UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000059861 |
|---|---|
| Receipt number | R000068455 |
| Scientific Title | Standardization and Efficacy Verification of Intervention Methods for Outpatient Dementia Patients and their Family Caregivers in Community Pharmacy: A Randomized Parallel-Group Comparative Trial |
| Date of disclosure of the study information | 2026/08/01 |
| Last modified on | 2025/11/23 16:43:23 |
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Basic information
Public title
Study for Better Support by Pharmacists for Patients with Dementia and their Families
Acronym
Pharmacy Alignment for Care Efficacy Study (PACE Study)
Scientific Title
Standardization and Efficacy Verification of Intervention Methods for Outpatient Dementia Patients and their Family Caregivers in Community Pharmacy: A Randomized Parallel-Group Comparative Trial
Scientific Title:Acronym
Pharmacy Alignment for Care Efficacy Study (PACE Study)
Region
| Japan |
Condition
Condition
Dementia
Classification by specialty
| Geriatrics | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify the effects of active information gathering from other healthcare professionals by community pharmacists, and the subsequent identification and management of Drug-Related Problems (DRPs) in patients with dementia and their caregivers, on the caregiver burden of family caregivers
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Change in Caregiver Burden
Change in J-ZBI_8 score before and after the intervention
Key secondary outcomes
Drug-Related Problems (DRPs) and Their Management
(Number or type of newly identified and resolved Drug-Related Problems)
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Cluster
Blinding
Open -no one is blinded
Control
Active
Stratification
YES
Dynamic allocation
NO
Institution consideration
Institution is considered as a block.
Blocking
YES
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Behavior,custom |
Interventions/Control_1
Actively collect information from the attending physician and care manager using a original information request form
Interventions/Control_2
Usual care
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. Patients receiving anti-dementia medication at the participating pharmacies and their carers
2. Written consent for study participation has been obtained from the research subject themselves or their authorized representative
Key exclusion criteria
1.Dementia patients receiving home care service by a pharmacist
2.Dementia patients visiting the pharmacy alone, without family or carers
3.Other subjects deemed unsuitable for safe study conduct by the principal investigator (e.g., where the relationship is deemed unfavorable, such as the patient experiencing harassment from a carer or where there is a potential for violent behavior)
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Mitsuko |
| Middle name | |
| Last name | Onda |
Organization
Osaka Medical and Pharmaceutical University
Division name
Faculty of Pharmacy
Zip code
569-1094
Address
4-20-1, Nasahara, Takatsuki, Osaka, Japan
TEL
+81-72-690-1059
mitsuko.onda@ompu.ac.jp
Public contact
Name of contact person
| 1st name | Yoko |
| Middle name | |
| Last name | Nanaumi |
Organization
Advance Pharma Research Office
Division name
Pharmacy management
Zip code
631-0805
Address
3-6-2, Ukyo, Nara, Japan
TEL
0742-71-9501
Homepage URL
advancepharmaresearch@gmail.com
Sponsor or person
Institute
Osaka Medical and Pharmaceutical University
Institute
Department
Personal name
Funding Source
Organization
Osaka Medical and Pharmaceutical University
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
Osaka Medical and Pharmaceutical University, Research Ethics Committee
Address
2-7 Daigaku-machi, Takatsuki, Osaka 569-8686, Japan
Tel
+81-72-683-1221
rinri@ompu.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 | 08 | 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
Preinitiation
Date of protocol fixation
| 2025 | Year | 12 | Month | 31 | Day |
Date of IRB
Anticipated trial start date
| 2026 | Year | 05 | Month | 01 | Day |
Last follow-up date
| 2027 | Year | 06 | 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
| 2025 | Year | 11 | Month | 23 | Day |
Last modified on
| 2025 | Year | 11 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000068455
