UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000040986 |
|---|---|
| Receipt number | R000046765 |
| Scientific Title | Effectiveness of personal health records in medical treatment support for patients with chronic diseases |
| Date of disclosure of the study information | 2020/07/15 |
| Last modified on | 2021/07/04 10:38:54 |
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Basic information
Public title
Effectiveness of personal health records in medical treatment support for patients with chronic diseases
Acronym
Effectiveness of personal health records
Scientific Title
Effectiveness of personal health records in medical treatment support for patients with chronic diseases
Scientific Title:Acronym
Effectiveness of personal health records in medical treatment support for patients with chronic diseases
Region
| Japan |
Condition
Condition
diabetes and chronic liver disease
Classification by specialty
| Hepato-biliary-pancreatic medicine | Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
1) Evalustion of the effect of PHR and FGM on the physiological data and patient-reported outcome of diabetes patients
2) Evaluation of the effect of PHR on the parthenogenesis of NASH patients
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Glycemic control of the patients with diabetes and body weight reduction of those with NASH
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Behavior,custom |
Interventions/Control_1
1. Inclusion - 3 month: patient uses PHR App and receives general medical care
2. 4-6 month: 1 and medical care by nurses using PHR data
3. 7-9 month: 1, 2 and medical care by nurses using message function of PHR
4. 10-18 month: general medical care. Use of PHR is up to the patients.
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
| 35 | years-old | <= |
Age-upper limit
| 75 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1. Patients with diabetes and/or NASH who are older than 20 y.o.
2. Diabetes patients who are treated with self-injection (insulin and GLP-1 agonist) and monitored their glucose level using FGM.
3. NASH patients are diagnosed by liver biopsy or imaging exam before inclusion.
Key exclusion criteria
1. Patients who cannot use PHR due to lack of understanding, visual impairment, cognitive impairment and movement disorder of the fingers.
2. Patients who are considered to be impropriety for the participation in this study by physician.
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Keizo |
| Middle name | |
| Last name | Anzai |
Organization
Faculty of Medicine, Saga University
Division name
Metabolism and Endocrinology
Zip code
849-8501
Address
5-1-1 Nabeshima,Saga
TEL
0952-31-6511
akeizo@cc.saga-u.ac.jp
Public contact
Name of contact person
| 1st name | Hirokazu |
| Middle name | |
| Last name | Takahashi |
Organization
Faculty of Medicine, Saga University
Division name
Metabolism and Endocrinology
Zip code
849-8501
Address
5-1-1 Nabeshima,Saga
TEL
0952-31-6511
Homepage URL
takahas2@cc.saga-u.ac.jp
Sponsor or person
Institute
Saga University
Institute
Department
Personal name
Funding Source
Organization
Budget is covered by non-particular research funding of Division of Metabolism and Endocrinology, Saga University.
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Clinical Research Center, Saga University Hospital
Address
5-1-1 Nabeshima,Saga
Tel
0952-34-3400
clinstudycenter@mail.admin.saga-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
| 2020 | Year | 07 | Month | 15 | 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
| 2019 | Year | 12 | Month | 26 | Day |
Date of IRB
| 2020 | Year | 03 | Month | 02 | Day |
Anticipated trial start date
| 2020 | Year | 07 | Month | 15 | 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
| 2020 | Year | 07 | Month | 02 | Day |
Last modified on
| 2021 | Year | 07 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046765
| 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 |
