Effects of FEED@Home Intervention

The University of Hong Kong (HKU)

Status: Invitation-only

Conditions: Dementia Severe; Dementia

Treatments: Other: Home-based Feeding EnhancEment in Dementia (Feed@home)

Study type: Interventional

Funder types: Other

Identifiers

NCT06727461

21223191

Details and patient eligibility

About

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

Full 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.

Enrollment: 180 estimated patients

Sex: All

Ages: 60+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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180 participants in 2 patient groups

Home-based Feeding EnhancEment in Dementia (Feed@home)

Experimental group

Description:

1. Within 3 days after discharge, a nurse will conduct a teleconsultation (30-45 minutes) with the caregiver to assess feeding issues, and offer recommendations and caregiver education materials on feeding strategies. 2. In Weeks 1-3 after discharge, there will be 2 home visits by speech therapists (each time 45 - 60 minutes) to assess feeding issues at home and provide instructions on feeding techniques and training. 3. In week 4, there will be a teleconsultation with the nurse (30 - 45 minutes) to discuss any problems arising. 4. In Weeks 5-8 after discharge, there will be a home visit by nurse (45 - 60 minutes), followed by a teleconsultation with the nurse in the final week (30 - 45 minutes). An additional visit by the speech therapist may be arranged if needed. 5. The intervention will be resumed after any pauses resulting from patient readmissions to the hospital.

Treatment:

Other: Home-based Feeding EnhancEment in Dementia (Feed@home)

Control

No Intervention group

Description:

The patient will receive usual care from the hospital and follow-up care as instructed by the hospital.