UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000034846 |
|---|---|
| Receipt number | R000039735 |
| Scientific Title | Intervention trial for prevention by multidiscipline risk management to multiple risk events among people living in geriatric health service facilities |
| Date of disclosure of the study information | 2018/11/10 |
| Last modified on | 2018/11/10 09:10:42 |
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Basic information
Public title
Intervention trial for prevention by multidiscipline risk management to multiple risk events among people living in geriatric health service facilities
Acronym
Risk events prevention in GHSF
Scientific Title
Intervention trial for prevention by multidiscipline risk management to multiple risk events among people living in geriatric health service facilities
Scientific Title:Acronym
Risk events prevention in GHSF
Region
| Japan |
Condition
Condition
falls, aspiration pneumonia, pressure ulcers, dehydration, and fever
Classification by specialty
| Geriatrics | Nursing |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Effect on risk event reduction such as fall, aspiration pneumonia, pressure ulcers, dehydration, and fever by Multidisciplinary Risk management
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Assessment
Primary outcomes
Frequency or risk events
Reduction of risk events
Events such as falls, aspiration pneumonia, pressure ulcers, dehydration, and fever
Key secondary outcomes
Number needed to treat to reduce risk events
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Historical
Stratification
YES
Dynamic allocation
NO
Institution consideration
Institution is considered as a block.
Blocking
YES
Concealment
No need to know
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
Risk management based on multidisciplinary care-management
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
| 65 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Selection of the facility
Intervention group: Facility care-worker attended the risk-management lecture and pursuit the risk-management process according to the lecture.
Control group: conventional risk management
Participants
Newly admitted elderly patients to the facilities
Key exclusion criteria
When the person or proxy family did not provide written informed consent
Target sample size
6000
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Jiro Okochi |
Organization
Association of Japanese Geriatric service facilities
Division name
Permanent director
Zip code
Address
Kokuryu Shibakouen building6F 2-6-15 Shibakouen Minato-ku, Tokyo 105-0011
TEL
03-3432-4165
Jirookochi1222@gmail.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Tomomi Takano |
Organization
Association of Japanese Geriatric service facilities
Division name
No1 Division
Zip code
Address
Kokuryu Shibakouen building6F, 2-6-15 Shibakouen Minato-ku, Tokyo 105-0011
TEL
03-3432-4165
Homepage URL
http://www.roken.or.jp/wp/wp-content/uploads/2012/07/H26_kinouteika_report.pdf
takanota@roken.or.jp
Sponsor or person
Institute
Ministry of Health, Labour and Welfare
Institute
Department
Personal name
Funding Source
Organization
Ministry of health, labor and welfare
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Department of Healthcare Quality Assessment, The University of Tokyo,
Department of Health Policy and Management, School of Medicine, Keio University
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
Secondary IDs
Secondary IDs
YES
Study ID_1
23
Org. issuing International ID_1
Association of Japanese Geriatric service facilities
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 11 | Month | 10 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
http://www.roken.or.jp/wp/wp-content/uploads/2012/07/H26_kinouteika_report.pdf
Number of participants that the trial has enrolled
Results
1. Facilities with risk managers scored better than facilities without risk manager in all of the following including fully implementing R4 system (odds ratio=with risk manager 1.50, without risk manager 0.10), using the risk manual booklet published by Zenroken (odds ratio=2.26 with risk manager, 0.53 without risk manager), and implementing risk management measures at the time of care planning (odds ratio=0.85 with RM, 0.53 without risk manager).
2. Facilities following standard risk management processes (intervention group) scored better than facilities not following standard risk management processes in all of the following including fully implementing R4 system (odds ratio=intervention 2.52, non-intervention 0.08), using Risk manual booklet (odds rate = intervention 1.48, non-intervention 0.74). In short, facilities with risk manager(s), and facilities following risk management processes are providing better quality of service in terms of risk management for elderly people.
3. However we could not observe reductions in personal outcomes such as number of falls, aspiration pneumonia or pressure ulcers as a result of intervention in this study.
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
Completed
Date of protocol fixation
| 2014 | Year | 08 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 08 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2018 | Year | 11 | Month | 10 | Day |
Last modified on
| 2018 | Year | 11 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039735
