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Enrolling by Invitation

NCT Number: NCT06727461

Effects of FEED@Home Intervention

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

Enrolling by Invitation

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Key information

Conditions

Dementia Brain Diseases Central Nervous System Diseases Dementia Severe Mental Disorders Nervous System Diseases Neurocognitive Disorders

Age range

60 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Queen Mary Hospital

Hong Kong

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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:

  • 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

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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. 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.

  7. 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)

  8. 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.

  9. 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.

  10. 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

Other outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

The University of Hong Kong

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Dec 10, 2024
Registry last updated
Dec 10, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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