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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000035265
Receipt No. 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 2019/06/19

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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
Email 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
Email s-tsuchiya@marianna-u.ac.jp

Sponsor
Institute St. Marianna university school of medicine
Institute
Department

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
Email 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 Preinitiation
Date of protocol fixation
2018 Year 11 Month 23 Day
Date of IRB
Anticipated trial start date
2019 Year 03 Month 01 Day
Last follow-up date
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
2019 Year 06 Month 19 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040177

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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