UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000049251 |
|---|---|
| Receipt number | R000056073 |
| Scientific Title | Study of usefulness of ePRO in cardiovascular disease |
| Date of disclosure of the study information | 2022/10/19 |
| Last modified on | 2023/10/20 22:12:30 |
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Basic information
Public title
Study of usefulness of ePRO in cardiovascular disease
Acronym
Study of usefulness of ePRO in cardiovascular disease
Scientific Title
Study of usefulness of ePRO in cardiovascular disease
Scientific Title:Acronym
Study of usefulness of ePRO in cardiovascular disease
Region
| Japan |
Condition
Condition
cardiovascular disease
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine whether visualizing patient symptoms with electric patient-reported outcomes (ePRO) for patients with cardiovascular disease improves patient satisfaction.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Satisfaction using Likert scale
Key secondary outcomes
Assessment of patient well-being, and patient preferences for shared decision making using questionnaires
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
After explaining the research, consent will be obtained with an electronic signature. After that, you will be asked to answer 1 pre-questionnaire in writing, a total of 5 questionnaires on ePRO, and 1 post-questionnaire in writing at the end of the observation.
Interventions/Control_2
After explaining the research, consent will be obtained with an electronic signature. After that, you will be asked to answer one written pre-questionnaire and one written post-questionnaire at the end of the observation.
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.Adults over 18 years of age with outpatient cardiovascular disease
2. Previous catheterization for angina pectoris/myocardial infarction, heart failure meeting the Framingham criteria and (at enrollment) BNP >100 pg/ml on blood draw, atrial Patients with atrial fibrillation detected by 12-lead ECG
Key exclusion criteria
1.Patients who are judged to be inappropriate for this study by the research representative/co-investigators
2.Patients who cannot operate electronic devices such as tablets
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Jinzaki |
| Middle name | |
| Last name | Masahiro |
Organization
Keio University
Division name
School of Medicine, Department of Diagnostic Radiology
Zip code
160-0016
Address
35 Shinanomachi, Shinjuku-ku, Tokyo 160-8582 Japan
TEL
03-3353-1211
jinzaki@rad.med.keio.ac.jp
Public contact
Name of contact person
| 1st name | Katsumata |
| Middle name | |
| Last name | Yoshinori |
Organization
Keio University
Division name
School of Medicine, Institute for Integrated Sports Medicine
Zip code
160-0016
Address
35 Shinanomachi, Shinjuku-ku, Tokyo 160-8582 Japan
TEL
03-5269-9054
Homepage URL
goodcentury21@keio.jp
Sponsor or person
Institute
Keio University
Institute
Department
Personal name
Funding Source
Organization
none
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
Keio University School of Medicine
Address
35 Shinanomachi, Shinjuku-ku, Tokyo 160-8582 Japan
Tel
03-5363-3503
med-rinri-jimu@adst.keio.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
産業医科大学（福岡県）、日野市立病院（東京都）、国立病院機構埼玉病院（埼玉県）
Other administrative information
Date of disclosure of the study information
| 2022 | Year | 10 | Month | 19 | 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
50
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
| 2022 | Year | 10 | Month | 06 | Day |
Date of IRB
| 2022 | Year | 10 | Month | 14 | Day |
Anticipated trial start date
| 2022 | Year | 11 | Month | 04 | Day |
Last follow-up date
| 2024 | 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
| 2022 | Year | 10 | Month | 18 | Day |
Last modified on
| 2023 | Year | 10 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000056073
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
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| Registered date | File name |
