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DementiaNCT06727461

Effects of FEED@Home Intervention

A study testing Home-based Feeding EnhancEment in Dementia (Feed@home) in people with Dementia and Dementia Severe, run by The University of Hong Kong at 1 site in Hong Kong.

Enrolling by invitation

Enrolling by invitation. The study team selects and invites participants, usually from an existing group of patients.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 60 years and older
Conditions the study is for
Dementia, Dementia Severe
What is being tested?
Home-based Feeding EnhancEment in Dementia (Feed@home)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
180 participants
Where
1 siteHong Kong
Study dates
23 Jul 2024to Dec 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 60 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
Show all 11Show fewer
  • Has available legally authorized representative (e.g. next of kin) who can provide informed consent for patient
  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Hong Kong1 site

  • Queen Mary Hospital

    Hong Kong

Other trials in Hong Kong

About this study

Official title: Effects of a Home-based Feeding EnhancEment in Dementia (FEED@Home) Intervention on Hospital Readmissions: A Multicenter Randomized Controlled Trial

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:

Read more
  • 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
Read the 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.

Being tested
Home-based Feeding EnhancEment in Dementia (Feed@home)
Keywords
Advanced dementia, Careful hand feeding, Feeding difficulties
Medical subject headings
Dementia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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

    Also called Feed@home program

    The FEED@home program is an 8-week initiative led by a speech therapist (ST) and nurse team through teleconsultations and home visits:

    • Within 3 days after discharge, a nurse teleconsultation with the family caregiver to assess the patient's mealtime behaviors and provide feeding strategy recommendations and educational materials.
    • Two to three home visits by STs during mealtime (depending on the mastery of feeding techniques) to assess swallowing and cognitive feeding issues, providing tailored interventions and proper training of feeding techniques.
    • Two teleconsultations by nurses to assess the caregiver's techniques and provide additional training.
    • One additional home visit during mealtime by a nurse to assess the caregiver's mastery of the feeding techniques through observation.
    • The program lasts 8 weeks, regardless of readmissions, unless the patient converts to tube feeding, moves to a care home, passes away, or withdraws from study.
Study groups in NCT06727461
Study groupRoleWhat they receive
Home-based Feeding EnhancEment in Dementia (Feed@home)ExperimentalFEED@home program is an 8-week post-discharge intervention delivered by a nurse and speech therapist team. * Within 3 days after discharge, nurse conducts teleconsultation (30-45 minutes/session) with caregiver to assess feeding issues, offer recommendations and education materials. * Week 1 and 2, speech therapist conducts 2 home visits (45 - 60 minutes/session) to assess feeding issues at home and provide caregiver training. * Week 4, nurse teleconsultation (30 - 45 minutes) to assess for difficulties with managing feeding problems, provide recommendations, and anticipatory planning. * Week 5 - home visit by nurse (45 - 60 minutes) to assess caregivers' mastery of feeding strategies and assess patient's feeding difficulty using C-EdFED-Q scale. If C-EdFED-Q score is ≥10, a 3rd home visit by speech therapist will be arranged in - Week 6 - nurse conducts final teleconsultation (30 - 45 minutes) to assess feeding issues, offer reommendations and education.
Receives: Other: Home-based Feeding EnhancEment in Dementia (Feed@home)
ControlNo interventionThe patient will receive usual care from the hospital and follow-up care as instructed by the hospital.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of unplanned all-cause hospital readmissions

    The total number of unplanned all-cause hospital readmissions within the specified time frame will be obtained from electronical medical system. Family caregivers will report any unplanned admissions to private hospitals during the study period.

    Measured: 6-month

Secondary outcomes (10)

  1. Number of unplanned all-cause hospital readmissions

    The total number of unplanned all-cause hospital readmissions within the specified time frame will be obtained from electronical medical system. Family caregivers will report any unplanned admissions to private hospitals during the study period.

    Measured: 1-month, 2-month, and 3-month

  2. Time to first unplanned all-cause hospital readmission

    The date of first hospital readmission will be obtained based on a review of medical records. The time from discharge date to the date of first all-cause hospital readmission will be calculated.

