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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04465422
Other study ID # TCHIRB-10904021
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date June 19, 2020
Est. completion date July 16, 2020

Study information

Verified date June 2020
Source Taipei City Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The purpose of the study is to develop and validate Client-centered Occupational Therapy Service at Taipei City Psychiatric Center (OT@tcpc) service model to assist clinicians to provide and integrate comprehensive OT services.


Description:

Occupational Therapy (OT) is one of the mental health services. The service phase includes acute/chronic hospitalization, daycare centers (adolescents, adults, and the elderly), community mental rehabilitation institutions, psychiatric nursing home, and outpatient assessment/treatments. OT provides holistic and continuous mental rehabilitation services at each stage of mental health care. During the acute hospitalization and based on the Model of Human Occupation (MOHO) model, the occupational therapist provides daily activities to assist acute patients with mental illness to develop occupation adaptation to enable and prepare for discharge. However, the lack of a client-centered OT service model limits the interpretation of the treatment effect and the process of change. This will seriously affect the integrity and continuity of OT services and will limit the development of OT professions. Thus, the purpose of the study is to develop and validate Client-centered Occupational Therapy Service at Taipei City Psychiatric Center (OT@tcpc) service model to assist clinicians to provide and integrate comprehensive OT services. This project consists of 2 stages. First, based on the MOHO model we use 5 stages with 6 weeks program to develop the OT@tcpc service model. Second, validate the to indicate the occupation identity and competence to validate the OT@tcpc service model. We will recruit 70 inpatients with schizophrenia and divided into intervention group, based on MOHO theory, and control group.


Recruitment information / eligibility

Status Completed
Enrollment 33
Est. completion date July 16, 2020
Est. primary completion date July 16, 2020
Accepts healthy volunteers No
Gender All
Age group 20 Years to 65 Years
Eligibility Inclusion Criteria: 1. Patients diagnosed with schizophrenia according to DSM-5 diagnostic criteria. 2. Over 20 years old. 3. Agree to participate in the study Exclusion Criteria: - 1. Diagnosis of intellectual developmental disorders 2. History of severe brain injury 3. Cannot complete the study due to poor cognitive, vision or hand function

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Occupational therapy based on the MOHO theory
We selected two acute wards in the Songde hospital as the intervention group and the control group. At the same time, the demographic data of the participants were collected, including gender, age, age of onset, marital status, education level, work experience, etc., and the clinical records, including assessment of mental symptoms and medication records, etc. Continuity or categorical information on Occupational performance, personal and social performance, instrumental activities daily living, and clinical performance. OPHI-II, CGIS, PSP, LIADL, COPM, COTES were tested before and after in the intervention group and the control group to explain the intervention effect of the MOHO theory-based treatment model.
Occupational therapy
The original Occupational therapy. OPHI-II, CGIS, PSP, LIADL, COPM, COTES were tested before and after in the intervention group and the control group to explain the intervention effect of the MOHO theory-based treatment model.

Locations

Country Name City State
Taiwan Taipei City Hospital Taipei

Sponsors (1)

Lead Sponsor Collaborator
Taipei City Hospital

Country where clinical trial is conducted

Taiwan, 

References & Publications (4)

Lee J. Achieving best practice: a review of evidence linked to occupation-focused practice models. Occup Ther Health Care. 2010 Jul;24(3):206-22. doi: 10.3109/07380577.2010.483270. — View Citation

Lee SW, Kielhofner G, Morley M, Heasman D, Garnham M, Willis S, Parkinson S, Forsyth K, Melton J, Taylor RR. Impact of using the Model of Human Occupation: a survey of occupational therapy mental health practitioners' perceptions. Scand J Occup Ther. 2012 Sep;19(5):450-6. doi: 10.3109/11038128.2011.645553. Epub 2012 Jan 3. — View Citation

Lee SW, Taylor R, Kielhofner G, Fisher G. Theory use in practice: a national survey of therapists who use the Model of Human Occupation. Am J Occup Ther. 2008 Jan-Feb;62(1):106-17. — View Citation

Melton J, Forsyth K, Metherall A, Robinson J, Hill J, Quick L. Program Redesign Based on the Model of Human Occupation: Inpatient Services for People Experiencing Acute Mental Illness in the UK. Occup Ther Health Care. 2008;22(2-3):37-50. doi: 10.1080/07380570801989382. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Occupational Performance History Interview-II (OPHI-II) Total and Subscale Scores The Occupational Performance History Interview-Second Version(OPHI-II) was tested before and after in the intervention group and the control group to explain the intervention effect of the MOHO theory-based treatment model.
OPHI-II is a semi-structured interview that gathers life history information. The OPHI-II contains 3 sub-domains: OPHI-II Occupational Identity(range 11~44)?OPHI-II Occupational Competence(range 9~36)?OPHI-II Occupational Behavior Settings(range 9~36).
The three sub-domains are divided into 4 levels, in which 4 points indicate good performance, 3 points indicate good functions, 2 points indicate lack of certain functions, and 1 points indicate poor functions. The total score of OPHI-II is equal to the sum of the three sub-domains (scores 29 to 116; higher scores indicate higher performance).
2 weeks
Secondary Occupational Therapy Evaluation Scales Measure Except for Mini-Menlal State Examination(MMSE), all other tools were tested before and after in the intervention group and the control group to explain the intervention effect of the MOHO theory-based treatment model
The secondary outcome included the following instruments:
Mini-Menlal State Examination, MMSE(range 0~30;the higher scores indicate greater ability)
Canadian Occupational Performance Measure, COPM(performance and satisfaction, each range 1~10;the higher scores indicate greater performance)
Personal and Social Performance scale , PSP(range 1~100;the higher scores indicate greater performance)
Clinical Global Impressions Scale of Severity, CGIS(range 1~7;the lower scores indicate greater performance)
Comprehensive Occupational Therapy Evaluation Scale, COTES(range 20~100;the higher scores indicate greater performance)
Lawton Instrumental Activities Daily Living, LIADL(range 0~23;the higher scores indicate greater performance)
2 weeks
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