoring system, with higher scores indicating greater activation. Activation refers to the knowledge, skills, and confidence of a family member.
Time frame: completed at enrolment in the study
The FAMily Engagement (FAME) tool is a self-administered 12-item questionnaire that assesses an individual's current engagement practice. FAME uses a five-point Likert scale ranging from 1 (strongly agree) to 5 (strongly disagree), and scale results are changed to a 0-100 scoring system, with higher scores indicating greater engagement in care. The following subdomains are evaluated: engagement perception, family presence, communication, education, decision-making, care contribution, and family needs. FAME includes the following engagement domains: family presence, family needs, communication and education, decision making, and direct care. FAME also captures the following family-centered care principles: dignity and respect, information sharing, participation, and collaboration.
Contact information is provided by the study sponsor or research team.
Lady Davis Institute
Other
Caring for the Caregiver: A Pilot Randomized Controlled Trial (The Family Cares Trial)
Acronym: Family Cares
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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