    Measured: 1-month, 2-month, 3-month and 6-month

  3. Number of unplanned feeding-mode related hospital readmissions

    The total number of unplanned feeding mode related hospital readmissions within the specified time frame will be obtained from electronic medical system. Family caregivers will report any unplanned admissions to private hospitals related to feeding mode during the study period.

    Measured: 1-month, 2-month, 3-month and 6-month

  4. Time to first unplanned feeding mode related hospital readmission

    The time from discharge to the first hospital readmission related to feeding mode will be documented, including the specific date of readmission.

    Measured: 1-month, 2-month, 3-month and 6-month

  5. Time to conversion to tube feeding

    The time to conversion to tube feeding will be counted from the discharge date to the date of feeding tube insertion within 6 months, which reflects the sustainability of oral feeding. The timing of feeding tube insertion will be recorded based on a review of medical records.

    Measured: 6-month

  6. Edinburgh Feeding Evaluation in Dementia Questionnaire-Chinese version (C-EdFED-Q)

    C-EdFED-Q will assess the patient's feeding difficulty by caregiver's rating of observable feeding behaviors at mealtimes (11 items rated on a 3-point scale from 1 'never' to 2 'often,' score range 0-20; 20=highest difficulty). The C-EdFED-Q has been shown to have good interrater reliability, internal consistency, and construct validity.

    Measured: Baseline, 2-month, and 6-month

  7. Mini Nutritional Assessment-Short Form (MNA-SF)

    MNA-SF assess the malnutrition risk of patients by interviewing the family caregiver. The MNA-SF is a validated 6-item tool for assessing malnutrition in older adults including Chinese patients.24-25 The items assess food intake, unintended weight loss, mobility, acute disease, neuropsychological problems, and BMI or calf circumstance if BMI is unavailable (range 0-14 points, <7 points indicates a state of malnutrition, 7 to 11 at risk of malnutrition, > 11 normal nutritional status)

    Measured: Baseline, 2-month, 6-month

  8. Quality of Life in Late-Stage Dementia Scale-Chinese version (QUALID-C)

    QUALID-C will assess the quality of life of patients with advanced dementia. The QUALID-C is a validated 11-item scale rated on a 5-point Likert scale based on caregivers report of observable behaviors of people with severe dementia (range 11-55; lower score indicates higher QoL). The QUALID-C has demonstrated excellent reliability, internal consistency, and validity.

    Measured: Baseline, 2-month, and 6-month

  9. Satisfaction with Care Questionnaire

    Satisfaction with Care Questionnaire is modified from the questionnaire developed by the Hospital Authority Quality and Safety Subcommittee to assess family caregivers' satisfaction with care services provided to support careful hand feeding (Reference Manual). The 7-item questionnaire is rated on a 5-point Likert scale (1=strongly disagree; 5=strongly agree.

    Measured: Baseline, 2-month, and 6-month

  10. Zarit Burden Interview Scale-Cantonese version (CZBI)

    This scale will assess caregiver burden by interviewing the family caregiver. The 12-item CZBI-Short is rated on a 5-point Likert scale and has been demonstrated to be a reliable and valid instrument to assess burden in Chinese dementia caregivers

    Measured: Baseline, 2-month, and 6-month

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Dec 2024
  2. Study start23 Jul 2024
  3. Primary completionJun 2027 (estimated)
  4. Study completionDec 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Health services research
Allocation
Randomised
Intervention model
Parallel groups
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.
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
180 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06727461
Sponsor's protocol ID
21223191
Status last verified
Sep 2026
First submitted
3 Jun 2024
Last updated
8 Sep 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: The individual participant data will be collected and stored confidentially. Electronic data files will be password-protected in encrypted storage devices. Paper data files will be kept in secure file cabinets in a locked office at the study sites. Access to files will be restricted to key study personnel and supervised by the principal investigator of the study. There is no plan for IPD sharing.

Publications

  • Mitchell SL, Teno JM, Kiely DK, Shaffer ML, Jones RN, Prigerson HG, Volicer L, Givens JL, Hamel MB. The clinical course of advanced dementia. N Engl J Med. 2009 Oct 15;361(16):1529-38. doi: 10.1056/NEJMoa0902234.

