UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000049315 |
|---|---|
| Receipt number | R000056165 |
| Scientific Title | Effect of encouraging people with non-communicable diseases to receive medical consultation based on medical data |
| Date of disclosure of the study information | 2022/11/01 |
| Last modified on | 2024/04/26 09:44:37 |
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Basic information
Public title
Effect of encouraging people with non-communicable diseases to receive medical consultation based on medical data
Acronym
Effect of encouraging people with non-communicable diseases to receive medical consultation
Scientific Title
Effect of encouraging people with non-communicable diseases to receive medical consultation based on medical data
Scientific Title:Acronym
Effect of encouraging people with non-communicable diseases to receive medical consultation
Region
| Japan |
Condition
Condition
hypertension, dyslipidemia, diabetes mellitus
Classification by specialty
| Medicine in general | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine the effect of customized information on the behavior and disease management status of individuals with non-communicable diseases who need medical consultations
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Proportion of patients who receive treatment and retained treatment
Key secondary outcomes
Disease management status for non-communicable diseases
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
NO
Dynamic allocation
NO
Institution consideration
Blocking
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Behavior,custom |
Interventions/Control_1
Intervention group
Clustering of factors related to medical consultation behavior based on medical data, and sending of medical consultation notifications appropriate to the appeal points according to the characteristics of the clusters
Interventions/Control_2
Sending regular medical consultation notifications
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Insured persons in the Health Insurance Association
1. Persons who meet any of the following criteria based on the results of the medical checkup
- Blood pressure: Systolic blood pressure 160 mmHg or higher and/or diastolic blood pressure 100 mmHg or higher
- Lipid: Low-Density Lipoprotein (LDL) cholesterol level 180 mg/dL or higher and/or High-Density Lipoprotein (HDL) cholesterol level 30 mg/dL or lower and/or triglycerides 500 mg/dL or higher
- Blood glucose: Fasting blood glucose 140 mg/dL or higher and/or Hemoglobin A1c (HbA1c) 7.0% or higher
2. Those who have no medical history of the target disease
Key exclusion criteria
Those who refused to participate in the study
Target sample size
300
Research contact person
Name of lead principal investigator
| 1st name | Masashi |
| Middle name | |
| Last name | Kanai |
Organization
Kanazawa University
Division name
Institute of Transdisciplinary Sciences for Innovation
Zip code
920-1192
Address
Kakuma-machi, Kanazawa, Ishikawa
TEL
076-234-6333
kanaimasa07@staff.kanazawa-u.ac.jp
Public contact
Name of contact person
| 1st name | Kento |
| Middle name | |
| Last name | Takeyama |
Organization
PREVENT inc.
Division name
Department of Business Planning
Zip code
461-0004
Address
1-26-12, Aoi, Higashi-ku, Nagoya, Aichi
TEL
052-715-7955
Homepage URL
business_planning@prevent.co.jp
Sponsor or person
Institute
Kanazawa University
Institute
Department
Personal name
Funding Source
Organization
Ministry of Health, Labour and Welfare
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
PREVENT inc., Health Insurance Association for Suzuyo
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kanazawa University
Address
Kakuma-machi, Kanazawa, Ishikawa
Tel
076-264-5920
yugosomu@adm.kanazawa-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
鈴与健康保険組合
Other administrative information
Date of disclosure of the study information
| 2022 | Year | 11 | 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
No longer recruiting
Date of protocol fixation
| 2022 | Year | 09 | Month | 15 | Day |
Date of IRB
| 2022 | Year | 09 | Month | 15 | Day |
Anticipated trial start date
| 2022 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2024 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
| 2024 | Year | 07 | Month | 31 | Day |
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2022 | Year | 10 | Month | 25 | Day |
Last modified on
| 2024 | Year | 04 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000056165
| 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 |
