UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000033633 |
|---|---|
| Receipt number | 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 | 2023/05/10 19:00:50 |
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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
Cbm.kusph@gmail.com
Public contact
Name of contact person
| 1st name | Tomotsugu |
| Middle name | |
| Last name | Seki |
Organization
Graduate School of Medical Science, Kyoto Prefectural University of Medicine
Division name
Department of Cardiovascular Medicine
Zip code
602-8566
Address
465 Kajii-cho, Kawaramachi-Hirokoji, Kamigyo-ku, Kyoto, Japan
TEL
075-251-5511
Homepage URL
tseki@koto.kpu-m.ac.jp
Sponsor or person
Institute
Graduate School of Medicine and Public Health, Kyoto University
Institute
Department
Personal name
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
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
https://www.ncbi.nlm.nih.gov/pubmed/31829279
Publication of results
Published
Result
URL related to results and publications
doi:10.2196/40595
Number of participants that the trial has enrolled
111
Results
At the follow-up, the difference in the primary outcome (the achievement of therapeutically appropriate serum lithium levels between 0.4 and 1.0 mEq/L at 18 months after enrollment) was not statistically significant between the reminder group and the usual care group. The median number of serum lithium monitoring was significantly higher in the reminder group than in the usual care group. The exacerbation of mood disorders was similar between two groups.
Results date posted
| 2023 | Year | 05 | Month | 10 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2023 | Year | 03 | Month | 22 | Day |
Baseline Characteristics
A total of 48% of the patients had bipolar I disorder, 36% had bipolar II disorder, and 26% had recurrent major depression. The mean age of patients was 57 years, and 42.7% were men. The mean baseline lithium level was 0.61 mEq/L, and 73.6% of patients had lithium levels within the therapeutic range.
Participant flow
Trial enrollment started on November 1, 2018, and ended on March 31, 2020. We continued the follow-up until September 10, 2021. Of 167 patients who underwent screening, 56 were excluded (Figure 2) and 111 underwent randomization. Of them, 56 patients were randomly assigned to receive EHR-nested reminders (reminder group), and 55 received usual care (usual care group). One patient in the reminder group withdrew consent after randomization, and the remaining 110 patients were analyzed.
Adverse events
The mean serum eGFR and TSH levels were similar between the 2 groups (Table 2). One patient in the intervention group discontinued lithium carbonate owing to lithium intoxication,
and 1 patient in the usual care group temporarily discontinued but restarted it thereafter. One patient in the intervention group and 2 patients in the usual care group died for reasons unrelated to mood disorders, including suicide.
Outcome measures
The primary outcome was the achievement of therapeutically appropriate serum lithium levels between 0.4 and 1.0 mEq/L at 18 months after enrollment. At the follow-up, 38 (69.1%) patients in the reminder group and 33 (60.0%) patients in the usual care group achieved the primary outcome (odds ratio 2.14, 95% CI 0.82-5.58, P=.12). The median number of serum lithium monitoring was 2 in the reminder group and 0 in the usual care group (rate ratio 3.62; 95% CI 2.47-5.29, P<.001). The exacerbation of mood disorders occurred in 17 (31.5%) patients in the reminder group and in 16 (34.8%) patients in the usual care group (odds ratio 0.97, 95% CI 0.42-2.28, P=.95).
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Main results already published
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
| 2021 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
| 2021 | Year | 10 | Month | 31 | Day |
Date trial data considered complete
| 2021 | Year | 11 | Month | 30 | Day |
Date analysis concluded
| 2021 | Year | 12 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2018 | Year | 08 | Month | 06 | Day |
Last modified on
| 2023 | Year | 05 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037910
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