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

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 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

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

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051588


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name