UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000047317 |
|---|---|
| Receipt number | R000053970 |
| Scientific Title | Observational study on behavior change through the use of personal health records (PHR) and health management apps |
| Date of disclosure of the study information | 2022/03/29 |
| Last modified on | 2022/11/14 08:49:51 |
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Basic information
Public title
Observational study on behavior change through the use of personal health records (PHR) and health management apps
Acronym
Kanazawa-PHR Study
Scientific Title
Observational study on behavior change through the use of personal health records (PHR) and health management apps
Scientific Title:Acronym
Kanazawa-PHR Study
Region
| Japan |
Condition
Condition
Metabolic syndrome
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Intervene in the lives of people who meet the diagnostic criteria for metabolic syndrome using a personal health record and a health management application that utilizes IoT devices to evaluate changes in behavior change stages and health examination results data from health checkups.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Change of Behavior Change Stage
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
3
Purpose of intervention
Prevention
Type of intervention
| Device,equipment | Behavior,custom |
Interventions/Control_1
Use of health checkup results app
Use of diet and health management apps
Interventions/Control_2
Use of health checkup results app
Interventions/Control_3
No use of apps
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
| 40 | years-old | <= |
Age-upper limit
| 75 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Those who are determined to have metabolic syndrome or to be in the pre-metabolic syndrome group in the health checkup
Key exclusion criteria
1. those who do not have metabolic syndrome or are not in the pre-metabolic syndrome group
2. those on insulin self-injection management for diabetes mellitus
3. subjects who are deemed inappropriate as research subjects by the principal investigator or a research associate.
Target sample size
90
Research contact person
Name of lead principal investigator
| 1st name | Takashi |
| Middle name | |
| Last name | Yoneda |
Organization
Kanazawa University Hospital
Division name
Internal medicine of Endocrinology and Metabolism
Zip code
920-8641
Address
Takara-machi 13-1, Kanazawa, Ishikawa
TEL
076-265-2778
endocrin@med.kanazawa-u.ac.jp
Public contact
Name of contact person
| 1st name | Mitsuhiro |
| Middle name | |
| Last name | Kometani |
Organization
Kanazawa University Hospital
Division name
Internal medicine of Endocrinology and Metabolism
Zip code
920-8641
Address
Takara-machi 13-1, Kanazawa, Ishikawa
TEL
076-265-2778
Homepage URL
mkome@med.kanazawa-u.ac.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
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethics Committee, Kanazawa University
Address
Takara-machi 13-1, Kanazawa, Ishikawa
Tel
076-265-2100
t-isomu@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
Other administrative information
Date of disclosure of the study information
| 2022 | Year | 03 | Month | 29 | 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
| 2021 | Year | 06 | Month | 29 | Day |
Date of IRB
| 2021 | Year | 06 | Month | 29 | Day |
Anticipated trial start date
| 2021 | Year | 06 | Month | 29 | Day |
Last follow-up date
| 2024 | Year | 04 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2022 | Year | 03 | Month | 29 | Day |
Last modified on
| 2022 | Year | 11 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053970
