UMIN-CTR Clinical Trial

Recruitment status Main results already published
Unique ID issued by UMIN UMIN000032388
Receipt No. 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 (Ver. 6)

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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
Email 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
Email suzuki-r@takasaki-u.ac.jp

Sponsor
Institute Department of Healthcare Informatics, Takasaki University of Health and Welfare
Institute
Department

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
Email 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000036905