Effects of FEED@Home Intervention

December 6, 2024 updated by: YUEN Jacqueline Kwan Yuk, The University of Hong Kong

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

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

Study Overview

Status

Enrolling by invitation

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

180

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Hong Kong
      • Hong Kong, Hong Kong
        • Queen Mary Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Other: 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 Names:
  • Feed@home program
No Intervention: Control
The patient will receive usual care from the hospital and follow-up care as instructed by the hospital.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of unplanned all-cause hospital readmissions
Time Frame: 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.
6-month

Secondary Outcome Measures

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

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Qualitative interview
Time Frame: 6-month
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The University of Hong Kong

Investigators

  • Principal Investigator: Jacqueline Yuen, M.D., The University of Hong Kong

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 23, 2024

Primary Completion (Estimated)

September 30, 2026

Study Completion (Estimated)

September 30, 2026

Study Registration Dates

First Submitted

June 3, 2024

First Submitted That Met QC Criteria

December 6, 2024

First Posted (Estimated)

December 10, 2024

Study Record Updates

Last Update Posted (Estimated)

December 10, 2024

Last Update Submitted That Met QC Criteria

December 6, 2024

Last Verified

December 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 21223191

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

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.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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