UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000055725 |
|---|---|
| Receipt number | R000063685 |
| Scientific Title | An exploratory study of the benefits of home-visit rehabilitation as perceived by family caregivers of persons requiring severe nursing care. |
| Date of disclosure of the study information | 2024/10/03 |
| Last modified on | 2024/10/03 16:45:58 |
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Basic information
Public title
An exploratory study of the benefits of home-visit rehabilitation as perceived by family caregivers of persons requiring severe nursing care.
Acronym
An exploratory study of the benefits of home-visit rehabilitation as perceived by family caregivers of persons requiring severe nursing care.
Scientific Title
An exploratory study of the benefits of home-visit rehabilitation as perceived by family caregivers of persons requiring severe nursing care.
Scientific Title:Acronym
An exploratory study of the benefits of home-visit rehabilitation as perceived by family caregivers of persons requiring severe nursing care.
Region
| Japan |
Condition
Condition
The target is 1 to 5 family caregivers who were mainly responsible for caring for home-visit rehabilitation users who meet the following conditions. 1. The home-visit rehabilitation user's bedridden level is B1/B2 or C1/C2 1. The home-visit rehabilitation user's level of independence in daily living for the elderly with dementia is III, IV, or M 2. The home-visit rehabilitation user has been continuously using home-visit rehabilitation for 6 months or longer.
Classification by specialty
| Geriatrics | Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify the reasons why family caregivers wish to continue home-visit rehabilitation even when it does not lead to the maintenance and recovery of physical and mental functions and independence in daily life, based on medical records and interviews. This will allow us to examine family caregivers' perceptions of home-visit rehabilitation and generate new hypotheses about the value of providing home-visit rehabilitation.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
I. Quantitative evaluation conducted during the period of implementation of in-home rehabilitation 1 Basic information In-home rehabilitation user: age, gender, disease name/type, level of care required, level of independence in daily living, etc. Family caregivers: age, gender, relationship with the person requiring care, number of persons living together, period of care, etc.
2 Status of in-home rehabilitation Number of times used (times/week), period since in-home rehabilitation started
3 Family caregiver assessment Burden of caregiver: Multidimensional Burden of Caregiver Scale (Burden Index of Caregiver) Subjective sense of proficiency in caregiving: Caregiver mastery assessment Social care-related QOL: Adult Social Care Outcomes Toolkit for carers Items 1, 2 and 3 To collect items 1, 2, and 3 retrospectively from the medical information of home-visit rehabilitation.
Key secondary outcomes
Base
Study type
Others,meta-analysis etc
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
The target is 1 to 5 family caregivers who were mainly responsible for caring for home-visit rehabilitation users who meet the following conditions. 1. The home-visit rehabilitation user's bedridden level is B1/B2 or C1/C2 1. The home-visit rehabilitation user's level of independence in daily living for the elderly with dementia is III, IV or M 2. The home-visit rehabilitation user has continuously used home-visit rehabilitation for 6 months or longer.
Key exclusion criteria
1 If the applicant is unable to respond to the interview due to health, cognitive function, or mental health issues 2 If the applicant does not consent to participate in this study
Target sample size
5
Research contact person
Name of lead principal investigator
| 1st name | Tomohisa |
| Middle name | |
| Last name | Chibana |
Organization
Kawaguchi Neurosurgical Rehabilitation Clinic
Division name
Department of Rehabilitation
Zip code
5730086
Address
9-25-202 Koroen-cho, Hirakata-shi, Osaka-fu
TEL
0728351010
kawaguchi.ns.reha@gmail.com
Public contact
Name of contact person
| 1st name | Shinya |
| Middle name | |
| Last name | Iki |
Organization
Kawaguchi Neurosurgical Rehabilitation Clinic
Division name
Department of Rehabilitation
Zip code
5730086
Address
9-25-202 Koroen-cho, Hirakata-shi, Osaka-fu
TEL
0728351010
Homepage URL
kawaguchi.ns.reha@gmail.com
Sponsor or person
Institute
Kawaguchi Neurosurgical Rehabilitation Clinic
Institute
Department
Personal name
Funding Source
Organization
Kawaguchi Neurosurgical Rehabilitation Clinic
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 Neurosurgical Rehabilitation Clini
Address
9-25-202 Koroen-cho, Hirakata-shi, Osaka-fu
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
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 10 | Month | 03 | 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
| 2024 | Year | 10 | Month | 03 | Day |
Date of IRB
| 2024 | Year | 10 | Month | 02 | Day |
Anticipated trial start date
| 2024 | Year | 10 | Month | 03 | Day |
Last follow-up date
| 2026 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
The significance and purpose of the study will be explained orally to the potential research subjects. After obtaining consent, the purpose and significance of the research will be explained orally and in writing (separate documents: Research Explanation to Subjects and Withdrawal of Consent Form) to the potential research subjects, and they will be designated as research participants upon submission of the consent form. Interviews will be conducted for 15 to 30 minutes per person, and will be face-to-face interviews. Interviews will be conducted in an environment where privacy can be maintained. Interviews will be conducted in a privacy-preserving environment. The interviews will be recorded using an IC recorder after obtaining consent from the research participants. The interview will be conducted by the principal investigator after practicing the interview several times with the research subjects. After the interviews, a verbatim transcript will be made from the audio recordings, and qualitative data analysis will be conducted.
Management information
Registered date
| 2024 | Year | 10 | Month | 03 | Day |
Last modified on
| 2024 | Year | 10 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000063685
