Family Engagement, Critical Care, Intensive Care, Patient and Family Engagement, Health Care Delivery, Family-centered Care, Pilot Study, Caregiver, Caregiver Burden, Family Caregivers
Conditions
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
Brief 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. 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.
Interventions
BEHAVIORALVirtual 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.
BEHAVIORALCaregiver Support intervention
The caregiver support intervention is a personalized program designed to improve quality of life, reduce fatigue and caregiver burden, and build resilience.
OTHERResources
Participants will be given a list of resources to contact in case of emotional or psychological distress.
Sponsors
Lady Davis Institute
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
DOUBLE (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Caregiver Burden - The Zarit Burden Interview-12 (ZBI-12) - 3 months | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Caregiver Burden - The Zarit Burden Interview-12 (ZBI-12) - 6 months | 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. |
| Multidimensional Scale of Perceived Social Support (MSPSS) - 3 months | 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. |
| Multidimensional Scale of Perceived Social Support (MSPSS) - 6 months | 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. |
| Patient Health Questionnaire-9 (PHQ-9) - 3 months | 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. |
| Patient Health Questionnaire-9 (PHQ-9) - 6 months | 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. |
| Post-traumatic stress (IES-Revised) - 3 months | 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. |
| Post-traumatic stress (IES-Revised) - 6 months | 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. |
| Connor-Davidson Resilience Scale-10 (CD-RISC 10) - 3 months | 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. |
| Connor-Davidson Resilience Scale-10 (CD-RISC 10) - 6 months | 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. |
| Insomnia Severity Index (ISI) - 3 months | 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). |
| Insomnia Severity Index (ISI) - 6 months | 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). |
| Quality of life (EuroQOL-5D-5L score) - 3 months | 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 |
| Quality of life (EuroQOL-5D-5L score) - 6 months | 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 |
Other
| Measure | Time frame | Description |
|---|---|---|
| FAM-Activate (FAM-A) | 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. |
| FAMily Engagement (FAME) | 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. |
Countries
Canada
Contacts
Primary ContactJillian Kifell, MSc
Outcome results
None listed