UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000060984 |
|---|---|
| Receipt number | R000069784 |
| Scientific Title | Observational Study on Support for Treatment-Work Balance among Patients with Cardiovascular Diseases in Shimane University Hospital |
| Date of disclosure of the study information | 2026/03/19 |
| Last modified on | 2026/03/19 11:56:14 |
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Basic information
Public title
Observational Study on Support for Treatment-Work Balance among Patients with Cardiovascular Diseases in Shimane University Hospital
Acronym
Observational Study on Support for Treatment-Work Balance among Patients with Cardiovascular Diseases in Shimane University Hospital
Scientific Title
Observational Study on Support for Treatment-Work Balance among Patients with Cardiovascular Diseases in Shimane University Hospital
Scientific Title:Acronym
TWB-Shimane
Region
| Japan |
Condition
Condition
Cardiovascular Diseases
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To identify the current status of comprehensive support for balancing treatment and work provided to patients with cardiovascular disease.
Basic objectives2
Others
Basic objectives -Others
Identification of factors associated with continued employment after discharge.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The return-to-work rate at 1 year after discharge.
Key secondary outcomes
(1) Work-related measures: Contents of the employment-related questionnaire, International Physical Activity Questionnaire, Work Productivity and Activity Questionnaire, and the Brief Job Stress Questionnaire
(2) Clinical outcomes: All-cause mortality, cardiovascular mortality, all-cause readmission, heart failure readmission, unscheduled visits, and major adverse cardiovascular events (MACE: a composite of cardiovascular death, myocardial infarction, and stroke)
(3) Physical function and quality of life (QOL): Changes in the Clinical Frailty Scale, changes in the Barthel Index, changes in the European Heart Failure Self-Care Behavior Scale Japanese version, and changes in the EQ-5D-5L
(4) Exploration of factors associated with return to work and work retention: Patient background, treatment details for cardiovascular disease, clinical findings, laboratory findings, findings from exercise function tests, and contents of multidisciplinary conferences
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) Patients aged >=18 years at the time of obtaining informed consent (regardless of sex).
2) Patients admitted to the Department of Cardiovascular Medicine at Shimane University Hospital for evaluation and treatment of acute coronary syndrome, acute heart failure, valvular heart disease, arrhythmia, or cardiomyopathy.
3) Patients who were engaged in some form of employment prior to admission (including full-time employment, part-time/non-regular employment, or self-employment), or who express a desire to work after discharge.
4) Patients who, after receiving a full explanation of the study and demonstrating sufficient understanding, provide written informed consent of their own free will to participate in this study.
Key exclusion criteria
1) Patients admitted solely for planned treatments (e.g., elective PCI, ablation, TAVI, MitraClip) or for diagnostic evaluation.
2)Patients in whom continuation of employment is considered medically difficult due to severe comorbidities, progressive malignancy, end-stage renal failure, or similar conditions.
3) Patients for whom completion of questionnaires or follow-up is difficult due to advanced dementia or severe psychiatric disorders.
4) Patients whom the attending physician judges to have a life expectancy of less than 6 months at the time of study enrollment.
5) Patients expected to relocate overseas, be lost to follow-up (e.g., unknown contact information), or require prolonged hospitalization.
6) Patients deemed inappropriate for participation in this study by the attending physician or the principal investigator for any other reason.
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Junya |
| Middle name | |
| Last name | Tanabe |
Organization
Shimane University Faculty of Medicine
Division name
Cardiology
Zip code
693-8501
Address
89-1 Enya-cho, Izumo, Shimane, Japan
TEL
0853202249
jtanabe@med.shimane-u.ac.jp
Public contact
Name of contact person
| 1st name | Junya |
| Middle name | |
| Last name | Tanabe |
Organization
Shimane University Faculty of Medicine
Division name
Cardiology
Zip code
693-8501
Address
89-1 Enya-cho, Izumo, Shimane, Japan
TEL
0853202249
Homepage URL
jtanabe@med.shimane-u.ac.jp
Sponsor or person
Institute
Shimane University Faculty of Medicine
Institute
Department
Personal name
Funding Source
Organization
None
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
Medical Research Ethics Committee, Shimane University Faculty of Medicine
Address
89-1 Enya-cho, Izumo, Shimane, Japan
Tel
0853202515
kenkyu@med.shimane-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
| 2026 | Year | 03 | 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
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
Preinitiation
Date of protocol fixation
| 2026 | Year | 03 | Month | 20 | Day |
Date of IRB
Anticipated trial start date
| 2026 | Year | 03 | Month | 23 | Day |
Last follow-up date
| 2029 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Before the start of the study.
Management information
Registered date
| 2026 | Year | 03 | Month | 19 | Day |
Last modified on
| 2026 | Year | 03 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000069784
