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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000033602
Receipt No. R000035067
Scientific Title Usefulness of home-visit nursing by pharmacist on prevention of re-hospitalization in patients with mental disorder: an interventional pre / post study
Date of disclosure of the study information 2018/09/01
Last modified on 2019/08/03

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Basic information
Public title Usefulness of home-visit nursing by pharmacist on prevention of re-hospitalization in patients with mental disorder: an interventional pre / post study
Acronym Home-visit nursing by pharmacists can prevent patients from re-hospitalization
Scientific Title Usefulness of home-visit nursing by pharmacist on prevention of re-hospitalization in patients with mental disorder: an interventional pre / post study
Scientific Title:Acronym Home-visit nursing by pharmacists can prevent patients from re-hospitalization
Region
Japan

Condition
Condition patients with metal disorder
Classification by specialty
Psychosomatic Internal Medicine Psychiatry
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To clarify the usefulness of pharmacists to prevent patients with mental disorder from re-hospitalization
Basic objectives2 Others
Basic objectives -Others To confirm whether home-visit nursing by pharmacists affects patient's QOL and psychiatric symptoms.
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes rate of re-hospitalization (6 months after starting intervention)
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Other
Interventions/Control_1 Home-visit nursing by pharmacists (6 months, at least once a month)
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
80 years-old >=
Gender Male and Female
Key inclusion criteria Inclusion criteria are as follows;
1) visiting to Sawa hospital regularly
2) multiple hospitalization in the past two years
Key exclusion criteria Exclusion criteria are patients with dementia, mental retardation, or personality disorders.
Target sample size 26

Research contact person
Name of lead principal investigator
1st name Yasuhiko
Middle name
Last name Hashimoto
Organization Sawa Hospital
Division name Department of Pharmacy
Zip code 561-0803
Address 1-9-1 shiroyama-chou, toyonaka Osaka
TEL 06-6865-1211
Email yhashi@pharm.kobegakuin.ac.jp

Public contact
Name of contact person
1st name Yasuhiko
Middle name
Last name Hashimoto
Organization Sawa Hospital
Division name Department of Pharmacy
Zip code 561-0803
Address 1-9-1 shiroyama-chou, toyonaka Osaka
TEL 06-6865-1211
Homepage URL
Email yhashi@pharm.kobegakuin.ac.jp

Sponsor
Institute Sawa Hospital
Institute
Department

Funding Source
Organization self funding
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 Sawa Hospital
Address 1-9-1 Shirayamacho, Toyonaka, Osaka
Tel 06-6865-1211(7610)
Email clin-res@hokuto-kai.com

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 さわ病院(大阪府)、神戸学院大学(兵庫県)

Other administrative information
Date of disclosure of the study information
2018 Year 09 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
2017 Year 07 Month 25 Day
Date of IRB
2017 Year 08 Month 15 Day
Anticipated trial start date
2017 Year 08 Month 01 Day
Last follow-up date
2022 Year 07 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
2018 Year 08 Month 02 Day
Last modified on
2019 Year 08 Month 03 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035067

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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