UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000055943 |
|---|---|
| Receipt number | R000063895 |
| Scientific Title | Feasibility and Efficacy of PHR in Preventing and Managing Progression of Non-Communicable Diseases: Cohort Study |
| Date of disclosure of the study information | 2024/10/25 |
| Last modified on | 2024/12/17 18:25:33 |
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Basic information
Public title
Feasibility and Efficacy of PHR in Preventing and Managing Progression of Non-Communicable Diseases: Cohort Study
Acronym
NCD-PHR Cohort
Scientific Title
Feasibility and Efficacy of PHR in Preventing and Managing Progression of Non-Communicable Diseases: Cohort Study
Scientific Title:Acronym
NCD-PHR Cohort
Region
| Japan |
Condition
Condition
Hypertension, Diabetes Mellitus, Dyslipidemia, Chronic Kidney Disease
Classification by specialty
| Medicine in general | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We will evaluate the feasibility and effectiveness of patient self-management using PHR applications and lifelog monitoring by health care providers in the daily practice of lifestyle-related diseases. In addition, we will accumulate real-world data from patient-reported outcomes (PRO) in the daily practice of lifestyle-related diseases, and further examine the affinity of healthcare professionals for the application. Based on the results, we will construct a dataset that can be utilized at specialized medical institutions (medical care by specialists), in regional cooperation, and at family doctors. This study is an observational, prospective cohort study that have implemented and are practicing PHR applications in their daily practice.
Basic objectives2
Others
Basic objectives -Others
Feasibility of digital monitaring using PHR
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Percentage of participants who started using the PHR application
(Percentage of study participants who have installed and started using the PHR application (completed enrollment)
Key secondary outcomes
One-month retention rate for PHR applications
(Percentage of PHR users whose last day of use was 28 days or more from the date of registration among PHR users whose last day of use was 35 days or more from the date of start of use (date of membership registration))
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) Diagnosis of hypertension, diabetes, dyslipidemia, or chronic kidney disease
2) Age 18 years or older at the time consent is obtained.
3) Written consent to participate in the research has been obtained
Key exclusion criteria
1) Patients who have obvious difficulty operating the PHR application (with or without assistance from family, staff, etc.)
2) Patients who clearly have difficulty assessing their own symptoms due to mental illness or cognitive dysfunction
Target sample size
500
Research contact person
Name of lead principal investigator
| 1st name | Satoshi |
| Middle name | |
| Last name | Taketani |
Organization
Miyakojima Medical Association
Division name
Director
Zip code
534-0021
Address
2-16-11, Miyako-jima Hondori, Miyako-jima-ku, Osaka City, Osaka, Japan
TEL
06-6922-7781
taketani@pp.iij4u.or.jp
Public contact
Name of contact person
| 1st name | Akihito |
| Middle name | |
| Last name | Iokawa |
Organization
Welby, Inc.
Division name
Account Sales Div.
Zip code
1040031
Address
1-11-1 Kyobashi, Chuo-ku, Tokyo, Japan
TEL
03-6206-2937
Homepage URL
akihito.iokawa@welby.jp
Sponsor or person
Institute
Miyako-jima-ku Medical Association
Institute
Department
Personal name
Funding Source
Organization
Ministry of Economy, Trade and Industry
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
Japan Physicians Association
Address
2-5 Kanda Surugadai, Chiyoda-ku, Tokyo
Tel
03-3259-6111
jpa@nichirinnai.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
竹谷クリニック（大阪府）
大阪市立総合医療センター（大阪府）
泉岡医院 （大阪府）
武内小児科・内科（大阪府）
柏井内科（大阪府）
やぎクリニック（大阪府）
尽生会聖和病院（大阪府）
安芸医院（大阪府）
福愛会いんべ診療所（大阪府）
かわい内科・胃腸内科クリニック（大阪府）
おたきクリニック（大阪府）
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 10 | Month | 25 | 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
| 2024 | Year | 08 | Month | 07 | Day |
Date of IRB
| 2024 | Year | 08 | Month | 29 | Day |
Anticipated trial start date
| 2024 | Year | 10 | Month | 28 | Day |
Last follow-up date
| 2030 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Observation Plan
Information regarding the use of the PHR (Personal Health Record) application will be provided to study participants. This information will be delivered through explanations by attending physicians or medical staff, as well as through an introduction video about the PHR. The actual use of the PHR application will be left to the free will of the study participants.
For patients who use the PHR application, it is recommended that medical providers check the information recorded by the patient in the PHR application before or during the consultation as part of routine medical care. Additionally, it is recommended that medical providers utilize this information during the consultation to provide necessary information and guidance. The operational methods of using the PHR application in routine clinical practice are described in the "Welby Administrator Manual (Healthcare Provider Interface)," and the specific operational details will be left to the discretion of the participating medical institutions.
No additional interventions will be implemented as part of participation in this study; however, as an observational study, the data recorded in the PHR application will also be collected and analyzed as research data.
Management information
Registered date
| 2024 | Year | 10 | Month | 25 | Day |
Last modified on
| 2024 | Year | 12 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000063895
