Tokyo, March 20 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000060953) titled 'Study on Preventing Psychiatric Readmission to Support Community Living in Day-Care Hospital Users' on March 20.
Study Type:
Interventional
Study Design:
Basic Design - Single arm
Randomization - Non-randomized
Blinding - Open -no one is blinded
Control - Historical
Primary Sponsor:
Institute - Other
Condition:
Condition - Psychiatry
Classification by malignancy - Others
Genomic information - NO
Objective:
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
Intervention:
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.
Eligibility:
Age-lower limit - 20
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 Size - 100
Recruitment Status:
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
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000069753
Disclaimer: Curated by HT Syndication.
