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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000033633
Receipt No. R000037910
Scientific Title Pragmatic Randomized Controlled Trial of Electronic Health Record-based Reminder System to Measure Serum Lithium Levels among Patients with Mood Disorder
Date of disclosure of the study information 2018/10/01
Last modified on 2019/08/07

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Basic information
Public title Pragmatic Randomized Controlled Trial of Electronic Health Record-based Reminder System to Measure Serum Lithium Levels among Patients with Mood Disorder
Acronym Kyoto tOyooka Nested cOntrolled Trial Of RemInders (KONOTORI) Study
Scientific Title Pragmatic Randomized Controlled Trial of Electronic Health Record-based Reminder System to Measure Serum Lithium Levels among Patients with Mood Disorder
Scientific Title:Acronym Kyoto tOyooka Nested cOntrolled Trial Of RemInders (KONOTORI) Study
Region
Japan

Condition
Condition Bipolar disorder and major depressive disorder
Classification by specialty
Psychiatry
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To evaluate the efficacy of electric health record-based reminder system to measure serum lithium levels
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes The proportion of patients with serum lithium level between 0.4 and 1.0 mEq/l between 18 and 24 months after inclusion
Key secondary outcomes 1) Number of tests of serum lithium level within 18-24 months after inclusion
2) Exacerbation of mood disorder including admission, a dose increase of lithium, an addition of antipsychotics, antidepressants or mood stabilizers
3) The proportion of days when lithium was prescribed during the study period

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Active
Stratification YES
Dynamic allocation NO
Institution consideration Institution is not considered as adjustment factor.
Blocking YES
Concealment No need to know

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine Other
Interventions/Control_1 Reminders of blood test of serum lithium levels per every 6 months
Interventions/Control_2 Standard 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
18 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria 1) Bipolar disorder or major depressive disorder according to DSM-5
2) Taking lithium carbonate longer than six months
3) Need to continue lithium carbonate over 18 months (as judged by treating psychiatrist)
Key exclusion criteria 1) Prescribed lithium for a condition other than mood disorder
2) Who did not provide written informed consent
3) Schizophrenia
4) Inappropriate/unable to participate in the trial (as judged by treating psychiatrist)
5) Serious suicide intent (as judged by treating psychiatrist)
6) Lithium intoxication
7) Pregnancy
8) Researcher of the trial and their family
9) Who cannot read Japanese
10) Contraindication of lithium
11) Participation in another clinical trial
12) Inpatients
13) End-stage physical disease
14) Who did not have serum lithium level measurement at baseline
15) Who did not visit hospital between 4-8 months after inclusion
Target sample size 120

Research contact person
Name of lead principal investigator
1st name Toshi A.
Middle name
Last name Furukawa
Organization Graduate School of Medicine and Public Health, Kyoto University
Division name Department of Health Promotion and Human Behavior
Zip code 606-8501
Address Yoshida Konoe-cho, Sakyo-ku, Kyoto, Japan
TEL 075-753-9491
Email Cbm.kusph@gmail.com

Public contact
Name of contact person
1st name Tomotsugu
Middle name
Last name Seki
Organization Graduate School of Medicine and Public Health, Kyoto University
Division name Department of Pharmacoepidemiology
Zip code 606-8501
Address Yoshida Konoe-cho, Sakyo-ku, Kyoto, Japan
TEL 075-753-9469
Homepage URL
Email info@pe.sph.med.kyoto-u.ac.jp

Sponsor
Institute Graduate School of Medicine and Public Health, Kyoto University
Institute
Department

Funding Source
Organization Japan Society for the Promotion of Science
Organization
Division
Category of Funding Organization Japanese Governmental office
Nationality of Funding Organization

Other related organizations
Co-sponsor Toyooka Hospital
Name of secondary funder(s)

IRB Contact (For public release)
Organization Kyoto University Graduate School and Faculty of Medicine, Kyoto University Hospital, Ethics Comittee
Address Yoshida Konoe-cho, Sakyo-ku, Kyoto, Japan
Tel 075-753-4642
Email ethcom@kuhp.kyoto-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 公立豊岡病院 (兵庫県)

Other administrative information
Date of disclosure of the study information
2018 Year 10 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 Open public recruiting
Date of protocol fixation
2018 Year 07 Month 20 Day
Date of IRB
2018 Year 09 Month 26 Day
Anticipated trial start date
2018 Year 11 Month 01 Day
Last follow-up date
2022 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
2018 Year 08 Month 06 Day
Last modified on
2019 Year 08 Month 07 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037910

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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