UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000058847 |
|---|---|
| Receipt number | R000067292 |
| Scientific Title | Development and Implementation Study of a Collaborative Intervention Model Among Medicine, Dentistry, and Pharmacies Through Home-Visit Medical Care |
| Date of disclosure of the study information | 2025/12/01 |
| Last modified on | 2025/08/20 11:32:41 |
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Basic information
Public title
Development and Implementation Study of a Collaborative Intervention Model Among Medicine, Dentistry, and Pharmacies Through Home-Visit Medical Care
Acronym
Medical Dental Pharmacy Collaboration in Home Care
Scientific Title
Development and Implementation Study of a Collaborative Intervention Model Among Medicine, Dentistry, and Pharmacies Through Home-Visit Medical Care
Scientific Title:Acronym
Medical Dental Pharmacy Collaboration in Home Care
Region
| Japan |
Condition
Condition
Older adult requiring nursing care
Classification by specialty
| Dental medicine | Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Background
Collaboration among medical and nursing care professionals supports community based care for older adults. While medicine dental cooperation is common, collaboration with pharmacies is rare. For home care patients, especially with dysphagia, pharmacy input on medication use and drug adjustments is important. Adding dentistry to medicine pharmacy cooperation may create a more comprehensive system.
Objectives
This study aims to build a medicine pharmacy dentistry collaboration model. A demonstration will test pharmacy to dental referral using Sugi or Sakura pharmacies and nearby home visit dental clinics. The study will evaluate effects on patient conditions and improve healthcare for older adults.
Basic objectives2
Others
Basic objectives -Others
Evaluation of the Effects of a Collaborative Model Among Medicine, Pharmacies, and Dentistry on the General and Nutritional Status of Older Adults Requiring Long-Term Care
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Primary Endpoint
General condition, blood test data, and oral status before and after referral to a home-visit dental clinic
Secondary Endpoints
Adverse events (hospitalization, death, pneumonia)
Medication changes due to interprofessional collaboration
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
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Behavior,custom | Maneuver |
Interventions/Control_1
Home visit dental care for older adults requiring long-term care without prior dental or oral management
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
Among home care patients receiving home visit dispensing from Sugi Pharmacy or Sakura Pharmacy, or home visit dental care from participating dental clinics, those without existing pharmacy dental collaboration such as exchange of information forms and who provide consent to participate in the study will be included. Adult patients of either sex are eligible.
Key exclusion criteria
If a participant meets any of the following conditions, participation in the study will be discontinued:
Withdrawal of consent by the participant
Any other situation in which the study investigators judge that discontinuation is appropriate
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Kanako |
| Middle name | |
| Last name | Yoshimi |
Organization
Institute of Science Tokyo
Division name
Department of Dysphasia rehabilitation, Division of Medical and Dental Sciences, Graduate school of ISCT
Zip code
1138549
Address
1-5-45, Yushima, Bunkyo-ku, Tokyo
TEL
03-5803-5560
k.yoshimi.gerd@tmd.ac.jp
Public contact
Name of contact person
| 1st name | Kanako |
| Middle name | |
| Last name | Yoshimi |
Organization
Institute of Science Tokyo
Division name
Department of Dysphasia rehabilitation, Division of Medical and Dental Sciences
Zip code
1138549
Address
1-5-45, Yushima, Bunkyo-ku, Tokyo
TEL
03-5803-5562
Homepage URL
k.yoshimi.gerd@tmd.ac.jp
Sponsor or person
Institute
Institute of Science Tokyo
Institute
Department
Personal name
Funding Source
Organization
Institute of Science Tokyo
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethics Committee of Institute of Science Tokyo
Address
1-5-45, Yushima, Bunkyo-ku, Tokyo
Tel
03-5803-4547
info.bec@tmd.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
| 2025 | Year | 12 | 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 | 08 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2025 | Year | 12 | Month | 01 | Day |
Last follow-up date
| 2029 | Year | 03 | Month | 31 | 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 | 08 | Month | 20 | Day |
Last modified on
| 2025 | Year | 08 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067292
