UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000055487 |
|---|---|
| Receipt number | R000063400 |
| Scientific Title | A qualitative study of what skilled occupational therapists believe are important elements in the occupational therapy of heart failure patients for the development of occupational therapy programs for hospitalized heart failure patients. |
| Date of disclosure of the study information | 2024/09/11 |
| Last modified on | 2025/07/11 10:15:49 |
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Basic information
Public title
What are the key elements in occupational therapy for heart failure patients - Toward the development of effective occupational therapy programs for hospitalized heart failure patients?
Acronym
What are the key elements in occupational therapy for heart failure patients
Scientific Title
A qualitative study of what skilled occupational therapists believe are important elements in the occupational therapy of heart failure patients for the development of occupational therapy programs for hospitalized heart failure patients.
Scientific Title:Acronym
What are the key elements of occupational therapy for heart failure patients in the opinion of a skilled occupational therapist?
Region
| Japan |
Condition
Condition
Occupational therapists
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The important factors (viewpoint, evaluation, and intervention) in occupational therapy for hospitalized heart failure patients were clarified through interviews with occupational therapists involved in the treatment of hospitalized heart failure, and suggestions were obtained for the development of effective occupational therapy programs for hospitalized heart failure patients.
Basic objectives2
Others
Basic objectives -Others
What elements should be included in an occupational therapy program for hospitalized heart failure patients?
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
What are the key elements in occupational therapy for hospitalized heart failure patients?
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
Occupational therapists who have at least five years of experience in providing occupational therapy to hospitalized heart failure patients, and who are still providing occupational therapy to hospitalized heart failure patients on a daily basis
Key exclusion criteria
Persons deemed unsuitable as subjects by the principal investigator
Target sample size
24
Research contact person
Name of lead principal investigator
| 1st name | Risa |
| Middle name | |
| Last name | Otsuka |
Organization
Shinshu university
Division name
School of health sciences
Zip code
390-8621
Address
3-1-1, Asahi, Matsumoto, Nagano, Japan
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
School of health sciences
Zip code
3908621
Address
3-1-1, Asahi, Matsumoto, Nagano, Japan
TEL
0263372401
Homepage URL
2r022otsuka4@shinshu-u.ac.jp
Sponsor or person
Institute
Shinshu university
Institute
Department
Personal name
Funding Source
Organization
Shinshu university
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
Shinshu university
Address
3-1-1, Asahi, Matsumoto, Nagano, Japan
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
15
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
| 2024 | Year | 08 | Month | 06 | Day |
Date of IRB
| 2024 | Year | 08 | Month | 06 | Day |
Anticipated trial start date
| 2024 | Year | 08 | Month | 06 | Day |
Last follow-up date
| 2026 | Year | 03 | Month | 31 | 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 used to survey occupational therapists to identify important factors in the occupational therapy of heart failure patients, and a thematic analysis will be used to identify important factors in the occupational therapy of 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=R000063400
