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Enrolling By Invitation
NCT06727461
Effects of FEED@Home Intervention
Conditions: Dementia, Dementia Severe
Sex: All
Ages: 60 Years – N/A
Healthy volunteers: No
Phase: NA
Enrollment: 180
Sponsor: The University of Hong Kong
Location: Queen Mary Hospital Hong Kong
Summary
The main goal of this single-blinded multicenter randomized trial is to learn if the 8-week home-based Feeding EnhancEment in Dementia program (FEED@home) works to improve unplanned hospital utilization of advanced dementia patients with feeding problems who reside at home after discharge from hospital. It will also investigate the effect of Feed@home program on outcomes including feeding problem-related readmissions, sustainability on oral feeding, feeding difficulty, malnutrition risk, quality of life of patients with dementia, caregiver satisfaction with care, and caregiver burden.
The questions it aims to answer are:
* Does Feed@home intervention reduce unplanned all-cause hospital readmissions of advanced dementia patients with feeding problems at 1, 2, 3, and 6 months after discharge from the hospital?
* Does Feed@home intervention improve the outcomes including feeding problem-related readmissions, sustainability on oral feeding, feeding difficulty, malnutrition risk, quality of life of patients with dementia, caregiver satisfaction, and burden with care?
Investigators will compare Feed@home intervention to usual care after discharge to see if the Feed@home program improves the outcomes of patients and caregivers. The Feed@home program includes an 8-week follow-up care by speech therapists and nurses via home visits and teleconsultations.
Participants will be dyads of patients and their caregivers, and they will:
* Receive Feed@home intervention or usual care after discharge
* Give consent for access to patients' information and hospital records
* Caregivers to complete questionnaire at recruitment and 2 and 6 months after discharge
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
Source: ClinicalTrials.gov (NCT06727461). StuddyBuddy aggregates publicly available trial information.