UMIN-CTR Clinical Trial

Basic information
Public title	The effect of subjective proficiency in nursing care on the burden of nursing care of visiting rehabilitation users' families
Acronym	The effect of subjective proficiency in nursing care on the burden of nursing care of visiting rehabilitation users' families
Scientific Title	The effect of subjective proficiency in nursing care on the burden of nursing care of visiting rehabilitation users' families
Scientific Title:Acronym	The effect of subjective proficiency in nursing care on the burden of nursing care of visiting rehabilitation users' families
Region	Japan

Condition
Condition	Home-care recipients using home visit rehabilitation and their primary caregivers
Classification by specialty	Rehabilitation medicine
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	1.To clarify the effect of nursing mastery on the burden of nursing care by the primary caregiver of the visiting rehabilitation user. 2.Clarify the impact of the implementation of visiting rehabilitation on nursing care mastery.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	1.Basic information Persons requiring nursing care: Age, gender, disease name/type, degree of need for nursing care, degree of independence in daily life of elderly with disabilities, degree of independence in daily life of elderly with dementia, presence/absence of outpatient service and frequency of use Primary caregiver: age, gender, relationship with care recipient, number of cohabitants, number of family members who can physically support, care period 2.Implementation status of visit rehabilitation Type of therapist to intervene (physical therapist/occupational therapist/speech therapist), frequency of use (times/week), period from the start of visit rehabilitation 3.Primary caregiver evaluation Caregiver burden: Multidimensional caregiver burden scale (Burden index of caregiver) Care Mastery: Care Mastery Evaluation Positive care feeling: Positive care rating scale Health-related quality of life: SF-8 Health Survey Social Network: Japanese version Lubben Social Network Scale Short version 4.Caregiver evaluation Independence of activities of daily living: Functional Independence Measure Mobility: Functional Ambulation Classification of the Hospital at Sagunto Rivermead Mobility Index Status of activities related to daily life: Frenchay Activities Index
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Maneuver
Interventions/Control_1	Visit rehabilitation
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	40 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Home-care recipients and their primary caregivers who use visiting rehabilitation at each research cooperation facility
Key exclusion criteria	1.If the home-needed caregiver and the primary caregiver are living separately and living alone 2.When the primary caregiver has difficulty answering the questionnaire due to problems with cognitive function or mental state
Target sample size	100

Research contact person
Name of lead principal investigator	1st name tibana Middle name Last name tomohisa
Organization	Kawaguchi Neurosurgery Rehabilitation Clinic
Division name	Department of Rehabilitation
Zip code	573-0086
Address	9-25-202 Koriencho, Hirakata City, Osaka
TEL	0728351010
Email	kawaguchi.ns.reha@gmail.com

Public contact
Name of contact person	1st name tibana Middle name Last name tomohisa
Organization	Kawaguchi Neurosurgery Rehabilitation Clinic
Division name	Department of Rehabilitation
Zip code	573-0086
Address	9-25-202 Koriencho, Hirakata City, Osaka
TEL	0728351010
Homepage URL	https://kawaguchi-ns.com
Email	kawaguchi.ns.reha@gmail.com

Sponsor
Institute	Kawaguchi Neurosurgery Rehabilitation Clinic
Institute
Department

Funding Source
Organization	None
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	Kawaguchi Neurosurgery Rehabilitation Clinic
Address	9-25-202 Koriencho, Hirakata City, Osaka
Tel	0728351010
Email	kawaguchi.ns.reha@gmail.com

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	川口脳神経外科リハビリクリニック（大阪府）、京都きづ川病院　訪問リハビリセンター（京都府）、西大和リハビリテーション病院（奈良県）

Other administrative information
Date of disclosure of the study information	2020 Year 08 Month 10 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	Open public recruiting
Date of protocol fixation	2020 Year 07 Month 14 Day
Date of IRB	2020 Year 07 Month 14 Day
Anticipated trial start date	2020 Year 07 Month 14 Day
Last follow-up date	2021 Year 11 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2020 Year 08 Month 10 Day
Last modified on	2020 Year 08 Month 10 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047231