UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000026738 |
|---|---|
| Receipt number | R000030696 |
| Scientific Title | An open-label, randomized, parallel-group comparison study on the effects of using PHR "e-DM Diary" on self-care ability in Diabetes patients |
| Date of disclosure of the study information | 2017/03/30 |
| Last modified on | 2017/03/30 09:10:29 |
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Basic information
Public title
An open-label, randomized, parallel-group comparison study on the effects of using PHR "e-DM Diary" on self-care ability in Diabetes patients
Acronym
The effects on the self-care ability of using PHR "e-DM Diary" in Diabetes patients
Scientific Title
An open-label, randomized, parallel-group comparison study on the effects of using PHR "e-DM Diary" on self-care ability in Diabetes patients
Scientific Title:Acronym
The effects on the self-care ability of using PHR "e-DM Diary" in Diabetes patients
Region
| Japan |
Condition
Condition
40 diabetics who use their smartphones daily
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The objectives is to use the PHR "e-DM Diary" in diabetes care, and measure the effects on diabetes state and self-care.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Measure changes in the diabetes state (HbA1c, weight) after using e-DM Diary for 2 months and 4 months.
Key secondary outcomes
Measure changes in the following items after using e-DM Diary for 2 months and 4 months: Self-care(The Summary of Diabetes Self-care Activities Measure), patient's empowerment state(Diabetes Empowerment Scale-Short Form), usability of e-DM Diary (Evaluated usability and assessment criteria for diabetes apps for the elderly), knowledge of treatment goals and progress
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Cluster
Blinding
Open -no one is blinded
Control
Active
Stratification
YES
Dynamic allocation
YES
Institution consideration
Institution is not considered as adjustment factor.
Blocking
YES
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
There is no internvention for the 1st month, and the clinical test data will be taken for comparison.
During the next monthly clinic visit after providing consent, the patient will be provided a e-DM Diary account, self-monitoring devices(digital scale, BP monitor, activity monitor, blood glucose monitor). The patient will be instructed to use these for their self-care for 4 months.
At 2 months and 4 months of e-DM Diary, clinical test data will be obtained and questionaire will be conducted.
At the end of the study, an additional interview on the usability of e-DM Diary will be conducted.
Interventions/Control_2
There is no internvention for the 1st month, and the clinical test data will be taken for comparison.
During the next monthly clinic visit after providing consent, the patient will be provided self-monitoring devices(digital scale, BP monitor, activity monitor, blood glucose monitor) and standard paper logbooks. The patient will be instructed to use these for their self-care for 2 months.
After the 2 months, an e-DM Diary account will be provided. The patient will be instructed to use these for their self-care for the next 2 months.
At 2 months and 4 months of intervention, clinical test data will be obtained and questionaire will be conducted.
At the end of the study, an additional interview on the usability of e-DM Diary will be conducted.
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
| 80 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Has been diagnosed with diabetes
Uses smartphones daily
Has given written consent to participate in the research
Key exclusion criteria
Those whose HbA1c has worsen by more than 1% over the last 3 months, and/or has failed to reach treatment goals and assessed to need immediate care.
Those who are undergoing intensive cardio-vascular, cerebrovascular and kindney disease treatment.
Those who are participating in other interventional clinical trials
Those for other reasons, who have been assessed to be not fit by their doctor,
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Munehide Matsuhisa |
Organization
Tokushima University
Division name
Diabetes Therapeutics and Research Center, Institute of Advanced Medical Sciences
Zip code
Address
3-8-15 Kuramoto-cho, Tokushima-city
TEL
088-633-7587
matuhisa@tokushima-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Satoshi Taniguchi |
Organization
Tokushima University
Division name
Diabetes Therapeutics and Research Center, Institute of Advanced Medical Sciences
Zip code
Address
3-8-15 Kuramoto-cho, Tokushima-city
TEL
088-633-7587
Homepage URL
satoshi.taniguchi@tokushima-u.ac.jp
Sponsor or person
Institute
Tokushima University
Institute
Department
Personal name
Funding Source
Organization
Ministry of Internal Affairs and Communications
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
Ministry of Education, Culture, Sports, Science and Technology
Welby Inc
ARKRAY Inc
IRB Contact (For public release)
Organization
Address
Tel
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
徳島大学病院(徳島県），徳島県立中央病院(徳島県），徳島県鳴門病院(徳島県），たまき青空病院(徳島県）
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 03 | Month | 30 | 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
Preinitiation
Date of protocol fixation
| 2017 | Year | 03 | Month | 13 | Day |
Date of IRB
Anticipated trial start date
| 2017 | Year | 05 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2017 | Year | 03 | Month | 28 | Day |
Last modified on
| 2017 | Year | 03 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030696
