UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000060953 |
|---|---|
| Receipt number | R000069753 |
| Scientific Title | Identification of Factors Associated With Psychiatric Readmission and Evaluation of Practice Adjustment Based on These Findings in Day-Care Hospital Users: A Single-Center Two-Phase Study Combining a Retrospective Observational Study and a Prospective Longitudinal Study |
| Date of disclosure of the study information | 2026/03/20 |
| Last modified on | 2026/03/16 20:09:37 |
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Basic information
Public title
Study on Preventing Psychiatric Readmission to Support Community Living in Day-Care Hospital Users
Acronym
Readmission Prevention and Life Support DC Study
Scientific Title
Identification of Factors Associated With Psychiatric Readmission and Evaluation of Practice Adjustment Based on These Findings in Day-Care Hospital Users: A Single-Center Two-Phase Study Combining a Retrospective Observational Study and a Prospective Longitudinal Study
Scientific Title:Acronym
Readmission-Associated Determinants And Response in Day-Care Hospital Study
Region
| Japan |
Condition
Condition
Psychiatry
Classification by specialty
| Psychiatry |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to identify factors associated with psychiatric readmission among users of psychiatric day care and to examine whether organizing and adjusting day care practice and support systems based on these findings may contribute to reducing or preventing readmission. In Study 1, a retrospective observational study will be conducted among users of a psychiatric day care center to identify factors associated with readmission, including daily functioning, subjective recovery, interpersonal difficulties, and service-related characteristics. In Study 2, day care practice organized and adjusted on the basis of the findings from Study 1 will be implemented, and changes in readmission status and related outcomes before and after the intervention will be examined prospectively.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Presence or absence of psychiatric readmission.
The presence or absence of psychiatric readmission during the 1-year period before and the 1-year period after the introduction of adjusted psychiatric day care practice will be assessed. Participants with at least one psychiatric readmission during each period will be classified as yes, and those with no readmission will be classified as no. Assessment will be based on medical records.
Key secondary outcomes
Changes in daily functioning, subjective happiness, subjective recovery, and mental health status
Secondary outcomes will include scores on the Daily Living Functioning Scale (activity domain), the Subjective Happiness Scale (SHS), the Recovery Assessment Scale (RAS), and the 12-item General Health Questionnaire (GHQ-12). These measures will be assessed at baseline and at 1 year after the introduction of adjusted psychiatric day care practice, and changes in scores over time will be examined. Higher scores on the Daily Living Functioning Scale (activity domain), SHS, and RAS indicate better status, whereas higher scores on the GHQ-12 indicate poorer mental health.
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Behavior,custom |
Interventions/Control_1
Intervention
Based on factors associated with psychiatric readmission identified in Study 1, the content and support system of routine psychiatric day care practice will be organized and adjusted. Specifically, the intervention will include support aimed at maintaining and improving daily functioning, individualized support to facilitate continued day care use, and adjustment of the support environment, including outreach support by staff at the study site. The intervention will be delivered by a multidisciplinary team and individually tailored within existing day care programs according to each participant s age, living background, and service use status. The intervention period will be 1 year.
Control
No separate control intervention will be used. Each participant s psychiatric readmission status during the 1 year period before the intervention will be used as a historical control for comparison.
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
| 90 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Participants must meet all of the following criteria:
1) Diagnosed with a psychiatric disorder by the attending physician and receiving treatment for at least 1 year;
2) Aged 20 years or older and younger than 90 years at study entry;
3) Participated in Study 1 and continued to use the psychiatric day care service at the study site after completion of Study 1;
4) Provided written informed consent after receiving a full explanation of the purpose and procedures of the study;
5) Available for follow-up assessment during the study period.
Key exclusion criteria
Participants meeting any of the following criteria will be excluded:
1) Judged by the attending physician to be inappropriate for study participation because of unstable psychiatric condition at study entry;
2) Inability or unwillingness to provide written informed consent for participation in this study;
3) Discontinuation of psychiatric day care use at the study site after completion of Study 1;
4) Judged to be difficult to follow during the study period;
5) Difficulty in collecting the required outcome data during the study period.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Takuya |
| Middle name | |
| Last name | Noguchi |
Organization
Zikei Hospital
Division name
Day-Care Section
Zip code
702-8026
Address
100-2 Urayasu Honmachi Minami ku Okayama shi Okayama Japan
TEL
0862621191
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
day-Care Section
Zip code
702-8026
Address
100-2 Urayasu Honmachi Minami ku Okayama shi Okayama Japan
TEL
0862621191
Homepage URL
ngc_1557_ngc@chic.ocn.ne.jp
Sponsor or person
Institute
Other
Institute
Department
Personal name
Takuya Noguchi
Funding Source
Organization
Noting
Organization
Division
Category of Funding Organization
Non profit foundation
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 shi Okayama Japan
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）
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 03 | Month | 20 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
Result
URL related to results and publications
Number of participants that the trial has enrolled
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
Suspended
Date of protocol fixation
| 2025 | Year | 03 | Month | 01 | Day |
Date of IRB
| 2025 | Year | 02 | Month | 03 | Day |
Anticipated trial start date
| 2025 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2026 | Year | 04 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2026 | Year | 03 | Month | 16 | Day |
Last modified on
| 2026 | Year | 03 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000069753
