UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000047015 |
|---|---|
| Receipt number | R000053639 |
| Scientific Title | Examining the effectiveness of positive occupation-based practices using the APO-15 estimation system: A quasi-experimental study |
| Date of disclosure of the study information | 2022/02/26 |
| Last modified on | 2022/11/05 21:39:51 |
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Basic information
Public title
Effectiveness of long-term intervention of positive occupation-based practices that promote well-being: A quasi-experimental validation using the engagement estimation system of assessment of positive occupation-15.
Acronym
Testing the Effectiveness of Occupational Therapy Practices to Promote Well-Being Using the APO-15 Estimation System: A Quasi-Experimental Validation
Scientific Title
Examining the effectiveness of positive occupation-based practices using the APO-15 estimation system: A quasi-experimental study
Scientific Title:Acronym
Effectiveness of POBP using the APO-15 estimation system: a quasi-experimental study
Region
| Japan |
Condition
Condition
Schizophrenia
Classification by specialty
| Psychosomatic Internal Medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study was to quasi-experimentally examine the effects of a long-term intervention of POBP using the APO-15 estimation system in users of occupational therapy in psychiatric daycare and hospitals.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The Positive and Negative Affect Schedule (PANAS)
Assessment period: baseline, post-intervention (after 5 months), post-follow-up (after 1 month)
Key secondary outcomes
1) Assessment of Positive Occupation 15 (APO-15)
2) Subjective Happiness Scale (SHS)
3) Life Assessment Scale for the Mentally Ill (LASMI)
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Behavior,custom |
Interventions/Control_1
The intervention will be conducted by adding positive occupation-based practice (POBP) to the regular occupational therapy program (daycare program) conducted at each facility (5 months). After the intervention, a follow-up period (1 month) is planned to ensure that the effects of the intervention are sustained. The frequency of POBP intervention should be at least once a week.
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1) those who have been diagnosed by a physician as having a psychiatric disorder such as schizophrenia and have been treated for at least one year, 2) those who are between 20 and 80 years of age, 3) those whose evaluation results by the APO-15 estimation system are in the range of rank 1 to 4, 4) those who understand the contents of the study and are able to consent to participation, 5) those whose medical conditions are relatively stable and who are judged to be able to cooperate in this study based on the judgment of their attending physician.
Key exclusion criteria
1) Those whose condition is unstable and who are judged by their attending physician or others to be unable to participate in this study to the end, 2) Those whose age is less than 20 years or more than 81 years, 3) Those whose evaluation result by the APO-15 estimation system is rank 5, 4) Those who do not consent to this study.
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | Takuya |
| Middle name | |
| Last name | Noguchi |
Organization
Zikei Hospital
Division name
Occupational Therapy Section
Zip code
702-8026
Address
100-2, Urayasu Honmachi, Minami-ku, Okayama City, Okayama Prefecture
TEL
086-262-1191
ngc_1557_ngc@chic.ocn.ne.jp
Public contact
Name of contact person
| 1st name | Takuya |
| Middle name | |
| Last name | Noguchi |
Organization
Zikei Hospital
Division name
Occupational Therapy Section
Zip code
702-8026
Address
100-2, Urayasu Honmachi, Minami-ku, Okayama City, Okayama Prefecture
TEL
086-262-1191
Homepage URL
ngc_1557_ngc@chic.ocn.ne.jp
Sponsor or person
Institute
Zikei Hospital
Institute
Department
Personal name
Funding Source
Organization
Japan Association of Occupational Therapists
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Zikei Hospital
Address
100-2, Urayasu Honmachi, Minami-ku, Okayama City, Okayama Prefecture
Tel
086-262-1191
ngc_1557_ngc@chic.ocn.ne.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
慈圭病院（岡山県），河口医院（岡山県），倉敷神経科病院（岡山県），医王ヶ丘病院（石川県），田宮病院（新潟県）
Other administrative information
Date of disclosure of the study information
| 2022 | Year | 02 | Month | 26 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
18
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2022 | Year | 02 | Month | 01 | Day |
Date of IRB
| 2022 | Year | 02 | Month | 01 | Day |
Anticipated trial start date
| 2022 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2022 | Year | 11 | Month | 01 | Day |
Date of closure to data entry
| 2022 | Year | 12 | Month | 01 | Day |
Date trial data considered complete
| 2022 | Year | 12 | Month | 01 | Day |
Date analysis concluded
| 2022 | Year | 12 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2022 | Year | 02 | Month | 26 | Day |
Last modified on
| 2022 | Year | 11 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053639
