CommunicationNCT07333794
Client Understanding, Expectations, and Intern Performance in Occupational Therapy
An observational study of Communication, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
Trial summary
This study aims to investigate psychiatric clients' understanding of occupational therapy (OT), the reasonableness of their expectations regarding OT services, and OT interns' performance in Occupational Therapy Knowledge (OTK) health education and chief complaint/expectation interviews. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Communication
- What is being tested?
- Clinical Interview and Occupational Therapy Knowledge (OTK) Health Education Session
- How many people
- 139 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Feb 2026to 31 May 2026
- Phase
- Observational
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Psychiatric clients receiving occupational therapy services in the Department of Psychiatry at Kaohsiung Chang Gung Memorial Hospital. Occupational therapy interns completing clinical internships in psychiatric settings. Clinical supervisors who observe and evaluate intern performance during clinical interactions.
Who may be able to join
- Occupational Therapy Students: Currently completing a clinical internship in psychiatric occupational therapy.
- Clinical Supervisors: Willing to participate in the study.
- Psychiatric Clients:
- Age 20 years or older. (2) Diagnosed with a psychiatric disorder according to the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition.
- Able to understand simple questions and follow three-step commands.
Who cannot join
- Occupational Therapy Students: Unwilling to be audio-recorded.
- Clinical Supervisors: No exclusion criteria.
- Psychiatric Clients: Unwilling to be audio-recorded.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Investigating Clients' Understanding and Expectation Reasonableness in Occupational Therapy and Interns' Performance in Health Education and Chief Complaint/Expectation Interviews.
This study aims to investigate psychiatric clients' understanding of occupational therapy (OT), the reasonableness of their expectations regarding OT services, and OT interns' performance in Occupational Therapy Knowledge (OTK) health education and chief complaint/expectation interviews. The project includes developing assessment instruments for client OT knowledge, expectation reasonableness, and intern communication/education performance, followed by data collection in real clinical settings. Clients, clinical supervisors, and external experts will contribute ratings to evaluate instrument validity and reliability. The study will provide foundational evidence for improving OT health education, communication training, and clinical teaching practices.
Read the detailed description
This study examines (1) psychiatric clients' understanding of occupational therapy (OT), (2) the reasonableness of their expectations toward OT, and (3) OT interns' performance in OTK health education and chief complaint/expectation interviews. The project includes instrument development and clinical data collection in the Department of Psychiatry, Kaohsiung Chang Gung Memorial Hospital.
Substudy 1: Client OT Knowledge and Expectation Reasonableness
Substudy 1 consists of two phases. Phase 1 focuses on developing two tools-the OT Knowledge Assessment and the OT Expectation Reasonableness Scale. A team of clinical OT experts and a psychometrics specialist will identify key domains, generate items, and establish scoring guidelines. Content and face validity will be evaluated by external experts and psychiatric clients.
The OT Knowledge Assessment will measure clients' understanding of OT concepts and service scope. The OT Expectation Reasonableness Scale will assess whether clients' expectations for OT processes and outcomes are clinically appropriate.
Phase 2 collects data from psychiatric clients. OT interns will conduct initial interviews exploring clients' chief complaints and expectations. Clients will complete the OT Knowledge Assessment, and both clinical supervisors and external experts will independently evaluate expectation reasonableness using standardized scoring guidelines. Descriptive statistics will summarize clients' knowledge levels and expectation patterns.
Substudy 2: Intern OTK Health Education and Interview Performance
Substudy 2 includes three phases. Phase 1 develops two performance measures: the OTK Health Education Performance Scale and the Chief Complaint/Expectation Interview Performance Scale. Preliminary domains include communication clarity, individualized education, understanding-checking, information-gathering, clarification, and empathy. Expert review will ensure content and face validity.
Phase 2 evaluates 30 OT interns who will conduct initial interviews with psychiatric clients after receiving standardized training. Clinical supervisors will provide real-time ratings, and external experts will score audio recordings and transcripts. Combined evaluations will provide a more comprehensive assessment of intern performance.
Phase 3 examines reliability of the new scales. Inter-rater reliability (supervisors vs. experts) and intra-rater reliability (experts' repeated scoring) will be assessed using weighted Kappa and intraclass correlation coefficients (ICC).
