Effects of FEED@Home Intervention

Not Applicable

• Conditions: Dementia; Dementia Severe

• Registration Number: NCT06727461
• Lead Sponsor: The University of Hong Kong

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

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.

Study Timeline

• Study First Submitted: 2024-06-03
• Study Start: 2024-07-23
• Status Verified: 2024-12
• Study First Submitted QC: 2024-12-06
• Last Update Submitted: 2024-12-06
• Study First Posted: 2024-12-10
• Last Update Posted: 2024-12-10
• Primary Completion: 2026-09-30
• Study Completion: 2026-09-30

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 180

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Number of unplanned all-cause hospital readmissions	6-month	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.

Secondary Outcome Measures

Name	Time	Method
Number of unplanned all-cause hospital readmissions	1-month, 2-month, and 3-month	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.
Time to first unplanned all-cause hospital readmission	1-month, 2-month, 3-month and 6-month	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.
Number of unplanned feeding-mode related hospital readmissions	1-month, 2-month, 3-month and 6-month	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.
Time to first unplanned feeding mode related hospital readmission	1-month, 2-month, 3-month and 6-month	The time from discharge to the first hospital readmission related to feeding mode will be documented, including the specific date of readmission.
Time to conversion to tube feeding	6-month	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.
Edinburgh Feeding Evaluation in Dementia Questionnaire-Chinese version (C-EdFED-Q)	Baseline, 2-month, and 6-month	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.
Mini Nutritional Assessment-Short Form (MNA-SF)	Baseline, 2-month, 6-month	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)
Quality of Life in Late-Stage Dementia Scale-Chinese version (QUALID-C)	Baseline, 2-month, and 6-month	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.
Satisfaction with Care Questionnaire	Baseline, 2-month, and 6-month	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.
Zarit Burden Interview Scale-Cantonese version (CZBI)	Baseline, 2-month, and 6-month	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

Trial Locations

Locations (1)

Queen Mary Hospital; 🇭🇰 Hong Kong, Hong Kong