UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000054681 |
|---|---|
| Receipt number | R000062487 |
| Scientific Title | Effectiveness of Lifestyle Guidance Using a Personal Health Records (PHR) Information Sharing System for Outpatients with noncommunicable diseases: A Randomized Controlled Trial |
| Date of disclosure of the study information | 2024/06/30 |
| Last modified on | 2025/06/18 11:02:59 |
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Basic information
Public title
Verification of Effectiveness of Lifestyle Guidance Using Personal Health Records (PHR) Information Sharing System for Outpatients with noncommunicable diseases
Acronym
Verification of Effectiveness of Lifestyle Guidance Using PHR Information Sharing System for Outpatients with noncommunicable diseases
Scientific Title
Effectiveness of Lifestyle Guidance Using a Personal Health Records (PHR) Information Sharing System for Outpatients with noncommunicable diseases: A Randomized Controlled Trial
Scientific Title:Acronym
Effectiveness of Lifestyle Guidance Using PHR Information Sharing System for Outpatients with noncommunicable diseases: RCT
Region
| Japan |
Condition
Condition
noncommunicable diseases
Classification by specialty
| Medicine in general |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify the effectiveness of lifestyle guidance for outpatients using the PHR information sharing system.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Amount of change in number of steps (difference in average number of steps per day between before and after the intervention period)
Key secondary outcomes
Change in weight, blood pressure, and number of measurements (difference in average per day before and after the intervention period, as well as frequency and input of data)
Changes in exercise habits, lifestyle, and subjective sense of health
Change in scale measuring trust in physicians
Net Promoter Score
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
Active
Stratification
YES
Dynamic allocation
NO
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
| Behavior,custom |
Interventions/Control_1
Lifestyle Guidance Using PHR Information Sharing System
Interventions/Control_2
General Lifestyle Guidance
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
| 40 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Those who plan to visit an outpatient clinic once every 1-2 months for treatment of noncommunicable diseases (diabetes, hypertension, dyslipidemia.)
Persons 40 years old or older
Have the cognitive ability to install the necessary applications on their smartphones and input data
Persons who have a habit of carrying a smartphone with them when they go out every day and is able to collect step data.
Key exclusion criteria
Persons for whom the attending physician determines that it is unnecessary or inappropriate to provide lifestyle guidance related to activity level, such as walking, in the medical examination.
Those who are expected to end their visits to their primary care physician during the intervention and survey periods (approximately 7 months in total) (e.g., those who plan to move to a new location)
Those who have impairments or limitations in walking function, such as inability or difficulty walking.
Persons who are deemed by their attending physician to be inappropriate to participate in the study
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Yoshimitsu |
| Middle name | |
| Last name | TAKAHASHI |
Organization
Kyoto University School of Public Health
Division name
Department of Health Informatics
Zip code
606-8501
Address
Yoshida Konoe-cho, Sakyo-ku, Kyoto-shi, Kyoto 202, Building G, School of Medicine
TEL
075-753-9477
takahashi.yoshimitsu.3m@kyoto-u.ac.jp
Public contact
Name of contact person
| 1st name | Yu |
| Middle name | |
| Last name | FUJIMOTO |
Organization
Kyoto University School of Public Health
Division name
Department of Health Informatics
Zip code
606-8501
Address
Yoshida Konoe-cho, Sakyo-ku, Kyoto-shi, Kyoto 202, Building G, School of Medicine
TEL
075-753-9477
Homepage URL
fujimoto.yu.68p@st.kyoto-u.ac.jp
Sponsor or person
Institute
Kyoto University
Institute
Department
Personal name
Funding Source
Organization
Japan Agency for Medical Research and Development
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Nakatani Internal Medicine Clinic
Seikohkai Hospital
Kusaka Hospital
Matsushita Memorial Hospital
Kyoto Saiseikai Hospital
University Hospital Kyoto Prefectural University of Medicine
Hatoko Clinic
Ojima Clinic
Hino Memorial Hospital
Kawakita Family Clinic Minami-Asagaya
Handa Family Clinic
Kyoto Min-iren Asukai Hospital
Seta Clinic
Nobumasa Clinic
Rakuwakai Otowa Hospital
Yodo Sansenkai Kanai Hospital
Takayama Hospital
Hoshino Mori Gastroenterology Clinic
Rokkaku Tanaka Clinic
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kyoto University Graduate School and Faculty of Medicine, Ethics Committee
Address
Yoshida-Konoe-cho, Sakyo-ku, Kyoto
Tel
075-753-4680
ethcom@kuhp.kyoto-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
中谷内科医院（長野県）
正幸会病院（大阪府）
日下病院（三重県）
松下記念病院（大阪府）
京都済生会病院（京都府）
京都府立医科大学附属病院（京都府）
はとこクリニック（奈良県）
小嶋医院（兵庫県）
日野記念病院（滋賀県）
河北ファミリークリニック南阿佐谷（東京都）
半田ファミリークリニック（愛知県）
京都民医連あすかい病院（京都府）
せたクリニック（和歌山県）
のぶまさクリニック（京都府）
洛和会音羽病院（京都府）
淀さんせん会 金井病院（京都府）
高山病院（和歌山県）
星の森消化器内科クリニック（和歌山県）
六角田中クリニック（京都府）
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 06 | 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
212
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
| 2024 | Year | 04 | Month | 01 | Day |
Date of IRB
| 2024 | Year | 07 | Month | 02 | Day |
Anticipated trial start date
| 2024 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2026 | 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
| 2024 | Year | 06 | Month | 17 | Day |
Last modified on
| 2025 | Year | 06 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000062487
