UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000047055 |
|---|---|
| Receipt number | R000053599 |
| Scientific Title | Patient Survey on Burdens, Perceptions, Self-care and Treatment Support of Living with Heart Failure in Japan |
| Date of disclosure of the study information | 2022/03/01 |
| Last modified on | 2022/12/15 19:04:26 |
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Basic information
Public title
Patient Survey on Burdens, Perceptions, Self-care and Treatment Support of Living with Heart Failure in Japan
Acronym
Heart Failure Patient Burdens and Perceptions in Japan
Scientific Title
Patient Survey on Burdens, Perceptions, Self-care and Treatment Support of Living with Heart Failure in Japan
Scientific Title:Acronym
Heart Failure Patient Burdens and Perceptions in Japan
Region
| Japan |
Condition
Condition
Chronic Heart Failure
Classification by specialty
| Medicine in general | Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To understand how patients with chronic heart failure have experienced diseases including comorbidities and associated physical and emotional burdens, and how they perceive information about the diseases, self-care and treatment support in daily life. In addition, to elicit feedback on clinical trial participation if patients have experienced it.
Basic objectives2
Others
Basic objectives -Others
To understand how patients with chronic heart failure have experienced diseases including comorbidities and associated physical and emotional burdens, and how they perceive information about the diseases, self-care and treatment support in daily life. In addition, to elicit feedback on clinical trial participation if patients have experienced it.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Patient demographics, condition of heart failure, comorbidities, pathway to heart failure treatment, physical and emotional burdens associated with heart failure, information of disease, self-care and support for treatment in daily life, experience in clinical trial
Key secondary outcomes
Base
Study type
Others,meta-analysis etc
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) Patients with diagnosis of chronic heart failure
2) 18 years of age or older
Key exclusion criteria
1) Inability to provide informed consent or complete the survey at treating physician's discretion
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Nobutaka |
| Middle name | |
| Last name | Yagi |
Organization
Nippon Boehringer Ingelheim Co., Ltd.
Division name
Patient Advocacy Relations Medical Advisor Medicine Division
Zip code
141-6017
Address
2-1-1 Osaki, Shinagawa-ku,Tokyo, JAPAN
TEL
03-6417-2043
nobutaka.yagi@boehringer-ingelheim.com
Public contact
Name of contact person
| 1st name | Nobutaka |
| Middle name | |
| Last name | Yagi |
Organization
Nippon Boehringer Ingelheim Co., Ltd.
Division name
Patient Advocacy Relations Medical Advisor Medicine Division
Zip code
141-6017
Address
2-1-1 Osaki, Shinagawa-ku,Tokyo, JAPAN
TEL
0364172043
Homepage URL
nobutaka.yagi@boehringer-ingelheim.com
Sponsor or person
Institute
Nippon Boehringer Ingelheim Co., Ltd.
Institute
Department
Personal name
Funding Source
Organization
Nippon Boehringer Ingelheim Co., Ltd.
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
-
Address
-
Tel
06-4797-5660
kanri@ml.amc-clinic.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
| 2022 | Year | 03 | Month | 01 | 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
Completed
Date of protocol fixation
| 2022 | Year | 02 | Month | 17 | Day |
Date of IRB
| 2022 | Year | 03 | Month | 04 | Day |
Anticipated trial start date
| 2022 | Year | 03 | Month | 30 | Day |
Last follow-up date
| 2022 | Year | 07 | 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 | 03 | Month | 01 | Day |
Last modified on
| 2022 | Year | 12 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053599
