UMIN-CTR Clinical Trial

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	Terminated
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	2019 Year 12 Month 17 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	2020 Year 02 Month 04 Day

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