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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000041370
Receipt No. 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

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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
Email 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
Email kawaguchi.ns.reha@gmail.com

Sponsor
Institute Kawaguchi Neurosurgery Rehabilitation Clinic
Institute
Department

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
Email 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047232

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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