UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000050483 |
|---|---|
| Receipt number | R000057508 |
| Scientific Title | The anxiety factors in patients admitted to convalescent rehabilitation wards. |
| Date of disclosure of the study information | 2023/03/03 |
| Last modified on | 2023/03/03 19:30:50 |
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Basic information
Public title
The anxiety factors in patients admitted to convalescent rehabilitation wards.
Acronym
The anxiety factors in patients admitted to convalescent rehabilitation wards.
Scientific Title
The anxiety factors in patients admitted to convalescent rehabilitation wards.
Scientific Title:Acronym
The anxiety factors in patients admitted to convalescent rehabilitation wards.
Region
| Japan |
Condition
Condition
cerebrovascular disease, musculoskeletal disease, etc.
The diseases eligible for admission to the convalescent rehabilitation wards.
Classification by specialty
| Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the anxiety factors of patients admitted to a convalescent rehabilitation ward using qualitative methods and to examine their coping strategies.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The number of clusters of anxiety factors, and their contents.
Key secondary outcomes
The number of clusters of intervention methods, and contents.
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
(Patients subjects)
1. Patients admitted to the convalescent rehabilitation wards.
2. Consent to participate in the study.
(Medical staff subjects)
1. Worked in a convalescent rehabilitation ward for at least 1 year.
2. Consent to participate in the study.
Key exclusion criteria
(Patients subjects)
1. Inability to fully comprehend the interview contents.
2. Cognitive impairment or higher brain dysfunction that interferes with the interview.
(Medical staff subjects)
1. Subjects deemed inappropriate by the Principal Investigator or Research Supervisor.
Target sample size
55
Research contact person
Name of lead principal investigator
| 1st name | Yohei |
| Middle name | |
| Last name | Otaka |
Organization
Fujita Health University School of Medicine
Division name
Department of Rehabilitation Medicine I
Zip code
470-1192
Address
1-98, Dengakugakubo, Kutsukake-cho, Toyoake, Aichi
TEL
0562-93-2167
otaka119@mac.com
Public contact
Name of contact person
| 1st name | Taiki |
| Middle name | |
| Last name | Yoshida |
Organization
Fujita Health University
Division name
Faculty of Rehabilitation, School of Health Sciences
Zip code
470-1192
Address
1-98, Dengakugakubo, Kutsukake-cho, Toyoake, Aichi
TEL
0562-93-9000
Homepage URL
taiki.yoshida@fujita-hu.ac.jp
Sponsor or person
Institute
Fujita Health University
Institute
Department
Personal name
Funding Source
Organization
Fujita Health University
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
Ethics Review Committee of Fujita Health University
Address
1-98 Dengakugakubo, Kutukake-cho, Toyoake, Aichi
Tel
0562-93-2865
f-irb@fujita-hu.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
藤田医科大学（愛知県）
Other administrative information
Date of disclosure of the study information
| 2023 | Year | 03 | Month | 03 | 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
Enrolling by invitation
Date of protocol fixation
| 2022 | Year | 11 | Month | 28 | Day |
Date of IRB
| 2023 | Year | 01 | Month | 17 | Day |
Anticipated trial start date
| 2023 | Year | 01 | Month | 17 | Day |
Last follow-up date
| 2027 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2027 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2027 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2027 | Year | 03 | Month | 31 | Day |
Other
Other related information
To investigate the anxiety factors of patients admitted to convalescent rehabilitation wards using qualitative methods, and to examine their coping strategies.
Management information
Registered date
| 2023 | Year | 03 | Month | 03 | Day |
Last modified on
| 2023 | Year | 03 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000057508
