UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000042922 |
|---|---|
| Receipt number | R000048979 |
| Scientific Title | Influence investigation by the pharmacist follow after the medication |
| Date of disclosure of the study information | 2021/01/06 |
| Last modified on | 2022/07/21 18:13:42 |
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Basic information
Public title
Influence investigation by the pharmacist follow after the medication
Acronym
Influence investigation by the pharmacist follow after the medication
Scientific Title
Influence investigation by the pharmacist follow after the medication
Scientific Title:Acronym
Influence investigation by the pharmacist follow after the medication
Region
| Japan |
Condition
Condition
Diabetes
Classification by specialty
| Medicine in general | Not applicable |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Whether the follow of the pharmacist after the medication is effective and examines the effectiveness of the method
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
medication adherence
Key secondary outcomes
The number of side effects
Change of the HbA1c level
Patient evaluation of the pharmacist follow
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
3
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
Follow with the telephone of the pharmacist
Interventions/Control_2
Follow with the letter of the pharmacist
Interventions/Control_3
No follow of the pharmacist
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
The patient whom antidiabetic agent was prescribed for more than 28 days
Key exclusion criteria
The patient who receives visit drug management instruction
The patient who cannot list the VAS method by a physical reason
The patient who does not have legal representative
Target sample size
385
Research contact person
Name of lead principal investigator
| 1st name | Shutaro |
| Middle name | |
| Last name | Yokota |
Organization
Chiba Pharmaceutical Association
Division name
Drug Information Center
Zip code
260-0025
Address
9-2 Tonyacho, Chuo-ku, Chiba-shi, Chiba, 260-0025 Japan
TEL
043-247-1352
drug-info@c-yaku.or.jp
Public contact
Name of contact person
| 1st name | Shutaro |
| Middle name | |
| Last name | Yokota |
Organization
Chiba Pharmaceutical Association
Division name
Drug Information Center
Zip code
260-0025
Address
9-2 Tonyacho, Chuo-ku, Chiba-shi, Chiba, 260-0025 Japan
TEL
043-247-1352
Homepage URL
drug-info@c-yaku.or.jp
Sponsor or person
Institute
others
Chiba Pharmaceutical Association
Institute
Department
Personal name
Funding Source
Organization
others
Chiba Pharmaceutical Association
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
Chiba Pharmaceutical Association
Address
9-2 Tonyacho, Chuo-ku, Chiba-shi, Chiba, 260-0025 Japan
Tel
043-247-1352
drug-info@c-yaku.or.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 | 06 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
Result
URL related to results and publications
Number of participants that the trial has enrolled
37
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
No longer recruiting
Date of protocol fixation
| 2020 | Year | 10 | Month | 27 | Day |
Date of IRB
| 2020 | Year | 10 | Month | 27 | Day |
Anticipated trial start date
| 2021 | Year | 01 | Month | 25 | Day |
Last follow-up date
| 2021 | Year | 10 | Month | 31 | Day |
Date of closure to data entry
| 2022 | Year | 10 | Month | 31 | Day |
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2021 | Year | 01 | Month | 06 | Day |
Last modified on
| 2022 | Year | 07 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048979
