UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000051057 |
|---|---|
| Receipt number | R000058219 |
| Scientific Title | Research on Effective Follow-up Procedures During the Medication Period - Utilization of Tracing Report Template - |
| Date of disclosure of the study information | 2023/05/15 |
| Last modified on | 2023/05/15 11:52:47 |
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Basic information
Public title
Research on Effective Follow-up Procedures During the Medication Period - Utilization of Tracing Report Template -
Acronym
Research on Effective Follow-up Procedures During the Medication Period - Utilization of Tracing Report Template -
Scientific Title
Research on Effective Follow-up Procedures During the Medication Period - Utilization of Tracing Report Template -
Scientific Title:Acronym
Research on Effective Follow-up Procedures During the Medication Period - Utilization of Tracing Report Template -
Region
| Japan |
Condition
Condition
Diabetes, Constipation, Sleep disorders, Overactive bladder
Classification by specialty
| Medicine in general | Hepato-biliary-pancreatic medicine | Endocrinology and Metabolism |
| Psychosomatic Internal Medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The pharmacist should follow up with the patient during the home medication period and provide feedback to the attending physician using a tracing report as issues arise. The following changes under utilization of the tracing report preparation template, which guides their checking essential points, will be examined.
1.Number of tracing reports submitted
2. Content of the tracing report
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Changes in the number of tracing reports submitted by pharmacists to attending physicians on the subject drug
Key secondary outcomes
1. Changes in the number of tracing reports submitted for all drugs, including those not covered in this study
2. Changes in the content of text information in tracing reports
3. Change in the number of additional service fee of the NHI system
4. Change in the percentage of the number of tracing reports generated out of the number of follow-ups during the medication period
Base
Study type
Observational
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
Patients
1. Those who are at least 18 years of age and visited the participating institutions during the study period.
2. Those who were eligible to submit a tracing report.
3. Those who understood the opt-out document and did not refuse to cooperate.
Pharmacists
1. Those who received an explanation of the implementation procedures from the principal investigator at the research site and who attended to patients who were eligible to submit a tracing report.
2. Those who gave consent
Key exclusion criteria
N/A
Target sample size
480
Research contact person
Name of lead principal investigator
| 1st name | Yoshiko |
| Middle name | |
| Last name | Tominaga |
Organization
Niigata University of Pharmacy and Applied Life Sciences
Division name
School of Pharmacy, Laboratory of Social Pharmacy
Zip code
956-8603
Address
265-1 Higashijima, Akiha-ku, Niigata city, Niigata
TEL
0250-28-5306
y-tominaga@nupals.ac.jp
Public contact
Name of contact person
| 1st name | Yoshiko |
| Middle name | |
| Last name | Tominaga |
Organization
Niigata University of Pharmacy and Applied Life Sciences
Division name
School of Pharmacy, Laboratory of Social Pharmacy
Zip code
956-8603
Address
265-1 Higashijima, Akiha-ku, Niigata city, Niigata
TEL
0250-28-5306
Homepage URL
y-tominaga@nupals.ac.jp
Sponsor or person
Institute
Niigata University of Pharmacy and Applied Life Sciences
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
mSEED Co,. Ltd.
Sado Pharmacy
Shinano Pharmacy
Medic Taiyo Ltd.
KAKEHASHI Inc.
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Niigata University of Pharmacy and Applied Life Sciences Institutional Review Board
Address
265-1 Higashijima, Akiha-ku, Niigata city, Niigata
Tel
0250-25-1132
hirokawa@nupals.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
| 2023 | Year | 05 | Month | 15 | 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
| 2022 | Year | 11 | Month | 29 | Day |
Date of IRB
| 2023 | Year | 02 | Month | 27 | Day |
Anticipated trial start date
| 2023 | Year | 03 | Month | 01 | Day |
Last follow-up date
| 2023 | Year | 08 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
The pharmacist should follow up with the patient during the home medication period and provide feedback to the attending physician using a tracing report as issues arise. The following changes under utilization of the tracing report preparation template, which guides their checking essential points, will be examined.
1.Number of tracing reports submitted
2. Content of the tracing report
Management information
Registered date
| 2023 | Year | 05 | Month | 15 | Day |
Last modified on
| 2023 | Year | 05 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000058219
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
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| Registered date | File name |
