HealthyNCT07384481
Building Core Competencies of Taiwanese Care Food Specialists: Curriculum Design and Outcome Assessment
A study testing Core Competency Training Course for Eating Support Healthcare Aides (20-Hour Course) in people with Healthy, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
Trial 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. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Healthy
- What is being tested?
- Core Competency Training Course for Eating Support Healthcare Aides (20-Hour Course)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Aug 2025to 31 Jul 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Unwilling to participate or unable to complete the full 20-hour course (e.g., due to other academic commitments)
- Industry Healthcare Aide Group
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Taiwan1 site, 1 recruiting
- Recruiting
Chang Gung Medical Foundation
Tainan, Taiwan, 721
CHIAHUI LIN, +886-0912749610, clh9031@gmail.com
chiahui Lin
About this study
Official title: Nursing Department Assistant Professor
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.
Read more
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.
Read the detailed description
This study aims to evaluate the effectiveness of a Core Competency Training Course for Eating Support Healthcare Aides on knowledge and skills related to safe feeding practices, oral care, dysphagia diet management, and nutrition support for individuals with chewing or swallowing difficulties. The study employs a three-arm waitlist control trial (WCT) design, including both students and industry professionals, to comprehensively assess learning outcomes across different participant populations.
Study Design and Groups:
Participants are assigned to one of three groups:
- Student Immediate Intervention Group (IG): Students receive the 20-hour training program at the beginning of the study.
- Student Waitlist Control Group (WG): Students receive the same training after the initial study period, serving as a delayed intervention control.
- Industry Group (RG): Current professional healthcare aides who receive the training concurrently with the student immediate intervention group.
This design allows comparison of pre- and post-intervention changes in the student immediate group, assessment of delayed intervention effects in the waitlist group, and evaluation of differences between students and industry professionals.
Participant Recruitment:
Student Group: Fifth-year junior college and third-year technical program students in long-term care-related programs, aged 19 years or older, who have completed a "Basic Care Practice and Laboratory" course and are able to attend the full 20-hour training. Students who are unwilling or have prior swallowing-related training are excluded.
Industry Group: Current professional healthcare aides aged 20 years or older with at least one year of experience in community or institutional long-term care settings, able to communicate in Mandarin and Taiwanese, and able to attend the full 20-hour course. Exclusion criteria include non-current employment, lack of language proficiency, or inability to complete the training.
Intervention (Training Program): The 20-hour Core Competency Training Course
Outcomes and Evaluation:
Participants' knowledge, practical skills, and competence in safe feeding and nutrition support are assessed pre- and post-intervention. Comparisons among groups allow evaluation of the training's immediate effects, delayed intervention impact, and differences between students and experienced professionals.
This comprehensive study design ensures both rigorous evaluation of the intervention's effectiveness and ethical inclusion of all student participants while providing practical insights for improving long-term care training programs.
- Conditions
- Healthy
- Being tested
- Core Competency Training Course for Eating Support Healthcare Aides (20-Hour Course)
- Keywords
- Entrusted Professional Activities
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Core Competency Training Course for Eating Support Healthcare Aides (20-Hour Course)Other
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:
- Oral Changes and Basic Care Concepts (2 hours)
- Assisting Clients with Safe Eating (2 hours)
- Oral Hygiene and Care (3 hours, including practical skills)
- Dysphagia Diet Standards and Meal Texture Modification (2 hours)
- Food Storage, Cleaning, and Pre-/Mid-Processing (3 hours)
- Client Nutrition Knowledge (3 hours)
- Soft Food Selection and Preparation for Clients with Chewing Difficulties (2 hours)
- Hands-on Soft Food Preparation and Selection for Clients with Chewing Difficulties (3 hours)
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: Other: Core Competency Training Course for Eating Support Healthcare Aides (20-Hour Course) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline, Immediately after the 20-hour intervention course, and 30 days post-intervention.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2026
- Study start1 Aug 2025
- Primary completion31 Jul 2027 (estimated)
- Study completion31 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by Chang Gung Memorial HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Model description
- hree-arm waitlist control trial (WCT) design
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chang Gung Memorial Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- National Science and Technology Council, Taiwan
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07384481
- Sponsor's protocol ID
- linchiahui
- Status last verified
- Oct 2026
- First submitted
- 18 Nov 2025
- Last updated
- 22 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 31149734Newman 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.
PubMed 27016216Chen 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.
