UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000059505 |
|---|---|
| Receipt number | R000068063 |
| Scientific Title | A cross-sectional study on the relationship between care level and activities of daily living (ADL), and user satisfaction and caregiver burden measured by the Zarit Burden Interview among day-care rehabilitation users |
| Date of disclosure of the study information | 2025/10/22 |
| Last modified on | 2025/10/22 19:02:43 |
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Basic information
Public title
A cross-sectional study on the relationship between care level, activities of daily living (ADL), user satisfaction, and caregiver burden among day-care rehabilitation users at our facility
Acronym
Relationship between care level, ADL, satisfaction, and caregiver burden in day-care rehabilitation users
Scientific Title
A cross-sectional study on the relationship between care level and activities of daily living (ADL), and user satisfaction and caregiver burden measured by the Zarit Burden Interview among day-care rehabilitation users
Scientific Title:Acronym
Relationship between care level, ADL, satisfaction, and caregiver burden in day-care rehabilitation users
Region
| Japan |
Condition
Condition
cerebrovascular diseases, orthopedic disorders
Classification by specialty
| Orthopedics | Neurosurgery | Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Day-care rehabilitation plays an important role in helping individuals maintain and improve independent living in their familiar communities. In particular, short-duration day-care rehabilitation has gained attention for its ability to reduce physical burden on users and support the balance between rehabilitation and home life. However, few university hospitals currently offer short-duration day-care rehabilitation services, and research on their effectiveness remains limited.
In this context, improving service quality requires not only the perspectives of medical and care professionals, but also a precise understanding of the satisfaction and needs of users and their families. Therefore, this study aims to clarify user satisfaction and caregiver burden through questionnaire-based assessments conducted in the short-duration day-care rehabilitation program provided at our institution. By examining regular assessments alongside subjective evaluations, we seek to contribute to the provision of higher-quality services.
The findings of this study are expected to support the dissemination and development of short-duration day-care rehabilitation in the community and promote improvements in service quality.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
This study will conduct a questionnaire survey on user satisfaction and caregiver burden among patients attending day-care rehabilitation services at our institution and their families. The survey will assess satisfaction levels and caregiver burden using the zarit Burden Interview.
Information on ADL and treatment content will be obtained from inpatient medical records and rehabilitation implementation records, extracted via the electronic medical record system and the rehabilitation department's clinical database.
Approximately 100 participants are expected based on past medical records. Responses will be collected via paper or web-based forms, with an estimated completion time of 10 minutes per questionnaire.
Key secondary outcomes
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Individuals who have received a full written explanation of the study, understood its content, and voluntarily provided written informed consent.
Users of the day-care rehabilitation services at Fujita Health University Hospital and their family members.
Individuals aged 20 years or older at the time of consent.
No restriction on gender.
Key exclusion criteria
Individuals deemed inappropriate for inclusion by the principal investigator or co-investigators
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Daisuke |
| Middle name | |
| Last name | Matura |
Organization
Fujita Health University Hospital
Division name
Department of Rehabilitation Medicine, S
Zip code
470-1192
Address
1-98 Dengakugakubo, Kutsukake-cho, Toyoake-shi, Aichi 470-1192, Japan
TEL
0562-93-9715
chiyuri@fujita-hu.ac.jp
Public contact
Name of contact person
| 1st name | Chiyuri |
| Middle name | |
| Last name | Takami |
Organization
Fujita Health University Hospital
Division name
Department of Rehabilitation
Zip code
470-1192
Address
1-98 Dengakugakubo, Kutsukake-cho, Toyoake-shi, Aichi 470-1192, Japan
TEL
0562-93-9715
Homepage URL
chiyuri@fujita-hu.ac.jp
Sponsor or person
Institute
Fujita Health University Hospital
Institute
Department
Personal name
Funding Source
Organization
Fujita Health University Hospital
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Fujita Health University Hospital
Address
1-98 Dengakugakubo, Kutsukake-cho, Toyoake-shi, Aichi 470-1192, Japan
Tel
0562-93-2865
f-irb@fujita-hu.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
| 2025 | Year | 10 | Month | 22 | 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
| 2025 | Year | 04 | Month | 04 | Day |
Date of IRB
Anticipated trial start date
| 2025 | Year | 12 | Month | 01 | Day |
Last follow-up date
| 2026 | Year | 12 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This study is a cross-sectional observational research conducted at Fujita Health University Hospital, targeting users of outpatient rehabilitation services and their family members. Participants will complete questionnaires assessing satisfaction and caregiver burden, which will be analyzed in relation to Activities of Daily Living (ADL) scores and medical record data. Approximately 100 participants are expected for the initial survey, with annual follow-up surveys planned. Personal data will be anonymized, and only aggregated results will be published for academic purposes. Although the study is conducted as part of routine clinical care, written informed consent will be obtained for the use of data in research.
Management information
Registered date
| 2025 | Year | 10 | Month | 22 | Day |
Last modified on
| 2025 | Year | 10 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000068063
