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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:
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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Home-based Feeding EnhancEment in Dementia (Feed@home) | Experimental |
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| Control | No Intervention | The patient will receive usual care from the hospital and follow-up care as instructed by the hospital. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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:
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 1-month, 2-month, and 3-month |
| Measure | Description | Time Frame |
|---|---|---|
| Qualitative interview | Approximately 15 to 20 family caregivers who have completed the FEED@home intervention, and the speech therapists and nurses involved in the consultation and home visits will be interviewed to understand their perceptions related to the acceptability, feasibility and experience of the FEED@home intervention. | 6-month |
Subjects are dyads of dementia patients and family caregivers.
Inclusion Criteria (For patients):
Exclusion Criteria(For patients):
Inclusion Criteria (For family caregivers ):
Exclusion Criteria (For family caregivers ): No specific exclusion criteria
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| Name | Affiliation | Role |
|---|---|---|
| Jacqueline Yuen, M.D. | The University of Hong Kong | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Queen Mary Hospital | Hong Kong | Hong Kong |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19828530 | Background | 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. | |
| 25470805 | 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. |
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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.
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| ID | Term |
|---|---|
| D003704 | Dementia |
| ID | Term |
|---|---|
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D019965 | Neurocognitive Disorders |
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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.
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|
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| 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. |
| 1-month, 2-month, 3-month and 6-month |
| 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. | 1-month, 2-month, 3-month and 6-month |
| 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. | 1-month, 2-month, 3-month and 6-month |
| 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. | 6-month |
| 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. | Baseline, 2-month, and 6-month |
| 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) | Baseline, 2-month, 6-month |
| 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. | Baseline, 2-month, and 6-month |
| 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. | Baseline, 2-month, and 6-month |
| 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 | Baseline, 2-month, and 6-month |
| 32059646 | 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. |
| 26504119 | 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. |
| 10527184 | 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. |
| 34387363 | 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. |
| 32736992 | 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. |
| 16708981 | 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. |
| 34105718 | 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. |
| 37357327 | 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. |
| 35489380 | 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. |
| D001523 | Mental Disorders |