Incidence and Factors Associated to the Development of PICS-F Among ICU Relatives: A Longitudinal… (NCT05827354) | Clinical Trial Compass
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Incidence and Factors Associated to the Development of PICS-F Among ICU Relatives: A Longitudinal Exploratory Study
Chile175 participantsStarted 2023-06-27
Plain-language summary
The constellation of long-term psychological, physical, and cognitive impairments arising after a critical illness among family members of ICU survivors has been labeled as "Post Intensive Care Syndrome - Family" (PICS-F). Despite PICS-F awareness, the long-term issues faced by ICU family members remain poorly understood with several gaps in knowledge remaining such as the role of protective psychosocial factors, caregiver burden, or family satisfaction in the development of the syndrome.
This single-center, longitudinal exploratory study, aims to determine the incidence of each PICS-F impairment (psychological, physical, and cognitive) and to identify factors (during ICU stay and after hospital discharge) associated with the development or prevention of the PICS-F impairments among family members of ICU survivors of a public hospital in Chile.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
All adult family members (≥ 18 years old) identified as the patient´s representative, Spanish speakers, and likely to become responsible for providing and/or coordinating patient care after hospital discharge will be eligible.
Besides, the patient must have between 48 hours and 10 days in the ICU, be \> 18 years old, and receive respiratory support (noninvasive ventilation, high-flow nasal cannula, or invasive mechanical ventilation).
Exclusion Criteria:
Family members of ICU patients with a high impending death risk (including end-of-life care / only comfort measures) or likely to be discharged from the ICU in the following 24 hours will be excluded.
Subjects (family members) will be withdrawn from the study at any point if the patient dies.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This study is tracking how family members of ICU patients are affected mentally, physically, and cognitively — a condition called PICS-F — and since I'm caring for someone who has been or may be in the ICU, could you help me understand whether being followed in a study like this might give me access to monitoring or support I wouldn't otherwise receive?
2Since this is an observational study measuring how often psychological, physical, and cognitive problems develop in ICU relatives over time, rather than testing a treatment, what does that mean for what I'd actually be asked to do as a participant, and would there be any direct benefit to me?
3Given that the recruitment status of this trial is currently unknown, do you know whether this study is still actively enrolling participants, and if not, are there similar studies or programs nearby that track and support family members of ICU patients?
4Because PICS-F can involve anxiety, depression, physical strain, and cognitive difficulties in caregivers, should I be getting screened for these issues regardless of whether I join this study, and what support resources exist for me right now as a caregiver?
5This study also looks at factors like social support and resilience as they relate to PICS-F — based on my own situation and support network, do you think I'm at higher risk for developing these problems, and what steps could we take together to address that proactively?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Incidence of psychological impairment in family members of ICU survivors
Timeframe: 3 months after hospital discharge
2
Incidence of psychological impairment in family members of ICU survivors
Timeframe: 6 months after hospital discharge
3
Incidence of physical impairment in family members of ICU survivors
Timeframe: 3 months after hospital discharge
4
Incidence of physical impairment in family members of ICU survivors
Timeframe: 6 months after hospital discharge
5
Incidence of cognitive impairment in family members of ICU survivors
Timeframe: 3 months after hospital discharge
6
Incidence of cognitive impairment in family members of ICU survivors