Clinical trial NCT06727461: Effects of FEED@Home Intervention
Official title: Effects of a Home-based Feeding EnhancEment in Dementia (FEED@Home) Intervention on Hospital Readmissions: A Multicenter Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Dementia
Dementia Severe
Keywords: Advanced dementia
Careful hand feeding
Feeding difficulties
Lead sponsor: The University of Hong Kong
Sponsor class: OTHER
First posted: 2024-12-10
Enrollment: 180
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This is a single-blinded multicenter randomized controlled trial to evaluate the effects of the FEED@home intervention.

Each patient-family dyad will be randomized in a 1:1 ratio to FEED@home program vs. usual care after completing the baseline interview. Allocation sequence will be generated by a computer program using random block sizes of 4, 8 and 12. The sequence will be put in sequentially numbered opaque sealed envelopes to ensure concealment.
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief 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

Detailed description: To improve in-home post-discharge management of feeding difficulties in advanced dementia patients, our research team members developed the FEED@home intervention with the goals of reducing potentially avoidable hospital readmissions and improving quality of life of advanced dementia patients with feeding difficulties.

This Feed@home intervention was based on existing experience in leading hospital careful hand feeding programs in Hong Kong and a pilot study on the Feeding EnhancEment in Dementia (FEED) program which consists of a hospital-based multidisciplinary intervention and two post-discharge outpatient visits with a speech therapist.

Informed by those experiences, post-discharge follow-up can be enhanced as a hybrid in-home and teleconsultation support service delivered by a speech therapist and nurse team to enable timely support to dementia patients and family caregivers in the home environment post discharge.

We hypothesize that FEED@home can significantly reduce unplanned all-cause and feeding problem-related hospital readmissions, prolong sustainability on oral feeding, reduce feeding difficulty, lessen malnutrition risk, improve quality of life of patients, improve family caregiver satisfaction, and alleviate their care burden.

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

Primary outcomes:
measure: Number of unplanned all-cause hospital readmissions
timeFrame: 6-month
Secondary outcomes:
measure: Number of unplanned all-cause hospital readmissions
timeFrame: 1-month, 2-month, and 3-month
measure: Time to first unplanned all-cause hospital readmission
timeFrame: 1-month, 2-month, 3-month and 6-month
measure: Number of unplanned feeding-mode related hospital readmissions
timeFrame: 1-month, 2-month, 3-month and 6-month
measure: Time to first unplanned feeding mode related hospital readmission
timeFrame: 1-month, 2-month, 3-month and 6-month
measure: Time to conversion to tube feeding
timeFrame: 6-month
measure: Edinburgh Feeding Evaluation in Dementia Questionnaire-Chinese version (C-EdFED-Q)
timeFrame: Baseline, 2-month, and 6-month
measure: Mini Nutritional Assessment-Short Form (MNA-SF)
timeFrame: Baseline, 2-month, 6-month
measure: Quality of Life in Late-Stage Dementia Scale-Chinese version (QUALID-C)
timeFrame: Baseline, 2-month, and 6-month
measure: Satisfaction with Care Questionnaire
timeFrame: Baseline, 2-month, and 6-month
measure: Zarit Burden Interview Scale-Cantonese version (CZBI)
timeFrame: Baseline, 2-month, and 6-month
Other outcomes:
measure: Qualitative interview
timeFrame: 6-month
Locations:
city: Hong Kong
country: Hong Kong
facility: Queen Mary Hospital
Study officials:
affiliation: The University of Hong Kong
name: Jacqueline Yuen, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
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