UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000041370 |
|---|---|
| Receipt number | R000047232 |
| Scientific Title | Effect of relationship based on goal setting in day care rehabilitation on quality of life of care recipient |
| Date of disclosure of the study information | 2020/08/10 |
| Last modified on | 2020/08/10 11:37:07 |
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Basic information
Public title
Effect of relationship based on goal setting in day care rehabilitation on quality of life of care recipient
Acronym
Effect of relationship based on goal setting in day care rehabilitation on quality of life of care recipient
Scientific Title
Effect of relationship based on goal setting in day care rehabilitation on quality of life of care recipient
Scientific Title:Acronym
Effect of relationship based on goal setting in day care rehabilitation on quality of life of care recipient
Region
| Japan |
Condition
Condition
day care rehabilitation users
Classification by specialty
| Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to clarify the effect of goal-setting relationships on quality of life for daycare rehabilitation users.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
1.Collection of basic information
Age, gender, name of main disease, name of comorbidity, degree of need for nursing care, frequency of outpatient rehabilitation
2.Evaluation of mental and physical function
Grip strength, walking ability (Timed up & Go test)
3.Daily life activities/applied daily life activities
Interest Check Sheet, French Activities Index (F A I)
4.Degree of socializing
Japanese version Lubben Social Network Scale (L S N S-6)
5.Quality of life
Revised PGC Morale Scale (The Philadelphia Geriatric Center Morale Scale)
6.Goal setting
Goal Attainment Scaling (Goal Attainment Scaling)
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
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
Tsusho rehabilitation users
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
day care rehabilitation users
Key exclusion criteria
1.Users who have significant walking disorders and are at high risk of falls even under the supervision of a therapist.
(Wheelchair users, users who need assistance walking, and other therapists judge that the risk of falls is high.
Users)
2.Users who have difficulty understanding the language instruction due to cognitive decline or higher brain dysfunction, and who have difficulty answering the questionnaire.
3.Users who have difficulty continuing to use day care rehabilitation for 3 months
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Atsushi |
| Middle name | |
| Last name | Mikami |
Organization
Kawaguchi Neurosurgery Rehabilitation Clinic
Division name
Department of Rehabilitation
Zip code
5730086
Address
9-25-202 Koriencho, Hirakata City, Osaka
TEL
0728351010
kawaguchi.ns.reha@gmail.com
Public contact
Name of contact person
| 1st name | Shinya |
| Middle name | |
| Last name | Iki |
Organization
Kawaguchi Neurosurgery Rehabilitation Clinic
Division name
Department of Rehabilitation
Zip code
5730086
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
Daido Life Welffare Foundation
Organization
Division
Category of Funding Organization
Non profit foundation
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）、石巻健育会病院（宮城県）、熱川温泉病院（静岡県）、もりおか往診ホームケアクリニック（岩手県）
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 | 05 | Month | 31 | 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=R000047232
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
