UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000055483 |
|---|---|
| Receipt number | R000061035 |
| Scientific Title | What are the key factors in the prevention and treatment of delirium in hospitalized heart failure patients? -For the development of delirium prevention programs for heart failure patients |
| Date of disclosure of the study information | 2024/09/11 |
| Last modified on | 2025/07/11 10:14:22 |
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Basic information
Public title
What are the key factors in the prevention and treatment of delirium in hospitalized heart failure patients?
-For the development of delirium prevention programs for heart failure patients
Acronym
What are the key factors in the prevention and treatment of delirium in hospitalized heart failure patients?
-For the development of delirium prevention programs for heart failure patients
Scientific Title
What are the key factors in the prevention and treatment of delirium in hospitalized heart failure patients?
-For the development of delirium prevention programs for heart failure patients
Scientific Title:Acronym
What are the key factors in the prevention and treatment of delirium in hospitalized heart failure patients?
-For the development of delirium prevention programs for heart failure patients
Region
| Japan |
Condition
Condition
Heart failure
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To identify important factors in heart failure patients based on a general program of prevention and treatment of delirium in hospitalized patients, based on interviews with health care professionals involved in the treatment of heart failure, and to obtain suggestions for the development of a delirium prevention program for hospitalized heart failure patients.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Factors to focus on in heart failure in a delirium prevention and treatment program
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Medical professionals (physicians, nurses, physical therapists, occupational therapists, etc.) who are routinely involved in the treatment of heart failure and have at least 10 years of clinical experience and who have obtained the consent of the applicant.
Key exclusion criteria
Persons deemed unsuitable as subjects by the principal investigator
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Risa |
| Middle name | |
| Last name | Otsuka |
Organization
Shinshu university
Division name
Department of Health Science
Zip code
390-8621
Address
Matsumoto, Nagano
TEL
0263372401
2r022otsuka4@shinshu-u.ac.jp
Public contact
Name of contact person
| 1st name | Risa |
| Middle name | |
| Last name | Otsuka |
Organization
Shinshu university
Division name
Department of Health Science
Zip code
399-8621
Address
Matsumoto, Nagano
TEL
0263372401
Homepage URL
2r022otsuka4@shinshu-u.ac.jp
Sponsor or person
Institute
Shinshu 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
Shinshu university
Address
Matsumoto, Nagano
Tel
0263372401
2r022otsuka4@shinshu-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
| 2024 | Year | 09 | Month | 11 | 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
9
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 | 08 | Month | 22 | Day |
Date of IRB
| 2023 | Year | 08 | Month | 22 | Day |
Anticipated trial start date
| 2023 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2024 | Year | 04 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
A semi-structured interview will be conducted with healthcare professionals skilled in heart failure (physicians, nurses, and rehabilitation professionals) to elicit and qualitatively analyze the factors that are important as delirium prevention in elderly heart failure patients.
Management information
Registered date
| 2024 | Year | 09 | Month | 11 | Day |
Last modified on
| 2025 | Year | 07 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000061035
