An interventional study of Virtual peer support group intervention and Caregiver Support intervention in Family Engagement, Critical Care, Intensive Care and Patient and Family Engagement, sponsored by Lady Davis Institute. Not yet recruiting at 2 sites in Canada. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-05-22.
Sponsored by Lady Davis Institute · Not applicable, Interventional, and Health services research
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:
Participants will:
500 studies on the registry are indexed under Caregiver Burden; 164 are open to participants now.
This study's planned enrollment of 60 is below the median of 71 across 402 interventional studies indexed under Caregiver Burden.
Browse Caregiver Burden studies →Lady Davis Institute is the lead sponsor of 46 studies on the registry; 7 are open to participants now.
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Exclusion Criteria:
Participants will be given a list of resources for emotional or psychological distress.
Other: Resources
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
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.
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.
Time frame: 3 months post-enrollment or post intervention initiation
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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).
Time frame: 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).
Time frame: 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
Time frame: 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
Time frame: 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.
Time frame: 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.
Time frame: 6 months post-enrollment or post intervention initiation
FAM-Activate (FAM-A)
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
FAMily Engagement (FAME)
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.
Time frame: completed at enrolment in the study
Plan to share: No
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