Effects of FEED@Home Intervention

NCT06727461 | Enrolling By Invitation

• 1 other identifier: 21223191
• Study Type: interventional
• Target: 180
• Locations: 1 country
• Sites: 1

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

Conditions

Dementia; Dementia Severe

Keywords

Advanced dementia; Careful hand feeding; Feeding difficulties

Outcome Measures

Primary Outcomes (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.

  6-month

Secondary Outcomes (10)

• Number of unplanned all-cause hospital readmissions

  1-month, 2-month, and 3-month

• Time to first unplanned all-cause hospital readmission

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

• Number of unplanned feeding-mode related hospital readmissions

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

• Time to first unplanned feeding mode related hospital readmission

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

• Time to conversion to tube feeding

  6-month

Other Outcomes (1)

• Qualitative interview

  6-month

Study Arms (2)

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

EXPERIMENTAL

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.

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

Control

NO INTERVENTION

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

Interventions

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

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.

Also known as: Feed@home program

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

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• The University of Hong Kong: lead

Study Sites (1)

Queen Mary Hospital

Hong Kong, Hong Kong

Location

Related Publications (11)

• 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.

  PMID: 19828530 BACKGROUND

• 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.

  PMID: 25470805 BACKGROUND

• 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.

  PMID: 32059646 BACKGROUND

• 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.

  PMID: 26504119 BACKGROUND

• 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.

  PMID: 10527184 BACKGROUND

• 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.

  PMID: 34387363 BACKGROUND

• 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.

  PMID: 32736992 BACKGROUND

• 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.

  PMID: 16708981 BACKGROUND

• 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.

  PMID: 34105718 BACKGROUND

• 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.

  PMID: 37357327 BACKGROUND

• 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.

  PMID: 35489380 BACKGROUND

MeSH Terms

Conditions

Dementia

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Mental Disorders

Study Officials

• Jacqueline Yuen, M.D.

  The University of Hong Kong

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Assistant Professor

Model Details: 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.

Study Record Dates

• First Submitted: June 3, 2024
• First Posted: December 10, 2024
• Study Start: July 23, 2024
• Primary Completion (Estimated): September 30, 2026
• Study Completion (Estimated): September 30, 2026
• Last Updated: December 10, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

HK (1)