UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000047642 |
|---|---|
| Receipt number | R000054328 |
| Scientific Title | Effect of Personal Health Record (PHR) and Health Management App Utilization in Online Medical Practice |
| Date of disclosure of the study information | 2022/05/09 |
| Last modified on | 2023/05/23 16:34:14 |
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Basic information
Public title
Effect of Personal Health Record (PHR) and Health Management App Utilization in Online Medical Practice
Acronym
Online-Kanazawa-PHR Study
Scientific Title
Effect of Personal Health Record (PHR) and Health Management App Utilization in Online Medical Practice
Scientific Title:Acronym
Online-Kanazawa-PHR Study
Region
| Japan |
Condition
Condition
Lifestyle-related diseases (type 2 diabetes, obesity, dyslipidemia (except familial), hypertension, hyperuricemia, etc.)
Classification by specialty
| Medicine in general | Cardiology | Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To intervene in the lives of patients with lifestyle-related diseases receiving online medical care using personal health records and health management apps utilizing IoT devices to assess changes in behavior change stages and blood check results
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
i) Frequency of application use
ii) Frequency of viewing health checkup data
iii) Recorded information on the app (all information obtained from the attached app, including number of records, calorie intake, nutrient composition, number of meals, number of steps, calories consumed, etc.) *Only for relevant app users
(iv) Changes in clinical laboratory tests related to lifestyle-related diseases (abdominal circumference, triglycerides, HDL cholesterol, systolic blood pressure, diastolic blood pressure, fasting blood glucose, etc.)
(v) Changes in number of medications and medication compliance
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Device,equipment |
Interventions/Control_1
Use of health checkup results app
Use of diet and health management apps
Interventions/Control_2
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
(1) Patients with lifestyle-related diseases aged 20 years or older (regardless of gender)
2) HbA1c between 5.2 and 7.5% (at the time of study enrollment)
(3) Patients who give written consent to participate in this study
(4) Patients who can operate a smartphone
(5) Patients who are receiving online medical care
Key exclusion criteria
(i) Patients with diabetes mellitus requiring insulin therapy
(ii) Other patients who are deemed inappropriate for the program by the physician in charge.
Target sample size
30
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 | 05 | Month | 09 | 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 | 08 | Month | 18 | Day |
Date of IRB
| 2021 | Year | 08 | Month | 18 | Day |
Anticipated trial start date
| 2022 | Year | 05 | Month | 09 | 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 | 05 | Month | 02 | Day |
Last modified on
| 2023 | Year | 05 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000054328
