UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000055158 |
|---|---|
| Receipt number | R000062987 |
| Scientific Title | Survey on the proportion of alcohol-dependent patients receiving outpatient treatment in the early stages of treatment and the actual status of treatment using claims data in Japan |
| Date of disclosure of the study information | 2024/12/01 |
| Last modified on | 2024/08/01 17:39:38 |
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Basic information
Public title
Survey on the proportion of alcohol-dependent patients receiving outpatient treatment in the early stages of treatment and the actual status of treatment using claims data in Japan
Acronym
Survey on the proportion of alcohol-dependent patients receiving outpatient treatment in the early stages of treatment and the actual status of treatment using claims data in Japan
Scientific Title
Survey on the proportion of alcohol-dependent patients receiving outpatient treatment in the early stages of treatment and the actual status of treatment using claims data in Japan
Scientific Title:Acronym
Survey on the proportion of alcohol-dependent patients receiving outpatient treatment in the early stages of treatment and the actual status of treatment using claims data in Japan
Region
| Japan |
Condition
Condition
Alcohol Dependence
Classification by specialty
| Medicine in general | Psychosomatic Internal Medicine | Psychiatry |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To describe the proportion of alcohol-dependent patients undergoing outpatient treatment in the early stages of treatment after being diagnosed with alcohol dependence
To explore factors that influence continuation of outpatient treatment for alcohol dependence
To investigate the actual status of treatment for 1 year prior and 1 year after the diagnosis of alcohol dependence
Basic objectives2
Others
Basic objectives -Others
To investigate the treatment patterns of alcohol-dependent patients in the year before and the year after diagnosis of alcohol dependence, and treatment for alcohol dependence these patients received in the year following diagnosis
Trial characteristics_1
Others
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
Outpatient treatment continuation rate
Key secondary outcomes
Prevalence of comorbidities before and after the initial diagnosis of alcohol dependence
Prescription rate of medications in the year before and after the initial diagnosis of alcohol dependence (medications for alcohol dependence, nicotine dependence, anti-anxiety drugs, sleep and sedative drugs, painkillers, antidepressants, schizophrenia drugs, mood stabilizers, anti-epileptics, etc.)
Implementation rate of psychosocial therapy in the year before and after the initial diagnosis of alcohol dependence, etc.
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients diagnosed with "ICD-10 Code: F10.2 Mental and behavioral disorders due to use of alcohol Dependence syndrome" during the enrollment period.
Key exclusion criteria
Patients under 20 years old
Patients who were diagnosed with "ICD-10 Code: F10.2 Mental and behavioral disorders due to use of alcohol Dependence syndrome" within one year prior to their first diagnosis of alcohol dependence during the enrollment period
Patients who were only suspected of having "ICD-10 Code: F10.2 Mental and behavioral disorders due to use of alcohol Dependence syndrome" within one year after their first diagnosis of alcohol dependence during the enrollment period
Patients whose health insurance enrollment period was less than one year prior to their first diagnosis of alcohol dependence during the enrollment period
Patients whose health insurance enrollment period was less than one year after their first diagnosis of alcohol dependence during the enrollment period
Target sample size
2101
Research contact person
Name of lead principal investigator
| 1st name | Yoshitsugu |
| Middle name | |
| Last name | Kojima |
Organization
Otsuka Pharmaceutical Co., Ltd.
Division name
Medical Affairs
Zip code
108-8242
Address
Shinagawa Grand Central Tower 2-16-4 Konan,Minato-ku, Tokyo 108-8242, Japan
TEL
03-6717-1400
kojimayo@otsuka.jp
Public contact
Name of contact person
| 1st name | Yoshitsugu |
| Middle name | |
| Last name | Kojima |
Organization
Otsuka Pharmaceutical Co.,Ltd.
Division name
Medical Affairs
Zip code
108-8241
Address
Medical Affairs
TEL
03-6717-1400
Homepage URL
kojimayo@otsuka.jp
Sponsor or person
Institute
Otsuka Pharmaceutical Co.,Ltd.
Institute
Department
Personal name
Funding Source
Organization
Otsuka Pharmaceutical Co.,Ltd.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Otsuka Pharmaceutical Co.,Ltd. Research Department Research Ethics Committee
Address
10-463 Kagasuno Kawachi cho Tokushima city Tokushima
Tel
088-665-2126
Suzuki.Takashi@otsuka.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
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 12 | Month | 01 | Day |
Related information
URL releasing protocol
Unpublished
Publication of results
Unpublished
Result
URL related to results and publications
Unpublished
Number of participants that the trial has enrolled
2101
Results
The number of subjects analyzed in this study was 2101. 77.2% of the patients received treatment for alcohol dependence (either a prescription for alcohol dependence medication or at least two instances of psychosocial therapy) after their initial diagnosis. Furthermore, 49.5% of the patients had no record of hospitalization in the year following the initial diagnosis, and of these, 67.7% had records of alcohol dependence treatment extending beyond the first six months post-diagnosis.
Results date posted
| 2024 | Year | 08 | Month | 01 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Of the 2101 patients analyzed, 80.3% were male and 19.7% were female. The mean age (standard deviation) of the patients was 48.8 (10.3) years for males and 44.3 (9.8) years for females.
Participant flow
Out of 6117 patients diagnosed with alcohol dependence during the target period, 2101 met the eligibility criteria, being patients diagnosed with alcohol dependence for the first time (those without a diagnosis of alcohol dependence for at least one year).
Adverse events
Not applicable
Outcome measures
Outpatinets treatment continuation rate
Prevalence of comorbidities before and after the initial diagnosis of alcohol dependence
Prescription rate of medications in the year before and after the initial diagnosis of alcohol dependence (medications for alcohol dependence, nicotine dependence, anti-anxiety drugs, sleep and sedative drugs, painkillers, antidepressants, schizophrenia drugs, mood stabilizers, anti-epileptics, etc.)
Implementation rate of psychosocial therapy in the year before and after the initial diagnosis of alcohol dependence, etc.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2022 | Year | 10 | Month | 28 | Day |
Date of IRB
| 2022 | Year | 12 | Month | 07 | Day |
Anticipated trial start date
| 2023 | Year | 02 | Month | 27 | Day |
Last follow-up date
| 2023 | Year | 07 | Month | 06 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2023 | Year | 09 | Month | 07 | Day |
Other
Other related information
Factors influencing the duration until discontinuation of outpatient treatment for patients who initiated such therapy, including gender, age, presence of comorbidities, presence of mental disorders, presence of liver diseases, and health insurance classification, are assessed using Cox regression.
Management information
Registered date
| 2024 | Year | 08 | Month | 05 | Day |
Last modified on
| 2024 | Year | 08 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000062987