    PubMed 19828530

  • Cintra MT, de Rezende NA, de Moraes EN, Cunha LC, da Gama Torres HO. A comparison of survival, pneumonia, and hospitalization in patients with advanced dementia and dysphagia receiving either oral or enteral nutrition. J Nutr Health Aging. 2014 Dec;18(10):894-9. doi: 10.1007/s12603-014-0487-3.

    PubMed 25470805

  • Chou HH, Tsou MT, Hwang LC. Nasogastric tube feeding versus assisted hand feeding in-home healthcare older adults with severe dementia in Taiwan: a prognosis comparison. BMC Geriatr. 2020 Feb 14;20(1):60. doi: 10.1186/s12877-020-1464-9.

    PubMed 32059646

  • Kelly S, Lafortune L, Hart N, Cowan K, Fenton M, Brayne C; Dementia Priority Setting Partnership. Dementia priority setting partnership with the James Lind Alliance: using patient and public involvement and the evidence base to inform the research agenda. Age Ageing. 2015 Nov;44(6):985-93. doi: 10.1093/ageing/afv143.

    PubMed 26504119

  • Finucane TE, Christmas C, Travis K. Tube feeding in patients with advanced dementia: a review of the evidence. JAMA. 1999 Oct 13;282(14):1365-70. doi: 10.1001/jama.282.14.1365.

    PubMed 10527184

  • Davies N, Barrado-Martin Y, Vickerstaff V, Rait G, Fukui A, Candy B, Smith CH, Manthorpe J, Moore KJ, Sampson EL. Enteral tube feeding for people with severe dementia. Cochrane Database Syst Rev. 2021 Aug 13;8(8):CD013503. doi: 10.1002/14651858.CD013503.pub2.

    PubMed 34387363

  • Lee YF, Hsu TW, Liang CS, Yeh TC, Chen TY, Chen NC, Chu CS. The Efficacy and Safety of Tube Feeding in Advanced Dementia Patients: A Systemic Review and Meta-Analysis Study. J Am Med Dir Assoc. 2021 Feb;22(2):357-363. doi: 10.1016/j.jamda.2020.06.035. Epub 2020 Jul 29.

    PubMed 32736992

  • DiBartolo MC. Careful hand feeding: a reasonable alternative to PEG tube placement in individuals with dementia. J Gerontol Nurs. 2006 May;32(5):25-33; quiz 34-5. doi: 10.3928/00989134-20060501-06.

    PubMed 16708981

  • Luk JKH, Chan TC, Chan FHW. Letter to the Editor: Careful hand feeding program in a geriatric step-down hospital in Hong Kong - is this feasible? J Frailty Aging. 2021;10(3):303-304. doi: 10.14283/jfa.2020.50. No abstract available.

    PubMed 34105718

  • Yuen JK, Chan FHW, Chan TC, Chow DTY, Chu ST, Shea YF, Luk JKH. Hospital Careful Hand Feeding Program Reduced Feeding Tube Use in Patients with Advanced Dementia. J Nutr Health Aging. 2023;27(6):432-437. doi: 10.1007/s12603-023-1926-9.

    PubMed 37357327

  • Yuen JK, Luk JKH, Chan TC, Shea YF, Chu ST, Bernacki R, Chow DTY, Chan FHW. Reduced Pneumonia Risk in Advanced Dementia Patients on Careful Hand Feeding Compared With Nasogastric Tube Feeding. J Am Med Dir Assoc. 2022 Sep;23(9):1541-1547.e2. doi: 10.1016/j.jamda.2022.03.011. Epub 2022 Apr 27.

    PubMed 35489380

Questions about this trial

What is this clinical trial studying?

A study testing Home-based Feeding EnhancEment in Dementia (Feed@home) in people with Dementia and Dementia Severe, run by The University of Hong Kong at 1 site in Hong Kong.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: enrolling by invitation, as of the sponsor's last update on 8 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of unplanned all-cause hospital readmissions (time frame: 6-month). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06727461, which also lists 11 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Sep 2026.

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