UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000041369 |
|---|---|
| Receipt number | R000047231 |
| Scientific Title | The effect of subjective proficiency in nursing care on the burden of nursing care of visiting rehabilitation users' families |
| Date of disclosure of the study information | 2020/08/10 |
| Last modified on | 2020/08/10 11:05:25 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
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
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
kawaguchi.ns.reha@gmail.com
Sponsor or person
Institute
Kawaguchi Neurosurgery Rehabilitation Clinic
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047231
