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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000046073
Receipt No. 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 2021/11/15

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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
Email 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
Email t-higashi@hana-hp.koshokai.or.jp

Sponsor
Institute Aino Hanazono Hospital
Institute
Department

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
Email 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 Preinitiation
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
2021 Year 11 Month 15 Day


Link to view the page
URL(English) https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052583

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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