NCT04465422

Brief 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
33

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2020

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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 Start

First participant enrolled

June 19, 2020

Completed
18 days until next milestone

First Submitted

Initial submission to the registry

July 7, 2020

Completed
3 days until next milestone

First Posted

Study publicly available on registry

July 10, 2020

Completed
6 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 16, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 16, 2020

Completed
8 months until next milestone

Results Posted

Study results publicly available

March 2, 2021

Completed
Last Updated

March 24, 2021

Status Verified

June 1, 2020

Enrollment Period

27 days

First QC Date

July 7, 2020

Results QC Date

November 15, 2020

Last Update Submit

March 2, 2021

Conditions

Keywords

client-centeredModel of Human Occupation

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Occupational Therapy Evaluation Scales Measure

    2 weeks

Study Arms (2)

Intervention Group

EXPERIMENTAL

We will recruit 70 inpatients with schizophrenia and divided into intervention group and control group. The Intervention group provided Occupational therapy based on the MOHO theory, while the control group adopted the original Occupational therapy model. The research at this stage is based on the theoretical framework of the MOHO model and the clinical practice of OTPF-3. Clinical experts are requested to assist in providing relevant suggestions as a reference for modifying intervention activities. Design OT@tcpc service model for occupational therapy intervention activities. The event design is based on the 4 systems of determinationl, habits, performance and environment, and 2 events are designed for each to be carried out in a group. Each activity includes 4 parts: warm-up, activity, feedback and homework. Each activity group will be explained separately so that the occupational therapist of the group can complete it under the guidance.

Behavioral: Occupational therapy based on the MOHO theory

Control Group

ACTIVE COMPARATOR

We will recruit 70 inpatients with schizophrenia and divided into intervention group and control group. The Intervention group provided Occupational therapy based on the MOHO theory, while the control group adopted the original Occupational therapy model. This study was approved by the Institutional Review Board of Taipei City Hospital. After informed consent, the patients signed the consent form for this study and became the participant of this study. Each activity group will be explained separately so that the participants of each group can complete it under the guidance. The group description includes: activity title, activity time (location), MOHO theory system, group purpose, activity content, equipment or materials, precautions, etc.

Behavioral: Occupational therapy

Interventions

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.

Intervention Group

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.

Control Group

Eligibility Criteria

Age20 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients diagnosed with schizophrenia according to DSM-5 diagnostic criteria.
  • Over 20 years old.
  • Agree to participate in the study

You may not qualify if:

  • \. Diagnosis of intellectual developmental disorders 2. History of severe brain injury 3. Cannot complete the study due to poor cognitive, vision or hand function

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Taipei City Hospital

Taipei, 110209, Taiwan

Location

Related 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.

    PMID: 23898928BACKGROUND
  • 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. doi: 10.5014/ajot.62.1.106.

    PMID: 18254437BACKGROUND
  • 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.

    PMID: 22214401BACKGROUND
  • 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.

    PMID: 23941371BACKGROUND

MeSH Terms

Interventions

Occupational Therapy

Intervention Hierarchy (Ancestors)

RehabilitationAftercareContinuity of Patient CarePatient CareTherapeutics

Results Point of Contact

Title
Shu Chun Lee
Organization
Taipei City Hospital

Study Officials

  • Shu-Chun Lee, Master

    Department of Occupational Therapy

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Masking Details
Participants are blind during this clinical trial. They are prevented from having knowledge of the interventions.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: We will recruit 70 inpatients with schizophrenia and devided into intervention group, based on MOHO theory, and control group.
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 7, 2020

First Posted

July 10, 2020

Study Start

June 19, 2020

Primary Completion

July 16, 2020

Study Completion

July 16, 2020

Last Updated

March 24, 2021

Results First Posted

March 2, 2021

Record last verified: 2020-06

Data Sharing

IPD Sharing
Will not share

Locations