UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000033602 |
|---|---|
| Receipt number | 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 | 2020/02/04 13:46:26 |
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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
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
yhashi@pharm.kobegakuin.ac.jp
Sponsor or person
Institute
Sawa Hospital
Institute
Department
Personal name
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)
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035067
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
