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Search / Trial NCT06727461

Effects of FEED@Home Intervention

Launched by THE UNIVERSITY OF HONG KONG · Dec 6, 2024

Trial Information

Current as of October 26, 2025

Enrolling by invitation

Keywords

Advanced Dementia Careful Hand Feeding Feeding Difficulties

ClinConnect Summary

This study is testing FEED@home, an 8-week, home-based program designed for people with advanced dementia who have trouble feeding after leaving the hospital. The goal is to see if FEED@home can reduce unplanned hospital readmissions and improve feeding, nutrition, quality of life for the person with dementia, and satisfaction and burden for the family caregiver compared with usual post-discharge care. It’s a single-blind, multicenter trial in Hong Kong, run by The University of Hong Kong, and participants will be followed for 6 months to look at several feeding-, nutrition-, and caregiver-related outcomes.

Who can join: caregiver-patient pairs where the patient is 60 or older with moderately to severely advanced dementia, has feeding problems due to swallowing or cognitive issues, is eating by mouth at discharge, and lives at home with a caregiver who helps with most meals. Key exclusions include having a feeding tube already, being discharged to a care facility, or not having a caregiver at home. If eligible, you’ll be randomly assigned to FEED@home or usual care. For those in FEED@home, expect a nurse phone check within 3 days of discharge, 2–3 home visits by a speech therapist in weeks 1–3, then additional nurse visits and phone check-ins through week 8, with a possible extra visit if needed. The study will measure hospital readmissions at 1, 2, 3, and 6 months, plus several questions about feeding, nutrition, quality of life, and caregiver experience, including a 6-month interview to assess how practical and acceptable the program is. The trial plans to enroll about 180 pairs and results are expected around 2026.

Gender

ALL

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

About The University Of Hong Kong

The University of Hong Kong (HKU) is a leading research institution dedicated to advancing medical knowledge and improving healthcare outcomes through innovative clinical trials. With a commitment to excellence in research and education, HKU collaborates with various stakeholders, including healthcare providers and industry partners, to conduct rigorous and ethically sound clinical studies. The university's diverse expertise and state-of-the-art facilities enable it to explore a wide range of therapeutic areas, contributing to the global pursuit of scientific advancement and the development of novel treatment strategies.

Locations

Hong Kong, Hong Kong

Patients applied

0 patients applied

Trial Officials

Jacqueline Yuen, M.D.

Principal Investigator

The University of Hong Kong

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported