Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 12:06 AM
Ignite Modification Date:
2025-12-25 @ 12:06 AM
NCT ID:
NCT02932358
Eligibility Criteria:
Inclusion Criteria:
* For ICUs: medical-surgical ICUs of of public and philanthropic Brazilian hospitals with restricted visitation policies(\<4.5 hours/day).
* For Patients: Age ≥ 18 years, admission to the intensive care unit.
* For Patient's Family Members: nearest relative of the ICU patient recruited in the study and consent to participate in the study.
* For ICU Workers: ICU workers that assist patients in the ICU during the daytime for at least 20 hours per week and consent to participate in the study.
Exclusion Criteria:
* For ICUs: ICUs with structural or organizational impediments to extended visitation.
* For Patients: Subjects with coma (Richmond Agitation Sedation Scale -4 or -5) lasting \> 96 hours from the moment of first evaluation for recruitment, or delirium at the baseline (positive Confusion Assessment Method for ICU) will be excluded. Individuals with cerebral death, aphasia, severe hearing deficit, a prediction of ICU length of stay \< 48 hours, exclusively palliative treatment, or without a familiar member able to participate in extended ICU visits and those who are prisioners, unlikely to survive \>24hs, re-admitted to the ICU after enrolment in the study will also be excluded.
* For Patient's Family Members: Another ICU patient's relative enrolled in the study; family members who don't speak Portuguese; Difficulty to answer the self-administered questionnaires (e.g.: illiteracy)
* For ICU Workers: ICU workers who have a prediction of withdrawal of ICU care activities \>15 days during the study will be excluded.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02932358
Study Brief:
Protocol Section:
NCT02932358