UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000037966 |
|---|---|
| Receipt number | R000043256 |
| Scientific Title | Effects of visit assessment by rehabilitation professionals on independence of community-dwelling older adults with mild disability: a randomized controlled trial |
| Date of disclosure of the study information | 2019/09/09 |
| Last modified on | 2023/03/13 11:45:50 |
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Basic information
Public title
Research for community-based services for preventive long-term care by promoting social participation_Evaluation of effectiveness of visit assessment by rehabilitation professionals
Acronym
Evaluation of effectiveness of visit assessment by rehabilitation professionals
Scientific Title
Effects of visit assessment by rehabilitation professionals on independence of community-dwelling older adults with mild disability: a randomized controlled trial
Scientific Title:Acronym
Effects of visit assessment by rehabilitation professionals on independence of community-dwelling older adults with mild disability
Region
| Japan |
Condition
Condition
The subject of Community Support Projects of municipalities
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Compared to those who did not receive the "Visit assessment by rehabilitation professionals" for those who wish to receive the subject of visiting and commuting care services in Community Support Projects of the Hofu City The randomized controlled trial will examine whether the rate of unused visiting and commuting care services at the 12th week after the date (consent date) is excellent.
In addition, we will also analyze the effects (including physical function improvement effects, social participation and activity improvement effects) of the subject by "Visit assessment by rehabilitation professionals" at the same time.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
No use of home-visit and/or commuting services at 12 weeks after the enrollment
Key secondary outcomes
All secondary outcomes will be assessed at 12 weeks after the enrollment.
-Subjective well-being
-Instrumental Activity of Daily Living assessed by the Tokyo Metropolitan Institute of Gerontology Index of Competence (TMIG-Index of Competence)
-Quality of Life assessed by the Japanese version of the EQ-5D-5L
-Depressive symptom assessed by the Geriatric Depression Scale
-Physical Activity of Elderly assessed by the Physical Activity Scale for the Elderly (PASE) in Japanese elderly people
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
YES
Dynamic allocation
YES
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Behavior,custom |
Interventions/Control_1
An enhanced home-visit comprehensive assessment will be conducted by a rehabilitation specialist plus a staff in the Community General Support Center. The rehabilitation specialist will give advices to the participants and the staff according to the needs and problems on the participant. Advices will include physical function improvement, environmental improvement, ingenuity of daily activities, use of local resources, use of long-term care services, and so on.
Interventions/Control_2
A usual home-visit assessment will be conducted by a staff in the Community General Support Center.
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
| 65 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
-Certified as the Community Support Projects of municipalities
-Have an intention to use any home-visit and/or commuting long-term care services for the frail elderly
Key exclusion criteria
-Those who cannot walk alone using walker and cane
-Those who cannot eat alone
-Those who cannot excrete alone in the toilet
-Those who have forgotten things and have difficulty in daily life
Target sample size
330
Research contact person
Name of lead principal investigator
| 1st name | Shinji |
| Middle name | |
| Last name | Hattori |
Organization
Association for Health Economics Research and Social Insurance and Welfare
Division name
Institute for Health Economics and Policy
Zip code
105-0001
Address
3F,Tokyu Toranomon Bldg,1-21-19,Toranomon, Minato-ku, Tokyo,105-0003 Japan
TEL
03-3593-8918
shinji.hattori@ihep.jp
Public contact
Name of contact person
| 1st name | Shinji |
| Middle name | |
| Last name | Hattori |
Organization
Association for Health Economics Research and Social Insurance and Welfare
Division name
Institute for Health Economics and Policy
Zip code
105-0001
Address
3F,Tokyu Toranomon Bldg,1-21-19,Toranomon, Minato-ku, Tokyo,105-0003 Japan
TEL
03-3593-8918
Homepage URL
shinji.hattori@ihep.jp
Sponsor or person
Institute
Association for Health Economics Research and Social Insurance and Welfare
Institute
Department
Personal name
Funding Source
Organization
Association for Health Economics Research and Social Insurance and Welfare
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Hofu City,Yamaguchi
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Association for Health Economics Research and Social Insurance and Welfare
Address
3F,Tokyu Toranomon Bldg,1-21-19,Toranomon, Minato-ku, Tokyo,105-0003 Japan
Tel
03-3593-8918
shirasu@ihep.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
山口県防府市
Other administrative information
Date of disclosure of the study information
| 2019 | Year | 09 | Month | 09 | 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
No longer recruiting
Date of protocol fixation
| 2019 | Year | 09 | Month | 06 | Day |
Date of IRB
| 2019 | Year | 07 | Month | 22 | Day |
Anticipated trial start date
| 2019 | Year | 09 | Month | 09 | Day |
Last follow-up date
| 2020 | Year | 12 | Month | 28 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2019 | Year | 09 | Month | 08 | Day |
Last modified on
| 2023 | Year | 03 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043256
| Research Plan | |
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| 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 |