- Conditions
- Communication
- Being tested
- Clinical Interview and Occupational Therapy Knowledge (OTK) Health Education Session
- Keywords
- Health Education, Interview, Occupational Therapy
- Medical subject headings
- Communication, Health Education
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Clinical Interview and Occupational Therapy Knowledge (OTK) Health Education SessionOther
This study involves observational procedures, including: (1) a health education session on occupational therapy knowledge (OTK) delivered by occupational therapy interns, and (2) a semi-structured chief complaint and expectation interview conducted with psychiatric clients by interns. Clinical supervisors and external experts evaluate interns' performance using standardized rating scales, which are developed in this study. No therapeutic or experimental interventions are provided to participants.
| Study group | Role | What they receive |
|---|---|---|
| Psychiatric Clients | Adult psychiatric clients receiving occupational therapy services at the Department of Psychiatry. Receives: Other: Clinical Interview and Occupational Therapy Knowledge (OTK) Health Education Session | |
| Occupational Therapy Interns | OT students completing clinical internships in psychiatry. Receives: Other: Clinical Interview and Occupational Therapy Knowledge (OTK) Health Education Session | |
| Clinical Supervisors | Licensed occupational therapists serving as clinical supervisors. Receives: Other: Clinical Interview and Occupational Therapy Knowledge (OTK) Health Education Session |
What is being measured
The primary outcome is the main question the study is designed to answer.
Occupational Therapy Knowledge Score
Clients' level of understanding of occupational therapy, measured using the Occupational Therapy Knowledge Assessment, which will be developed in this study. Higher scores will indicate greater knowledge of occupational therapy. The score range is not yet finalized.
Measured: Baseline
Occupational Therapy Expectation Reasonableness Score
Clients' expectations regarding occupational therapy processes and outcomes will be evaluated using the Occupational Therapy Expectation Reasonableness Scale, which will be developed in this study. Higher scores will indicate more clinically appropriate expectations. The score range is not yet finalized.
Measured: Baseline
Occupational Therapy Knowledge Health Education Performance Score
Occupational Therapy interns' performance in delivering occupational therapy health education to psychiatric clients will be evaluated using the Occupational Therapy Knowledge Health Education Performance Scale, which will be developed in this study. Higher scores will indicate better performance in delivering health education. The score range is not yet finalized.
Measured: Baseline
Chief Complaint/Expectation Interview Performance Score
Occupational Therapy interns' performance in conducting chief complaint and expectation interviews will be evaluated using the Interview Performance Scale, which will be developed in this study. Higher scores will indicate better interview performance. The score range is not yet finalized.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2026
- Study start1 Feb 2026 (estimated)
- Primary completion1 May 2026 (estimated)
- Study completion31 May 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CommunicationStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 139 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chang Gung Memorial Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07333794
- Sponsor's protocol ID
- 202500540B0
- Status last verified
- Jun 2025
- First submitted
- 24 Dec 2025
- Last updated
- 12 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigating Clients' Understanding and Expectation Reasonableness in Occupational Therapy and Interns' Performance in Health Education and Chief Complaint/Expectation Interviews.
- ClinicalTrials.gov ID
- NCT07333794
- Acronym / sponsor ID
- 202500540B0
- Conditions
- Communication
- Keywords
- Health Education, Interview, Occupational Therapy
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 139 participants (estimated)
- Lead sponsor
- Chang Gung Memorial HospitalUniversity, hospital or other
- Study start
- 1 Feb 2026 (estimated)
- Primary completion
- 1 May 2026 (estimated)
- Study completion
- 31 May 2026 (estimated)
- First posted
- 12 Jan 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.
This study aims to investigate psychiatric clients' understanding of occupational therapy (OT), the reasonableness of their expectations regarding OT services, and OT interns' performance in Occupational Therapy Knowledge (OTK) health education and chief complaint/expectation interviews. The project includes developing assessment instruments for client OT knowledge, expectation reasonableness, and intern communication/education performance, followed by data collection in real clinical settings. Clients, clinical supervisors, and external experts will contribute ratings to evaluate instrument validity and reliability. The study will provide foundational evidence for improving OT health education, communication training, and clinical teaching practices.
Detailed description
This study examines (1) psychiatric clients' understanding of occupational therapy (OT), (2) the reasonableness of their expectations toward OT, and (3) OT interns' performance in OTK health education and chief complaint/expectation interviews. The project includes instrument development and clinical data collection in the Department of Psychiatry, Kaohsiung Chang Gung Memorial Hospital.
Substudy 1: Client OT Knowledge and Expectation Reasonableness
Substudy 1 consists of two phases. Phase 1 focuses on developing two tools-the OT Knowledge Assessment and the OT Expectation Reasonableness Scale. A team of clinical OT experts and a psychometrics specialist will identify key domains, generate items, and establish scoring guidelines. Content and face validity will be evaluated by external experts and psychiatric clients.
The OT Knowledge Assessment will measure clients' understanding of OT concepts and service scope. The OT Expectation Reasonableness Scale will assess whether clients' expectations for OT processes and outcomes are clinically appropriate.
