UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000032388 |
|---|---|
| Receipt number | R000036905 |
| Scientific Title | A study of the effect of implementing a medication support system in a group home |
| Date of disclosure of the study information | 2018/04/26 |
| Last modified on | 2020/10/27 09:05:10 |
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Basic information
Public title
A study of the effect of implementing a medication support system in a group home
Acronym
A study of the effect of implementing a medication support system
Scientific Title
A study of the effect of implementing a medication support system in a group home
Scientific Title:Acronym
A study of the effect of implementing a medication support system
Region
| Japan |
Condition
Condition
Not applicable
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To analyze whether there is any change in workers' feelings of burden of medication management for elderly people after the implementation of a medication support system in a group home.
Basic objectives2
Others
Basic objectives -Others
To compare workers' feelings of burden in an intervention facility and those in a control facility.
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
After the implementation of the system, it is expected that workers feelings of burden will be improved, drug-preparation time can be reduced, and the number of incidents will be reduced.
Key secondary outcomes
It is expected that workers burden of medication management in the intervention facility will be lighter than that of the control facility.
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
We conduct a monitoring test of the medication support system in a group home for three 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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Workers in charge of medication management both in the intervention and control facilities.
Key exclusion criteria
Workers not in charge of medication management both in the intervention and control facilities.
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Ryoji |
| Middle name | |
| Last name | Suzuki |
Organization
Takasaki University of Health and Welfare
Division name
Department of Healthcare Informatics
Zip code
370-0033
Address
37-1 Nakaorui-Machi, Takasaki, Gunma
TEL
027-352-1290
suzuki-r@takasaki-u.ac.jp
Public contact
Name of contact person
| 1st name | Ryoji |
| Middle name | |
| Last name | Suzuki |
Organization
Takasaki University of Health and Welfare
Division name
Department of Healthcare Informatics
Zip code
370-0033
Address
37-1 Nakaorui-Machi, Takasaki, Gunma
TEL
027-352-1290
Homepage URL
suzuki-r@takasaki-u.ac.jp
Sponsor or person
Institute
Department of Healthcare Informatics, Takasaki University of Health and Welfare
Institute
Department
Personal name
Funding Source
Organization
Japan Science and Technology Agency
Organization
Division
Category of Funding Organization
Government offices of other countries
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Tohoku University
Address
2-1 Seiryo-Cho, Aobaku, Sendai, Miyagi
Tel
022-717-8007
med-kenkyo@grp.tohoku.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
グループホーム（岩手県）
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 04 | Month | 26 | Day |
Related information
URL releasing protocol
Japanese Journal of Telemedicine and Telecare
Publication of results
Partially published
Result
URL related to results and publications
Japanese Journal of Telemedicine and Telecare
Number of participants that the trial has enrolled
8
Results
The drug distribution support device (DDSD) was developed as a locker-type system that operates on AC 100 V. Care workers completed a questionnaire before and after using the DDSD for 3 months. They reported that the average time spent on medication set and medication distribution was reduced. Additionally, the incidence of forgetting to distribute medicine, mistaken person, and mistaken medication had reduced slightly.
Results date posted
| 2020 | Year | 04 | Month | 27 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2019 | Year | 06 | Month | 20 | Day |
Baseline Characteristics
Care workers completed a questionnaire before and after using the DDSD for 3 months.
Participant flow
Care workers completed a questionnaire before and after using the DDSD for 3 months.
Adverse events
nothing
Outcome measures
The incidence of forgetting to distribute medicine, mistaken person, and mistaken medication.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Main results already published
Date of protocol fixation
| 2018 | Year | 04 | Month | 23 | Day |
Date of IRB
| 2018 | Year | 08 | Month | 21 | Day |
Anticipated trial start date
| 2018 | Year | 04 | Month | 23 | Day |
Last follow-up date
| 2018 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
| 2018 | Year | 09 | Month | 30 | Day |
Date trial data considered complete
| 2018 | Year | 09 | Month | 30 | Day |
Date analysis concluded
| 2023 | Year | 07 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2018 | Year | 04 | Month | 26 | Day |
Last modified on
| 2020 | Year | 10 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036905
