UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000045166 |
|---|---|
| Receipt number | R000051588 |
| Scientific Title | Elucidation of risk factors for reducing the burden of nursing care in the treatment of intractable diseases |
| Date of disclosure of the study information | 2021/08/16 |
| Last modified on | 2021/08/16 15:35:35 |
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Basic information
Public title
Elucidation of risk factors for reducing the burden of nursing care in the treatment of intractable diseases
Acronym
Elucidation of risk factors in the treatment of intractable diseases
Scientific Title
Elucidation of risk factors for reducing the burden of nursing care in the treatment of intractable diseases
Scientific Title:Acronym
Elucidation of risk factors in the treatment of intractable diseases
Region
| Japan |
Condition
Condition
Neuromuscular disease
Classification by specialty
| Medicine in general | Neurology | Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To identify risk factors for burden of care in patients with neuromuscular diseases living at home.
Basic objectives2
Others
Basic objectives -Others
Identify factors contributing to the burden of care
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Japanese version of the zarit Caregiver Burden Interview-8
Key secondary outcomes
Ikigai-9
Athens Insomnia Scale
Short form Central sensitization inventory
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Family members of those who have a designated medical expenses beneficiary card living in Shimane prefecture.
Consent to participate in the study should be obtained from the patient and caregiver.
Key exclusion criteria
Family members who have a patient who holds a designated medical expense beneficiary certificate but is not caring for the patient
Target sample size
5285
Research contact person
Name of lead principal investigator
| 1st name | Shigeto |
| Middle name | |
| Last name | Moriwaki |
Organization
Shimane University Hospital
Division name
Rehabilitation department
Zip code
693-8501
Address
89-1, Enya cho, Izumo-city, Shimane-Ken
TEL
0853202457
moriwaki@med.shimane-u.ac.jp
Public contact
Name of contact person
| 1st name | Shigeto |
| Middle name | |
| Last name | Moriwaki |
Organization
Shimane University Hospital
Division name
Rehabilitation department
Zip code
6938501
Address
89-1, Enya cho, Izumo-city, Shimane-Ken
TEL
0853-20-2457
Homepage URL
moriwaki@med.shimane-u.ac.jp
Sponsor or person
Institute
Shimane University
Institute
Department
Personal name
Funding Source
Organization
Ministry of education
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Shimane University Medical Research Ethics Committee
Address
89-1, Enyacho, Izumo-shi, Shimane-ken
Tel
0853-20-2515
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
| 2021 | Year | 08 | Month | 16 | 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
| 2021 | Year | 08 | Month | 16 | Day |
Date of IRB
Anticipated trial start date
| 2021 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2023 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
The research design is a case-control study. The survey was a self-administered questionnaire. The target population is Neuromuscular disease. The study period is from September to November 30, 2021. The items to be measured are Zarit8, ikigai-9, AIS, and CSI-9.
Management information
Registered date
| 2021 | Year | 08 | Month | 16 | Day |
Last modified on
| 2021 | Year | 08 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051588
