UMIN-CTR Clinical Trial

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
Email	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
Email	moriwaki@med.shimane-u.ac.jp

Sponsor
Institute	Shimane University
Institute
Department

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
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051588