UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000043189 |
|---|---|
| Receipt number | R000049293 |
| Scientific Title | Scale development and an educational program to reduce the stigma of schizophrenia among community pharmacists: a randomized controlled trial |
| Date of disclosure of the study information | 2021/01/30 |
| Last modified on | 2021/08/01 13:58:59 |
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Basic information
Public title
Scale development and an educational program to reduce the stigma of schizophrenia among community pharmacists: a randomized controlled trial
Acronym
An educational program to reduce the stigma of schizophrenia among community pharmacists
Scientific Title
Scale development and an educational program to reduce the stigma of schizophrenia among community pharmacists: a randomized controlled trial
Scientific Title:Acronym
An educational program to reduce the stigma of schizophrenia among community pharmacists
Region
| Japan |
Condition
Condition
General population
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study aims to investigate that a combining the educational interventions based on lecture of schizophrenia and communication with patients improve the stigma toward people with schizophrenia among community pharmacists by using a newly developed Stigma Scale towards Schizophrenia for Community Pharmacists
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The amount of change in the degree of stigma for schizophrenia patients before and after intervention by using the Stigma Scale towards Schizophrenia for Community Pharmacists
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
Active
Stratification
YES
Dynamic allocation
Institution consideration
Blocking
YES
Concealment
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Other |
Interventions/Control_1
A 60-minute communicating with patients with schizophrenia and a 60-minute lecture on schizophrenia
Interventions/Control_2
A 60-minute lecture on schizophrenia
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
| 25 | years-old | <= |
Age-upper limit
| 65 | years-old | > |
Gender
Male and Female
Key inclusion criteria
A community pharmacist with over a year of work experience as a pharmacist
Key exclusion criteria
A community pharmacist with less than a year of work experience as a pharmacist
A pharmacist who works outside the insurance pharmacy
Target sample size
120
Research contact person
Name of lead principal investigator
| 1st name | Hiroyuki |
| Middle name | |
| Last name | Kamei |
Organization
Meijo University
Division name
Office of Clinical Pharmacy Practice and Health Care Management, Faculty of Pharmacy
Zip code
468-8503
Address
150 Yagotoyama, Tempaku-ku, Nagoya, Aichi
TEL
052-839-2643
hkamei@meijo-u.ac.jp
Public contact
Name of contact person
| 1st name | Hiroyuki |
| Middle name | |
| Last name | Kamei |
Organization
Meijo University
Division name
Office of Clinical Pharmacy Practice and Health Care Management, Faculty of Pharmacy
Zip code
468-8503
Address
150 Yagotoyama, Tempaku-ku, Nagoya, Aichi
TEL
052-839-2643
Homepage URL
hkamei@meijo-u.ac.jp
Sponsor or person
Institute
Meijo University
Institute
Department
Personal name
Funding Source
Organization
Ministry of Education, Culture, Sports, Science and Technology
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
the Meijo University Research Ethics Board
Address
1-501 Shiogamaguchi, Tempaku-ku, Nagoya, Aichi
Tel
0528382034
souken@ccml.meijo-u.ac.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 | 01 | Month | 30 | Day |
Related information
URL releasing protocol
https://upload.umin.ac.jp/cgi-open-bin/ctr/ctr_view.cgi?recptno=R000049293
Publication of results
Unpublished
Result
URL related to results and publications
https://upload.umin.ac.jp/cgi-bin/icdr/ctr_up_reg_f5.cgi
Number of participants that the trial has enrolled
115
Results
Educational program-related changes of the median (interquartile range) total SSCP score from baseline were -9.0(-16.0- -5.0) in the contact-based intervention group and -3.0(-7.0- 1.0) in the educational lecture group, reflecting a significant reduction of stigma levels in the contact-based intervention group.
Results date posted
| 2021 | Year | 08 | Month | 01 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
115 community pharmacists
Participant flow
Participants were individually allocated to two groups: educational lecture group (56; only attending a lecture on schizophrenia) or contact-based intervention group (59; communicating with patients diagnosed with schizophrenia and attending the lecture).
Adverse events
N/A
Outcome measures
Stigma Scale towards Schizophrenia for Community Pharmacists (SSCP)
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
No longer recruiting
Date of protocol fixation
| 2018 | Year | 06 | Month | 01 | Day |
Date of IRB
| 2018 | Year | 08 | Month | 22 | Day |
Anticipated trial start date
| 2019 | Year | 05 | Month | 13 | Day |
Last follow-up date
| 2020 | 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 | 01 | Month | 30 | Day |
Last modified on
| 2021 | Year | 08 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049293
| Research Plan | |
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| 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 |