PubMed 34273953Lin 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.
PubMed 41156487
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nursing Department Assistant Professor
- ClinicalTrials.gov ID
- NCT07384481
- Acronym / sponsor ID
- linchiahui
- Conditions
- Healthy
- Keywords
- Entrusted Professional Activities
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Chang Gung Memorial HospitalUniversity, hospital or other
- Collaborators
- National Science and Technology Council, Taiwan
- Study start
- 1 Aug 2025 (actual)
- Primary completion
- 31 Jul 2027 (estimated)
- Study completion
- 31 Jul 2027 (estimated)
- First posted
- 3 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This study aims to evaluate the effectiveness of a Core Competency Training Course for Eating Support Healthcare Aides on knowledge and skills related to safe feeding practices, oral care, dysphagia diet management, and nutrition support for individuals with chewing or swallowing difficulties. The study employs a three-arm waitlist control trial (WCT) design, including both students and industry professionals, to comprehensively assess learning outcomes across different participant populations.
Study Design and Groups:
Participants are assigned to one of three groups:
- Student Immediate Intervention Group (IG): Students receive the 20-hour training program at the beginning of the study.
- Student Waitlist Control Group (WG): Students receive the same training after the initial study period, serving as a delayed intervention control.
- Industry Group (RG): Current professional healthcare aides who receive the training concurrently with the student immediate intervention group.
This design allows comparison of pre- and post-intervention changes in the student immediate group, assessment of delayed intervention effects in the waitlist group, and evaluation of differences between students and industry professionals.
Participant Recruitment:
Student Group: Fifth-year junior college and third-year technical program students in long-term care-related programs, aged 19 years or older, who have completed a "Basic Care Practice and Laboratory" course and are able to attend the full 20-hour training. Students who are unwilling or have prior swallowing-related training are excluded.
Industry Group: Current professional healthcare aides aged 20 years or older with at least one year of experience in community or institutional long-term care settings, able to communicate in Mandarin and Taiwanese, and able to attend the full 20-hour course. Exclusion criteria include non-current employment, lack of language proficiency, or inability to complete the training.
Intervention (Training Program): The 20-hour Core Competency Training Course
Outcomes and Evaluation:
Participants' knowledge, practical skills, and competence in safe feeding and nutrition support are assessed pre- and post-intervention. Comparisons among groups allow evaluation of the training's immediate effects, delayed intervention impact, and differences between students and experienced professionals.
This comprehensive study design ensures both rigorous evaluation of the intervention's effectiveness and ethical inclusion of all student participants while providing practical insights for improving long-term care training programs.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
- Model description
- hree-arm waitlist control trial (WCT) design
| Arm | Type | Receives |
|---|---|---|
| Student Immediate Intervention Group (IG): | Experimental | Other: Core Competency Training Course for Eating Support Healthcare Aides (20-Hour Course)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. |
| Student Waitlist Control Group (WG) | Active comparator | Other: Core Competency Training Course for Eating Support Healthcare Aides (20-Hour Course)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. |
| Industry Group (RG) | Active comparator | Other: Core Competency Training Course for Eating Support Healthcare Aides (20-Hour Course)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. |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (6 listed)
- Unwilling to participate or unable to complete the full 20-hour course (e.g., due to other academic commitments)
- Industry Healthcare Aide Group
- Younger than 20 years of age.
- Unable to communicate in Mandarin and Taiwanese.
- Not currently employed as a community or institutional care aide.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Core Competency Training Course for Eating Support Healthcare Aides (20-Hour Course)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) | Other | Industry Group (RG), Student Immediate Intervention Group (IG):, Student Waitlist Control Group (WG) |
Primary outcome
Eating Support for Healthcare Aides (ESHA) Questionnaire
Time frame: Baseline, Immediately after the 20-hour intervention course, and 30 days post-intervention.
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Oct 2026.
- Background: PubMed 31149734Waldron 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.
- Background: PubMed 27016216Newman 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.
- Background: PubMed 34273953Chen 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.
- Background: PubMed 41156487Lin 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Core Competency Training Course for Eating Support Healthcare Aides (20-Hour Course) in people with Healthy, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 22 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact ChiaHui Lin (+886-912748610, clh9031@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Eating Support for Healthcare Aides (ESHA) Questionnaire (time frame: Baseline, Immediately after the 20-hour intervention course, and 30 days post-intervention.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07384481, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Oct 2026.