NCT07384481

Brief Summary

Background: As Taiwan faces an aging population, the demand for long- term care services continues to rise, increasing the need for skilled care workers. Care Food Specialists, focusing on food preparation and oral health in long-term care, are essential for improving care quality. Objective: This project aims to develop a core competency training curriculum for Care Food Specialists in Taiwan and assess its effectiveness in enhancing care worker skills. Methods: Over two years, participants were recruited from various regions for training, with pre- and post-course assessments and qualitative interviews to evaluate changes in knowledge, attitude, and behavior. Conclusion/Practical Applications: The project successfully designed and implemented a training curriculum, providing evidence of its positive impact on long-term care quality and offering a practical framework for future competency-based training.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
150

participants targeted

Target at P75+ for not_applicable healthy

Timeline
15mo left

Started Aug 2025

Typical duration for not_applicable healthy

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress38%
Aug 2025Jul 2027

Study Start

First participant enrolled

August 1, 2025

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

November 18, 2025

Completed
3 months until next milestone

First Posted

Study publicly available on registry

February 3, 2026

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2027

Last Updated

February 3, 2026

Status Verified

August 1, 2025

Enrollment Period

2 years

First QC Date

November 18, 2025

Last Update Submit

January 29, 2026

Conditions

Keywords

Entrusted Professional Activities

Outcome Measures

Primary Outcomes (1)

  • Eating Support for Healthcare Aides (ESHA) Questionnaire

    The scale is designed to assess caregivers' knowledge, attitudes, and behaviors regarding feeding and swallowing care. It was developed by Lin and Liu (2025) through literature review, expert Delphi consultation, and empirical testing, and comprises three domains with a total of 47 items. The knowledge domain includes 25 dichotomous items (correct/incorrect), with 1 point awarded for a correct answer and 0 points for an incorrect one; higher scores indicate more comprehensive knowledge. The reliability of this domain was examined using the KR-20 coefficient, yielding a value of 0.61. Item difficulty ranged from 0.60 to 0.99, and items demonstrated good discrimination, making the domain suitable as a baseline for comparing pre- and post-intervention educational outcomes. The attitudes and behaviors domains are assessed using a 5-point Likert scale, measuring caregivers' endorsement of feeding support and the frequency of its actual implementation, respectively.

    Baseline, Immediately after the 20-hour intervention course

Study Arms (3)

Student Immediate Intervention Group (IG):

EXPERIMENTAL

Students participated in the Core Competency Training Course for Eating Support Healthcare Aides, a 20-hour program designed to enhance knowledge and skills in providing safe and effective feeding support.

Other: Core Competency Training Course for Eating Support Healthcare Aides (20-Hour Course)

Student Waitlist Control Group (WG)

ACTIVE COMPARATOR

Student Waitlist Control Group (WG) Intervention: Participants in the Student Waitlist Control Group (WG) initially do not receive any training during the primary study period, serving as a delayed intervention control to account for time-related and external factors. After completion of all baseline and post-assessment measurements for the immediate intervention group (IG), the waitlist students then receive the same 20-hour Core Competency Training Course as the IG.

Other: Core Competency Training Course for Eating Support Healthcare Aides (20-Hour Course)

Industry Group (RG)

ACTIVE COMPARATOR

Industry Group (RG) Intervention: Participants in the Industry Group (RG) are current professional healthcare aides who receive the 20-hour Core Competency Training Course concurrently with the Student Immediate Intervention Group (IG). The timing ensures that the training is delivered during the same study period as the student intervention, allowing direct comparison of learning outcomes between students and experienced professionals.

Other: Core Competency Training Course for Eating Support Healthcare Aides (20-Hour Course)

Interventions

Core Competency Training Course for Eating Support Healthcare Aides, a 20-hour program designed to enhance knowledge and skills in providing safe and effective feeding support. The course comprised the following modules: 1. Oral Changes and Basic Care Concepts (2 hours) 2. Assisting Clients with Safe Eating (2 hours) 3. Oral Hygiene and Care (3 hours, including practical skills) 4. Dysphagia Diet Standards and Meal Texture Modification (2 hours) 5. Food Storage, Cleaning, and Pre-/Mid-Processing (3 hours) 6. Client Nutrition Knowledge (3 hours) 7. Soft Food Selection and Preparation for Clients with Chewing Difficulties (2 hours) 8. Hands-on Soft Food Preparation and Selection for Clients with Chewing Difficulties (3 hours)

Industry Group (RG)Student Immediate Intervention Group (IG):Student Waitlist Control Group (WG)

Eligibility Criteria

Age19 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Enrolled in a long-term care-related educational program (either a five-year junior college program or a four-year technical program).
  • In the year immediately preceding graduation (fifth-year junior college students or third-year technical program students).
  • Aged 19 years or older.
  • Had completed the Basic Care Practice and Laboratory course.
  • Able to attend the full 20-hour training course.

You may not qualify if:

  • Unwilling to participate or unable to complete the full 20-hour course (e.g., due to other academic commitments)
  • Industry Healthcare Aide Group
  • Currently employed as a professional healthcare aide in community-based or institutional long-term care settings.
  • Actively working in a care aide role with at least one year of relevant experience.
  • Possess a valid Taiwan Care Worker Training Certificate.
  • Aged 20 years or older.
  • Able to communicate in both Mandarin and Taiwanese.
  • Able to attend the full 20-hour training course.
  • Younger than 20 years of age.
  • Unable to communicate in Mandarin and Taiwanese.
  • Not currently employed as a community or institutional care aide.
  • Unable to complete the full 20-hour course

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chang Gung Medical Foundation

Tainan, Taiwan, 721, Taiwan

RECRUITING

Related Publications (4)

  • Waldron C, Nunn J, Mac Giolla Phadraig C, Comiskey C, Guerin S, van Harten MT, Donnelly-Swift E, Clarke MJ. Oral hygiene interventions for people with intellectual disabilities. Cochrane Database Syst Rev. 2019 May 31;5(5):CD012628. doi: 10.1002/14651858.CD012628.pub2.

    PMID: 31149734BACKGROUND
  • Newman R, Vilardell N, Clave P, Speyer R. Effect of Bolus Viscosity on the Safety and Efficacy of Swallowing and the Kinematics of the Swallow Response in Patients with Oropharyngeal Dysphagia: White Paper by the European Society for Swallowing Disorders (ESSD). Dysphagia. 2016 Apr;31(2):232-49. doi: 10.1007/s00455-016-9696-8. Epub 2016 Mar 25.

    PMID: 27016216BACKGROUND
  • Chen S, Kent B, Cui Y. Interventions to prevent aspiration in older adults with dysphagia living in nursing homes: a scoping review. BMC Geriatr. 2021 Jul 17;21(1):429. doi: 10.1186/s12877-021-02366-9.

    PMID: 34273953BACKGROUND
  • Lin CH, Liu MY. Development and Validation of the Eating Support for Healthcare Aides (ESHA) Questionnaire in Long-Term Care. Nutrients. 2025 Oct 15;17(20):3235. doi: 10.3390/nu17203235.

    PMID: 41156487BACKGROUND

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
OTHER
Intervention Model
CROSSOVER
Model Details: hree-arm waitlist control trial (WCT) design
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 18, 2025

First Posted

February 3, 2026

Study Start

August 1, 2025

Primary Completion (Estimated)

July 31, 2027

Study Completion (Estimated)

July 31, 2027

Last Updated

February 3, 2026

Record last verified: 2025-08

Data Sharing

IPD Sharing
Will not share

Locations