UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000045771 |
|---|---|
| Receipt number | R000052255 |
| Scientific Title | Effect of group rehabilitation on quality of life for people requiring nursing care |
| Date of disclosure of the study information | 2021/10/16 |
| Last modified on | 2021/10/16 16:56:52 |
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Basic information
Public title
Effect of group rehabilitation on quality of life for people requiring nursing care
Acronym
Effect of group rehabilitation on quality of life for people requiring nursing care
Scientific Title
Effect of group rehabilitation on quality of life for people requiring nursing care
Scientific Title:Acronym
Effect of group rehabilitation on quality of life for people requiring nursing care
Region
| Japan |
Condition
Condition
The general public
Classification by specialty
| Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to clarify the effects of group rehabilitation on the quality of life of day-care center users by providing interventions that take into account the characteristics of the users, such as their orientation toward social comparison and their emotions, which are advantages of group rehabilitation.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Collection of basic information
Assessment of nave function
Activities of daily living and practical activities of daily living
Degree of social interaction with humans
Quality of life Peel off the cover
Orientation to social comparison)
Emotions associated with social comparison
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
Users who are in daycare and require nursing care and are able to walk independently or under supervision.
Those who are able to complete the questionnaire.
Users who can continue to use the service for at least three months.
If you have any questions, please contact us. Users who can understand and sign a written consent form.
Key exclusion criteria
Patients for whom it is difficult to conduct the assessment of walking ability.
Those who have difficulty in answering all the questionnaire assessments.
Those who have difficulty in continuing to use the day-care service for 3 months.
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Atsushi |
| Middle name | |
| Last name | Mikami |
Organization
Corporation Full Life
Rehabilitation Fitness Full Life
Division name
General Nursing Department
Zip code
5720005
Address
1-29, Naruta-cho, Neyagawa-city, Osaka.
TEL
0728138000
kawaguchi.ns.reha@gmail.com
Public contact
Name of contact person
| 1st name | Atsushi |
| Middle name | |
| Last name | Mikami |
Organization
Corporation Full Life Rehabilitation Fitness Full Life
Division name
General Nursing Department
Zip code
5720005
Address
1-29, Naruta-cho, Neyagawa-city, Osaka.
TEL
0728138000
Homepage URL
kawaguchi.ns.reha@gmail.com
Sponsor or person
Institute
Corporation Full Life Rehabilitation Fitness Full Life
Institute
Department
Personal name
Funding Source
Organization
None
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
Kawaguchi Neurosurgery Rehabilitation Clinic
Address
rehabilitation department
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
| 2021 | Year | 10 | 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
Open public recruiting
Date of protocol fixation
| 2021 | Year | 10 | Month | 16 | Day |
Date of IRB
| 2021 | Year | 10 | Month | 15 | Day |
Anticipated trial start date
| 2021 | Year | 10 | Month | 16 | Day |
Last follow-up date
| 2022 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
None
Management information
Registered date
| 2021 | Year | 10 | Month | 16 | Day |
Last modified on
| 2021 | Year | 10 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052255
