UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000053826 |
|---|---|
| Receipt number | R000061433 |
| Scientific Title | Research on the effectiveness of medication support device in patients who forget to take medication |
| Date of disclosure of the study information | 2024/03/11 |
| Last modified on | 2024/03/11 13:27:45 |
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Basic information
Public title
Research on the effectiveness of medication support device in patients who forget to take medication
Acronym
Research on the effectiveness of medication support device in patients
Scientific Title
Research on the effectiveness of medication support device in patients who forget to take medication
Scientific Title:Acronym
Research on the effectiveness of medication support device in patients
Region
| Japan |
Condition
Condition
lifestyle disease
Classification by specialty
| Geriatrics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Install a medication support device in the homes of lifestyle disease patients in Gunma Prefecture and have them use it for 3 months, and compare their adherence to the device when they are not using it to verify the effectiveness of the medication support device.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Number of remaining medications
Key secondary outcomes
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
The following are eligible to participate in the study: (1) the patient frequently forgets to take his/her medication and is unable to adequately manage his/her own medication, (2) the patient takes a single packaged medication, (3) the patient can take his/her medication independently or with minor assistance, (4) the patient has a general telephone line at home and can use a medication support device, (5) the patient has a healthy family and has given his/her consent for participation in the study.
Key exclusion criteria
Those who do not take single packaged medications, do not forget to take their medications, require full assistance in taking their medications, and those who do not have a general telephone line or cannot use medication support device.
Target sample size
6
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 Medical Informatics
Zip code
370-0033
Address
37-1, Nakaorui-Machi, Takasaki City, Gunma
TEL
0273521290
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 Medical Informatics
Zip code
370-0033
Address
37-1, Nakaorui-Machi, Takasaki City, Gunma
TEL
0273521290
Homepage URL
suzuki-r@takasaki-u.ac.jp
Sponsor or person
Institute
Takasaki University of Health and Welfare
Institute
Department
Personal name
Funding Source
Organization
Takasaki University of Health and Welfare
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Takasaki University of Health and Welfare
Address
37-1, Nakaorui-Machi, Takasaki City, Gunma
Tel
0273521290
suzuki-r@takasaki-u.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
| 2024 | Year | 03 | Month | 11 | 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
Preinitiation
Date of protocol fixation
| 2024 | Year | 03 | Month | 08 | Day |
Date of IRB
Anticipated trial start date
| 2024 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2028 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
No special note
Management information
Registered date
| 2024 | Year | 03 | Month | 11 | Day |
Last modified on
| 2024 | Year | 03 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000061433
| 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 |
