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 @ 12:56 PM
Ignite Modification Date:
2025-12-24 @ 12:56 PM
NCT ID:
NCT06727461
Eligibility Criteria:
Subjects are dyads of dementia patients and family caregivers.
Inclusion Criteria (For patients):
* Age ≥ 60 years old
* Diagnosis of dementia based on DSM-5 Criteria for Major Neurocognitive Disorder
* Moderately severe to severe dementia as defined by Stage 6 or above on the Functional Assessment Staging Test
* Has indication for tube feeding due to severe feeding difficulties identified by the medical team (cognitive feeding issues and/or oropharyngeal dysphagia) and family surrogate opted for oral feeding
* Maintained on oral feeding at the time of discharge
* Reside at home after discharge
* Has available legally authorized representative (e.g. next of kin) who can provide informed consent for patient
Exclusion Criteria(For patients):
* Any type of feeding tube at time of discharge
* Discharged to residential care homes, respite care or hospice facilities
* No available family caregiver at home
Inclusion Criteria (For family caregivers ):
* Age ≥ 18 years old or above
* Main caregiver who provides or supervises feeding assistance to the patient for ≥70% of meals
* Able to provide informed consent
Exclusion Criteria (For family caregivers ): No specific exclusion criteria
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
60 Years
Study:
NCT06727461
Study Brief:
Protocol Section:
NCT06727461