UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000050242 |
|---|---|
| Receipt number | R000056968 |
| Scientific Title | Roles of Pharmacy Nurses working in the Pharmacy and their usefulness as a first access function |
| Date of disclosure of the study information | 2023/02/13 |
| Last modified on | 2023/08/07 18:00:43 |
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Basic information
Public title
Research on nursing practice in pharmacies
Acronym
Research on nursing practice in pharmacies
Scientific Title
Roles of Pharmacy Nurses working in the Pharmacy and their usefulness as a first access function
Scientific Title:Acronym
Roles of Pharmacy Nurses working in the Pharmacy and their usefulness as a first access function
Region
| Japan |
Condition
Condition
none
Classification by specialty
| Nursing |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
In this study, actual nursing activities will be conducted at pharmacies in Fukushima Prefecture for residents visiting the pharmacies (here-in-after referred to as "visitors") to verify whether "pharmacy nurses," who are nurses working at pharmacies, can be familiar with and consultative profession for patients and their families who are undergoing medical treatment in the community, as well as for residents who are concerned about their health, and whether they can take on a first-access function that leads to a comprehensive community care system.
Using the nursing role effectiveness model developed based on the Donabedian health care quality assessment theory as a framework, we will investigate the satisfaction of visitors and pharmacy pharmacists as outcomes of nursing activities and clarify the usefulness to the "pharmacy nurse."
Basic objectives2
Others
Basic objectives -Others
In addition, by understanding the overall picture of the activities of the Pharmacy Nurse, the roles of the Pharmacy Nurse and the issues to be addressed will be clarified.
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Pharmacy users' needs and satisfaction
Key secondary outcomes
the satisfaction of Pharmacy pharmacists
Base
Study type
Others,meta-analysis etc
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
People who visit the research cooperating pharmacy during the hours when the nursing staff is active and who have given consent for the study.
Key exclusion criteria
Those who are judged to lack the ability to make decisions about consenting to the research.
Those with significantly impaired cognitive function, who may find it difficult to respond to the questionnaire survey on their own.
Minors.
Target sample size
400
Research contact person
Name of lead principal investigator
| 1st name | Sachiko |
| Middle name | |
| Last name | Sugimoto |
Organization
Fukushima Medical University
Division name
School of Nursing
Zip code
960-1295
Address
1 Hikarigaoka, Fukushima, Fukushima
TEL
0245471111
sugimos@fmu.ac.jp
Public contact
Name of contact person
| 1st name | Sachiko |
| Middle name | |
| Last name | Sugimoto |
Organization
Fukushima Medical University
Division name
School of Nursing
Zip code
960-1295
Address
1 Hikarigaoka, Fukushima, Fukushima
TEL
0245471111
Homepage URL
sugimos@fmu.ac.jp
Sponsor or person
Institute
Fukushima Medical University
Institute
Department
Personal name
Sachiko Sugimoto
Funding Source
Organization
The Japan Society for the Promotion of Science
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
N/A
Address
N/A
Tel
N/A
N/A
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
| 2023 | Year | 02 | Month | 13 | 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
Open public recruiting
Date of protocol fixation
| 2021 | Year | 01 | Month | 19 | Day |
Date of IRB
| 2021 | Year | 01 | Month | 19 | Day |
Anticipated trial start date
| 2023 | Year | 03 | Month | 01 | Day |
Last follow-up date
| 2033 | Year | 02 | Month | 28 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
n/a
Management information
Registered date
| 2023 | Year | 02 | Month | 06 | Day |
Last modified on
| 2023 | Year | 08 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000056968
| 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 |