Phase 2 collects data from psychiatric clients. OT interns will conduct initial interviews exploring clients' chief complaints and expectations. Clients will complete the OT Knowledge Assessment, and both clinical supervisors and external experts will independently evaluate expectation reasonableness using standardized scoring guidelines. Descriptive statistics will summarize clients' knowledge levels and expectation patterns.
Substudy 2: Intern OTK Health Education and Interview Performance
Substudy 2 includes three phases. Phase 1 develops two performance measures: the OTK Health Education Performance Scale and the Chief Complaint/Expectation Interview Performance Scale. Preliminary domains include communication clarity, individualized education, understanding-checking, information-gathering, clarification, and empathy. Expert review will ensure content and face validity.
Phase 2 evaluates 30 OT interns who will conduct initial interviews with psychiatric clients after receiving standardized training. Clinical supervisors will provide real-time ratings, and external experts will score audio recordings and transcripts. Combined evaluations will provide a more comprehensive assessment of intern performance.
Phase 3 examines reliability of the new scales. Inter-rater reliability (supervisors vs. experts) and intra-rater reliability (experts' repeated scoring) will be assessed using weighted Kappa and intraclass correlation coefficients (ICC).
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Psychiatric Clients | – | Other: Clinical Interview and Occupational Therapy Knowledge (OTK) Health Education SessionAdult psychiatric clients receiving occupational therapy services at the Department of Psychiatry. |
| Occupational Therapy Interns | – | Other: Clinical Interview and Occupational Therapy Knowledge (OTK) Health Education SessionOT students completing clinical internships in psychiatry. |
| Clinical Supervisors | – | Other: Clinical Interview and Occupational Therapy Knowledge (OTK) Health Education SessionLicensed occupational therapists serving as clinical supervisors. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Psychiatric clients receiving occupational therapy services in the Department of Psychiatry at Kaohsiung Chang Gung Memorial Hospital. Occupational therapy interns completing clinical internships in psychiatric settings. Clinical supervisors who observe and evaluate intern performance during clinical interactions.
Key inclusion criteria (5 listed)
- Occupational Therapy Students: Currently completing a clinical internship in psychiatric occupational therapy.
- Clinical Supervisors: Willing to participate in the study.
- Psychiatric Clients:
- Age 20 years or older. (2) Diagnosed with a psychiatric disorder according to the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition.
- Able to understand simple questions and follow three-step commands.
Key exclusion criteria (3 listed)
- Occupational Therapy Students: Unwilling to be audio-recorded.
- Clinical Supervisors: No exclusion criteria.
- Psychiatric Clients: Unwilling to be audio-recorded.
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 |
|---|---|---|
| Clinical Interview and Occupational Therapy Knowledge (OTK) Health Education SessionThis study involves observational procedures, including: (1) a health education session on occupational therapy knowledge (OTK) delivered by occupational therapy interns, and (2) a semi-structured chief complaint and expectation interview conducted with psychiatric clients by interns. Clinical supervisors and external experts evaluate interns' performance using standardized rating scales, which are developed in this study. No therapeutic or experimental interventions are provided to participants. | Other | Clinical Supervisors, Occupational Therapy Interns, Psychiatric Clients |
Primary outcome
Occupational Therapy Knowledge Score
Time frame: Baseline
Clients' level of understanding of occupational therapy, measured using the Occupational Therapy Knowledge Assessment, which will be developed in this study. Higher scores will indicate greater knowledge of occupational therapy. The score range is not yet finalized.
Occupational Therapy Expectation Reasonableness Score
Time frame: Baseline
Clients' expectations regarding occupational therapy processes and outcomes will be evaluated using the Occupational Therapy Expectation Reasonableness Scale, which will be developed in this study. Higher scores will indicate more clinically appropriate expectations. The score range is not yet finalized.
Occupational Therapy Knowledge Health Education Performance Score
Time frame: Baseline
Occupational Therapy interns' performance in delivering occupational therapy health education to psychiatric clients will be evaluated using the Occupational Therapy Knowledge Health Education Performance Scale, which will be developed in this study. Higher scores will indicate better performance in delivering health education. The score range is not yet finalized.
Chief Complaint/Expectation Interview Performance Score
Time frame: Baseline
Occupational Therapy interns' performance in conducting chief complaint and expectation interviews will be evaluated using the Interview Performance Scale, which will be developed in this study. Higher scores will indicate better interview performance. The score range is not yet finalized.
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 12 Jan 2026.
- 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?
An observational study of Communication, 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 5 inclusion and 3 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: opening soon, as of the sponsor's last update on 12 Jan 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 HUNG-FEI WU (886-7-7317123 ext. 8766, feifei@cgmh.org.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Occupational Therapy Knowledge Score (time frame: Baseline). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 12 Jan 2026.