UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000050712 |
|---|---|
| Receipt number | R000057776 |
| Scientific Title | Case Study on the Evaluation of the Effectiveness of the "Medication Adherence Nursing Support System for Older Adults " |
| Date of disclosure of the study information | 2023/05/01 |
| Last modified on | 2024/03/29 09:23:51 |
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Basic information
Public title
A Study on the Evaluation of the Effectiveness of a Nursing System to Support the Self-Management of Medications for Older Adults
Acronym
Research on "Nursing System to Support Self-Management of Medication for Older Adults
Scientific Title
Case Study on the Evaluation of the Effectiveness of the "Medication Adherence Nursing Support System for Older Adults "
Scientific Title:Acronym
Case Study Using the "Medication Adherence Nursing Support System for Older Adults
Region
| Japan |
Condition
Condition
cardiovascular disease
Classification by specialty
| Medicine in general | Nursing |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to examine the effectiveness of cases in which nurses provide assessment and support to older adults using the Medication Adherence Nursing Support System for Older Adults.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Medication Adherence
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
| Behavior,custom |
Interventions/Control_1
Assessment and Support of Medication Adherence in Older Adults Using the "Medication Adherence Nursing Support System for Older Adults" by nurses.
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
| 65 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
(1) Patients who have been continuously self-management their medications for at least 6 months prior to admission and are considered to need to continue taking their medications after discharge from the hospital.
(2) Those who are able to have a conversation regarding the explanation of the study and sign the consent form.
(3) Those who have obtained permission from their physicians to participate in the study.
(4) Those who are scheduled to be hospitalized for at least one week after the research request.
Key exclusion criteria
Those who have been diagnosed with dementia and those who need care in all aspects of their lives due to cognitive decline.
Target sample size
2
Research contact person
Name of lead principal investigator
| 1st name | Kanako |
| Middle name | |
| Last name | Sakane |
Organization
Shimane University
Division name
Department of Fundamental Nursing, School of Medicine
Zip code
6938501
Address
89-1 Enya-cho, Izumoshi, Shimane
TEL
083202321
k-sakane@med.shimane-u.ac.jp
Public contact
Name of contact person
| 1st name | Kanako |
| Middle name | |
| Last name | Sakane |
Organization
Shimane University
Division name
Department of Fundamental Nursing, School of Medicine
Zip code
693-8501
Address
89-1 Enya-cho, Izumoshi, Shimane
TEL
0953202321
Homepage URL
k-sakane@med.shimane-u.ac.jp
Sponsor or person
Institute
Shimane University
Institute
Department
Personal name
Funding Source
Organization
Ministry of Education, Culture, Sports, Science and Technology
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Shimane University Nursing Research Ethics Committee
Address
89-1 Enya-cho, Izumoshi, Shimane
Tel
0853202025
mga-kikaku@office.shimane-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
| 2023 | Year | 05 | Month | 01 | 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
Terminated
Date of protocol fixation
| 2023 | Year | 04 | Month | 20 | Day |
Date of IRB
| 2023 | Year | 09 | Month | 04 | Day |
Anticipated trial start date
| 2023 | Year | 05 | Month | 01 | Day |
Last follow-up date
| 2023 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2023 | Year | 03 | Month | 29 | Day |
Last modified on
| 2024 | Year | 03 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000057776
