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 @ 5:26 PM
Ignite Modification Date:
2025-12-24 @ 5:26 PM
NCT ID:
NCT05255068
Eligibility Criteria:
The investigators will recruit direct care staff, families of residents, and residents with dementia from NH sites following the exclusion and inclusion criteria after attrition rates are considered.
Inclusion Criteria:
Residents
* ≥ 55 years
* Diagnosed as having ADRD based on medical records
* Identified by NH staff as requiring mealtime assistance
* Having a legally authorized representative (LAR) providing informed written consent
Staffs
* ≥18 years
* English speaking
* A permanent facility employee
* Provide direct mealtime care for a resident participant at least twice a week over the previous month
Families
* ≥18 years
* English speaking
* A family member of the resident who is living at the NH study site at the time of the study
* Having experience of delivering mealtime care to their resident family members
Exclusion Criteria:
Residents
* Have a documented diagnosis of Parkinson's disease, traumatic brain injury, or swallowing disorder,
* Do not eat orally (e.g., parenteral/IV feedings, feeding tubes)
* Unable to hear or see staff even with glasses and/or hearing aids (e.g., uncorrected visual or hearing impairment)
* Stay in the NH study site for less than 12 weeks at the time of recruitment/consent/assent (e.g., terminally ill receiving hospice services, and/or receiving post-hospital skilled rehabilitation) that may not allow enough time for obtaining consent/assent, and scheduling days for video recording sessions across three-time points (baseline, and 6- and 12- weeks post-baseline)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT05255068
Study Brief:
Protocol Section:
NCT05255068