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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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control Group: Resources only | Active Comparator | Participants will be given a list of resources for emotional or psychological distress. |
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| 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'. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 6 months post-enrollment or post intervention initiation |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jillian Kifell, MSc | Contact | 5143408222 | 25806 | jillian.kifell.ccomtl@ssss.gouv.qc.ca |
| Name | Affiliation | Role |
|---|---|---|
| Michael J Goldfarb, MD, MSc | Lady Davis Institute, McGill University, Jewish General Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Jewish General Hospital | Montreal | Quebec | Canada |
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| ID | Term |
|---|---|
| D000084802 | Caregiver Burden |
| ID | Term |
|---|---|
| D013315 | Stress, Psychological |
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
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| ID | Term |
|---|---|
| D006295 | Health Resources |
| ID | Term |
|---|---|
| D006285 | Health Planning |
| D004472 | Health Care Economics and Organizations |
| D003695 | Delivery of Health Care |
| D017530 | Health Care Quality, Access, and Evaluation |
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| 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. |
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| Resources | Other | Participants will be given a list of resources to contact in case of emotional or psychological distress. |
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| 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. | 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. | 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. | 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. | 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. | 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. | 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). | 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). | 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 | 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 | 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. | 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. | 6 months post-enrollment or post intervention initiation |
| 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. | completed at enrolment in the study |
| McGill University Health Centre | Montreal | Quebec | Canada |
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