UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000061033 |
|---|---|
| Receipt number | R000068336 |
| Scientific Title | Verification of the Effectiveness of Nursing Interventions Using the "System for Nurses to Support Medication Adherence in Older Adults" Through a Non-Randomized Controlled Trial |
| Date of disclosure of the study information | 2026/03/24 |
| Last modified on | 2026/03/24 10:27:58 |
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Basic information
Public title
Verification of the Effectiveness of Nursing Interventions Using the "System for Nurses to Support Medication Adherence in Older Adults" Through a Non-Randomized Controlled Trial
Acronym
Nursing Intervention Study on Medication Adherence in Older Adults
Scientific Title
Verification of the Effectiveness of Nursing Interventions Using the "System for Nurses to Support Medication Adherence in Older Adults" Through a Non-Randomized Controlled Trial
Scientific Title:Acronym
Nursing Intervention Study on Medication Adherence in Older Adults
Region
| Japan |
Condition
Condition
Older adults with various chronic diseases (not limited to a specific disease)
Classification by specialty
| Nursing |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study aims to evaluate the effectiveness of a nursing intervention using the "Nursing Support System for Medication Adherence in Older Adults" for elderly patients admitted to community-based integrated care wards, from the perspective of improving medication adherence.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Change in medication adherence score measured by the 12-item Medication Adherence Assessment Tool for Older Adults
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Behavior,custom |
Interventions/Control_1
In the intervention group, nurses use the "Nursing Support System for Medication Adherence in Older Adults" to perform an initial assessment within 3 days of admission. Based on the system's radar chart, nurses identify strengths and weaknesses in patients' medication self-management, provide individualized counseling, explain medication management strategies, offer motivational support, and, if necessary, provide guidance to family members. Reassessments and adjustments to the nursing plan are conducted regularly throughout the intervention period (2-8 weeks during hospitalization).
Interventions/Control_2
In the control group, the "Nursing Support System for Medication Adherence in Older Adults" will not be used, and usual nursing support for medication adherence will be provided.
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
| 75 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1. Patients admitted to community-based integrated care wards at a Hospital
2. Aged 65-74 years and under the care of the participating nurse
3. Expected hospital stay >=2 weeks
4. Continuously taking cardiovascular medications
5. Self-managing >=3 medications with family support
6. Able to provide written informed consent
7. Approved for participation by the attending physician
Key exclusion criteria
1. Severe hearing or language impairments preventing understanding of the study or providing consent
2. Severe physical illness or acute exacerbation making the intervention difficult, or life expectancy judged to be extremely short
3. Diagnosis of dementia or MCI, or cognitive impairment leading to family- or healthcare provider-led medication management
4. History of psychiatric disorders or current pharmacotherapy for psychiatric conditions
5. Hospital stay <2 weeks, making intervention or evaluation insufficient
6. Complete discontinuation of all oral medications during the intervention period or after discharge
Target sample size
34
Research contact person
Name of lead principal investigator
| 1st name | Kanako |
| Middle name | |
| Last name | Sakane |
Organization
Tottori University
Division name
School of Health Science, Faculty of Medicine
Zip code
683-8503
Address
86 Nishi-cho, Yonago-shi, Tottori 683-8503, Japan
TEL
0859-38-6304
k-sakane@tottori-u.ac.jp
Public contact
Name of contact person
| 1st name | Saki |
| Middle name | |
| Last name | Moriwaki |
Organization
Shimane University
Division name
Department of Fundamental Nursing, School of Medicine
Zip code
6938501
Address
89-1 Enya-cho, Izumo-shi, Shimane 693-8501, Japan
TEL
0853-20-2338
Homepage URL
moriwak@med.shimane-u.ac.jp
Sponsor or person
Institute
SHIMANE University
Institute
Department
Personal name
Funding Source
Organization
Japan Science and Technology Agency (JST)
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
Institutional Review Board for Nursing Research, Shimane University School of Medicine
Address
89-1 Enya-cho, Izumo-shi, Shimane 693-8501, Japan
Tel
0853-23-2111
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
| 2026 | Year | 03 | Month | 24 | 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
Enrolling by invitation
Date of protocol fixation
| 2025 | Year | 11 | Month | 13 | Day |
Date of IRB
| 2025 | Year | 10 | Month | 20 | Day |
Anticipated trial start date
| 2026 | Year | 01 | Month | 23 | Day |
Last follow-up date
| 2026 | Year | 04 | 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
| 2026 | Year | 03 | Month | 24 | Day |
Last modified on
| 2026 | Year | 03 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000068336
