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:
2025-12-24 @ 11:18 PM
Ignite Modification Date:
2025-12-24 @ 11:18 PM
NCT ID:
NCT03718156
Eligibility Criteria:
Inclusion Criteria:
* has dementia and/or cognitive impairment (as determined by discussions with the nursing staff and chart abstraction);
* a minimum length of stay in the LTC institution of at least two weeks prior to the start of the baseline assessments;
* at high risk of delirium, as indicated by a score of 3 or higher on a validated 5-item delirium risk screening tool;
* delirium-free at baseline, as assessed by the Confusion Assessment Method (CAM), the Delirium Index (DI) and a brief chart review over a screening period of two consecutive weeks.
Exclusion Criteria:
* unable to communicate verbally in English or French (as determined by either the nursing staff or two consecutive 0-score administrations of the composite cognitive interview at screening);
* has a history of specific psychiatric conditions (bipolar disorder, depression with signs of psychosis, and psychotic disorders) or intellectual disability;
* is receiving comfort/end-of-life care.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
65 Years
Study:
NCT03718156
Study Brief:
Protocol Section:
NCT03718156