UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000052225 |
|---|---|
| Receipt number | R000059608 |
| Scientific Title | Digital Health Readiness Questionnaire Japanese study |
| Date of disclosure of the study information | 2023/10/31 |
| Last modified on | 2024/01/29 23:59:33 |
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Basic information
Public title
Digital Health Readiness Questionnaire Japanese study
Acronym
DHRQx Japanese study
Scientific Title
Digital Health Readiness Questionnaire Japanese study
Scientific Title:Acronym
DHRQx Japanese study
Region
| Japan |
Condition
Condition
Cardiovascular diseases
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
A Digital Health Readiness Questionnaire was developed in Europe, showed good internal validity, and was published. However, it is not clear whether the questionnaire can be adapted outside Europe. In this study, the authors translated the questionnaire into Japanese, administered it in Japan, interpreted the results, and verified whether the questionnaire is valid in Japan.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Scores for each item in the Digital Health Readiness Questionnaire and their total scores
Key secondary outcomes
Evaluation of model fit, construct reliability, and construct validity of the questionnaire in our country
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Other |
Interventions/Control_1
Filling out the Digital Health Readiness Questionnaire
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
Patients 18 years of age or older who are outpatients with a diagnosis of cardiovascular diseases
Key exclusion criteria
1) Patients who are unable to give their written consent
2) Patients who are unable to fill out the questionnaire on their own
3) Other patients who are judged to be inappropriate for the study by the physician in charge
Target sample size
210
Research contact person
Name of lead principal investigator
| 1st name | Toshiki |
| Middle name | |
| Last name | Kaihara |
Organization
St. Marianna University Hospital
Division name
Department of Cardiology
Zip code
216-8511
Address
2-16-1, Sugao, Miyamae-ku, Kawasaki, Kanagawa
TEL
0449778111
tk-presen2@marianna-u.ac.jp
Public contact
Name of contact person
| 1st name | Toshiki |
| Middle name | |
| Last name | Kaihara |
Organization
St. Marianna University Hospital
Division name
Department of Cardiology
Zip code
216-8511
Address
2-16-1, Sugao, Miyamae-ku, Kawasaki, Kanagawa
TEL
0449778111
Homepage URL
tk-presen2@marianna-u.ac.jp
Sponsor or person
Institute
St. Marianna University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
St. Marianna University School of Medicine
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
St. Marianna University School of Medicine
Address
2-16-1, Sugao, Miyamae-ku, Kawasaki, Kanagawa
Tel
0449778111
k-sienbu.mail@marianna-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
| 2023 | Year | 10 | Month | 31 | 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
210
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
Completed
Date of protocol fixation
| 2023 | Year | 09 | Month | 15 | Day |
Date of IRB
| 2023 | Year | 10 | Month | 23 | Day |
Anticipated trial start date
| 2023 | Year | 10 | Month | 31 | Day |
Last follow-up date
| 2023 | Year | 12 | 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
| 2023 | Year | 09 | Month | 16 | Day |
Last modified on
| 2024 | Year | 01 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000059608
