UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000046073 |
|---|---|
| Receipt number | R000052583 |
| Scientific Title | Evaluation of team medical care in which nurses and pharmacists propose a treatment plan (Shin team medical care) |
| Date of disclosure of the study information | 2021/12/01 |
| Last modified on | 2022/06/23 16:35:46 |
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Basic information
Public title
Evaluation of team medical care in which nurses and pharmacists propose a treatment plan
(Shin team medical care)
Acronym
Shin team medical care
Scientific Title
Evaluation of team medical care in which nurses and pharmacists propose a treatment plan
(Shin team medical care)
Scientific Title:Acronym
Shin team medical care
Region
| Japan |
Condition
Condition
Schizophrenia
Classification by specialty
| Psychiatry |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
evaluation of team medical care in which nurses and pharmacists propose a treatment plan
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
daily dose of antipsychotics in chlorpromazine equivalents after 6 months of initiation
Key secondary outcomes
Brief Psychiatric Rating Scale
Number of days in physical restraint
after 6 months of initiation
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
team medical care in which nurses and pharmacists propose a treatment plan for six months
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
| 75 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
People with schizophrenia taking three or more antipsychotic medications
Key exclusion criteria
Notihng
Target sample size
5
Research contact person
Name of lead principal investigator
| 1st name | Toru |
| Middle name | |
| Last name | Higashi |
Organization
Aino Hanazono Hospital
Division name
Medical office
Zip code
567-0017
Address
2-6-1 Hanazono, Ibaraki, Osaka
TEL
072-641-4100
t-higashi@hana-hp.koshokai.or.jp
Public contact
Name of contact person
| 1st name | Toru |
| Middle name | |
| Last name | Higashi |
Organization
Aino Hanazono Hospital
Division name
Medical office
Zip code
567-0017
Address
2-6-1 Hanazono, Ibaraki, Osaka
TEL
072-641-4100
Homepage URL
t-higashi@hana-hp.koshokai.or.jp
Sponsor or person
Institute
Aino Hanazono Hospital
Institute
Department
Personal name
Funding Source
Organization
Aino Hanazono Hospital
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Aino Hanazono hospital
Address
2-6-1 Hanazono, Ibaraki, Osaka
Tel
072-641-4100
t-higashi@hana-hp.koshokai.or.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
| 2021 | Year | 12 | Month | 01 | 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
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
Enrolling by invitation
Date of protocol fixation
| 2021 | Year | 10 | Month | 19 | Day |
Date of IRB
| 2021 | Year | 10 | Month | 21 | Day |
Anticipated trial start date
| 2021 | Year | 12 | Month | 01 | Day |
Last follow-up date
| 2023 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2021 | Year | 11 | Month | 15 | Day |
Last modified on
| 2022 | Year | 06 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052583
