Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ENROLLING_BY_INVITATION
NA
180 participants
INTERVENTIONAL
2024-07-23
2026-09-30
Brief Summary
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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
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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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
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.
HEALTH_SERVICES_RESEARCH
SINGLE
Study Groups
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Home-based Feeding EnhancEment in Dementia (Feed@home)
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.
Home-based Feeding EnhancEment in Dementia (Feed@home)
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.
Control
The patient will receive usual care from the hospital and follow-up care as instructed by the hospital.
No interventions assigned to this group
Interventions
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Home-based Feeding EnhancEment in Dementia (Feed@home)
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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
* Discharged to residential care homes, respite care or hospice facilities
* No available family caregiver at home
60 Years
ALL
No
Sponsors
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The University of Hong Kong
OTHER
Responsible Party
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YUEN Jacqueline Kwan Yuk
Clinical Assistant Professor
Principal Investigators
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Jacqueline Yuen, M.D.
Role: PRINCIPAL_INVESTIGATOR
The University of Hong Kong
Locations
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Queen Mary Hospital
Hong Kong, , Hong Kong
Countries
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References
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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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Other Identifiers
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21223191
Identifier Type: -
Identifier Source: org_study_id