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 @ 5:49 PM
Ignite Modification Date:
2025-12-24 @ 5:49 PM
NCT ID:
NCT04373668
Eligibility Criteria:
Inclusion Criteria:
* Care homes (inclusive of residential and nursing) that have failed to meet more than 1 of the 5 CQC care home quality standards check
* Care homes who have at least 12 eligible care home resident participants
* Care homes with a minimum of two residents who are eligible to participate in the study taking hypnotic medication
* Resident participants will have an established or probable diagnosis of dementia
* Residents will have experienced an episode/occurrence of sleep disturbance behaviour in the past four weeks/two weeks (as reported by care staff)
* Care home member of staff whose duties include providing care to individuals with dementia
* Care home care staff are required to have an adequate level of English language to complete all required assessment outcomes
* Care home care staff participants who will remain in work without plans for extended leave over the study period
Exclusion Criteria:
* Care homes receiving special support from the local authority
* Agency care staff
* Care staff will be able to withdraw from the study at any time
Healthy Volunteers:
False
Sex:
ALL
Study:
NCT04373668
Study Brief:
Protocol Section:
NCT04373668