UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000035265 |
|---|---|
| Receipt number | R000040177 |
| Scientific Title | Efficacy of medication optimization protocol for older inpatients: a randomized controlled trial |
| Date of disclosure of the study information | 2018/12/21 |
| Last modified on | 2022/06/01 14:54:46 |
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Basic information
Public title
Efficacy of medication optimization protocol for older inpatients: a randomized controlled trial
Acronym
Efficacy of medication optimization protocol for older inpatients
Scientific Title
Efficacy of medication optimization protocol for older inpatients: a randomized controlled trial
Scientific Title:Acronym
Efficacy of medication optimization protocol for older inpatients
Region
| Japan |
Condition
Condition
Polypharmacy among older adults
Classification by specialty
| Medicine in general | Geriatrics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The objective of this trial is to evaluate the effect of multidisciplinary team-based deprescribing intervention on survival, re-hospitalization and unscheduled visits among older inpatients.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Composite of death, unscheduled visits, and re-hospitalization until 12 months after randomization.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Other |
Interventions/Control_1
A multidisciplinary team-based medication review and deprescribing proposal based on STOPP/START criteria and a medication optimization protocol.
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
| 65 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) Patients admitted to the internal medicine department of Kawasaki Municipal Tama Hospital (general internal medicine, gastroenterology, cardiology, respiratory medicine, endocrinology, nephrology, and neurology)
2) Patients aged 65 years or older at the time of enrollment
3) Patients who are confirmed to have 5 or more regular medications at the time of admission
4) Patients with expected hospitalization duration of 1 week or longer
5) Patients who are permitted to be given oral medication by the attending physician at the time of the trial participation
6) Patients with written agreement for study participation by themselves or by the substitute person with sufficient understanding
Key exclusion criteria
1) Patients whose attending physician do not agree to participate in the study
Target sample size
500
Research contact person
Name of lead principal investigator
| 1st name | Kenya |
| Middle name | |
| Last name | Ie |
Organization
St. Marianna university school of medicine/Kawasaki Municipal Tama Hospital
Division name
Department of internal medicine, division of general internal medicine
Zip code
214-8525
Address
1-30-37 Shukugawara, Tama-ku, Kawasaki city, Kanagawa, Japan
TEL
044-933-8111
iekenya0321@gmail.com
Public contact
Name of contact person
| 1st name | Satomi |
| Middle name | |
| Last name | Tsuchiya |
Organization
Kawasaki Municipal Tama Hospital
Division name
General Affairs Section
Zip code
214-8525
Address
1-30-37 Shukugawara, Tama-ku, Kawasaki city, Kanagawa, Japan
TEL
044-933-8111
Homepage URL
s-tsuchiya@marianna-u.ac.jp
Sponsor or person
Institute
St. Marianna university school of medicine
Institute
Department
Personal name
Funding Source
Organization
Ministry of education
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
St. Marianna University
Address
2-16-1 Sugao, Miyamae-ku, Kawasaki city, Kanagawa, Japan
Tel
044-977-8111
noriko.matsuda@marianna-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
| 2018 | Year | 12 | Month | 21 | 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
No longer recruiting
Date of protocol fixation
| 2018 | Year | 11 | Month | 23 | Day |
Date of IRB
| 2019 | Year | 03 | Month | 01 | Day |
Anticipated trial start date
| 2019 | Year | 03 | Month | 01 | Day |
Last follow-up date
| 2022 | Year | 12 | 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
| 2018 | Year | 12 | Month | 15 | Day |
Last modified on
| 2022 | Year | 06 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040177
| 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 |
