Effects of FEED@Home Intervention

Официальное название

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

Обзор

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

Подробное описание

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.

Вмешательства

• Другое 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 tailo

Первичные конечные точки

• Number of unplanned all-cause hospital readmissions [Срок оценки: 6-month]

Вторичные конечные точки (10)

• Number of unplanned all-cause hospital readmissions [Срок оценки: 1-month, 2-month, and 3-month]
• Time to first unplanned all-cause hospital readmission [Срок оценки: 1-month, 2-month, 3-month and 6-month]
• Number of unplanned feeding-mode related hospital readmissions [Срок оценки: 1-month, 2-month, 3-month and 6-month]
• Time to first unplanned feeding mode related hospital readmission [Срок оценки: 1-month, 2-month, 3-month and 6-month]
• Time to conversion to tube feeding [Срок оценки: 6-month]
• Edinburgh Feeding Evaluation in Dementia Questionnaire-Chinese version (C-EdFED-Q) [Срок оценки: Baseline, 2-month, and 6-month]
• Mini Nutritional Assessment-Short Form (MNA-SF) [Срок оценки: Baseline, 2-month, 6-month]
• Quality of Life in Late-Stage Dementia Scale-Chinese version (QUALID-C) [Срок оценки: Baseline, 2-month, and 6-month]
• Satisfaction with Care Questionnaire [Срок оценки: Baseline, 2-month, and 6-month]
• Zarit Burden Interview Scale-Cantonese version (CZBI) [Срок оценки: Baseline, 2-month, and 6-month]

Критерии участия

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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Организация здравоохранения

Центры проведения

Гонконг · 1 центр

• Queen Mary Hospital — Гонконг

Публикации

• 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
• 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
• 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
• 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
• 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
• 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
• 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
• 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

Идентификаторы

NCT: NCT06727461 · 21223191

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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