UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000037769 |
|---|---|
| Receipt number | R000043053 |
| Scientific Title | Research on patients with medication support equipment |
| Date of disclosure of the study information | 2019/08/22 |
| Last modified on | 2020/08/13 09:14:19 |
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Basic information
Public title
Research on patients with medication support equipment
Acronym
Research on patients with medication support equipment
Scientific Title
Research on patients with medication support equipment
Scientific Title:Acronym
Research on patients with medication support equipment
Region
| Japan |
Condition
Condition
Not specified
Classification by specialty
| Not applicable |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Introduce medication support equipment to patient homes that require home visits, and confirm whether there are results such as improvement in medication adherence and reduction of burden on medication assistants.
Basic objectives2
Others
Basic objectives -Others
Improving medication adherence
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Evaluate the average number of remaining medicines for 2 months before and after the introduction of medication support devices.
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
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Device,equipment |
Interventions/Control_1
Introduction of medication support equipment for 2 months
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Adults, mainly elderly
Key exclusion criteria
Minors
Target sample size
14
Research contact person
Name of lead principal investigator
| 1st name | Takahashi |
| Middle name | |
| Last name | Yoshinori |
Organization
Gunma Pharmaceutical Association
Division name
Officer
Zip code
371-0013
Address
5-18-36 Nishi-Katagai-machi, Maebashi City, Gunma Prefecture
TEL
027-243-6650
gpa-dic@gunyaku.or.jp
Public contact
Name of contact person
| 1st name | Miyata |
| Middle name | |
| Last name | Hikaru |
Organization
Gunma Pharmaceutical Association
Division name
General Affairs Department Information Section
Zip code
371-0013
Address
5-18-36 Nishi-Katagai-machi, Maebashi City, Gunma Prefecture
TEL
027-243-6650
Homepage URL
gpa-dic@gunyaku.or.jp
Sponsor or person
Institute
Gunma Pharmaceutical Association
Institute
Department
Personal name
Funding Source
Organization
Gunma Prefectural Government Office
Organization
Division
Category of Funding Organization
Local Government
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Gunma Pharmaceutical Association
Address
5-18-36 Nishi-Katagai-machi, Maebashi City, Gunma Prefecture
Tel
027-243-6650
rinri@gunyaku.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
| 2019 | Year | 08 | Month | 22 | 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
4
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
Completed
Date of protocol fixation
| 2019 | Year | 08 | Month | 22 | Day |
Date of IRB
| 2019 | Year | 08 | Month | 15 | Day |
Anticipated trial start date
| 2019 | Year | 08 | Month | 22 | Day |
Last follow-up date
| 2020 | Year | 03 | Month | 23 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2019 | Year | 08 | Month | 22 | Day |
Last modified on
| 2020 | Year | 08 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043053
| 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 |
