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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000032123
Receipt No. R000036614
Scientific Title The feasibility of an algorithm utilization for anti-flare measures of frail elderly
Date of disclosure of the study information 2018/04/06
Last modified on 2018/04/05

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Basic information
Public title The feasibility of an algorithm utilization for anti-flare measures of frail elderly
Acronym Frail elderly service matching project
Scientific Title The feasibility of an algorithm utilization for anti-flare measures of frail elderly
Scientific Title:Acronym Frail elderly service matching project
Region
Japan

Condition
Condition Frailty
Classification by specialty
Nursing Not applicable Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The main objective is to prevent high risk elderly in requiring nursing and long-term care supports, and verify the effect by comparing pre and post the intervention. The pilot study also evaluated the practical feasibility of the project and used the adequacy of the algorithm as a secondary objective.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase

Assessment
Primary outcomes 1.Types of services and usage frequency linked by intervention supports
2.Additional support, the types of existing and newly connected services and frequency of usage
3.Homebound score
4.Comprehensive Geriatric Assessment, Locomotive score
5.Psychological indicators: EuroQol-5D-5L score, Subjective sense of well-being
6.Physical indicators: alcohol intake (amount and frequency), presence of falls and fractures, exacerbation of existing diseases (angina pectoris, myocardial infarction, stroke, dialysis introduction etc.), Onset of other diseases, Presence or absence of hospitalization/ reason/ emergency hospitalization or expected hospitalization/ frequency, facility entry, death, transference etc.
7.Presence or absence of nursing-care requirement/ Required degree of care/ Content of service use
8.Hospitalization (reason, number of times, period), facility entry/ transfer, death

Evaluation period: baseline, 3 months, 6 months, 12 months per year
Key secondary outcomes Medical cost / long-term care expenses
Evaluation period: after 12 months and 24 months

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
65 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Those who participated in the project of connecting services to stay healthy, age over 65 years old; live in Kure City, Hiroshima prefecture; responded to the Kihon Checklist, corresponded to three or more items of physical strength, homeboundness, and depression state.
Key exclusion criteria Not above
Target sample size 120

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Michiko Moriyama
Organization Chronic Care & Family Nursing, Graduate School of Biomedical & Health Sciences, Hiroshima University
Division name Department of Nursing Science
Zip code
Address 1-2-3 Kasumi, Minami-ku, Hiroshima, 734-8553 Japan
TEL 082-255-5367
Email morimich@hiroshima-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Kanae Osaki
Organization Graduate School of Biomedical & Health Sciences major
Division name Department of Nursing Science
Zip code
Address 1-2-3 Kasumi, Minami-ku, Hiroshima, 734-8553 Japan
TEL 082-255-5367
Homepage URL
Email kanae-osaki@hiroshima-u.ac.jp

Sponsor
Institute Chronic Care & Family Nursing, Graduate School of Biomedical & Health Sciences
Institute
Department

Funding Source
Organization Kure-city local government
Organization
Division
Category of Funding Organization Local Government
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor HOWCOM Co., Ltd.
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

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 広島県呉市/Kure-city local government

Other administrative information
Date of disclosure of the study information
2018 Year 04 Month 06 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
2016 Year 10 Month 04 Day
Date of IRB
Anticipated trial start date
2016 Year 10 Month 04 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Observation items:

1.Types of services and usage frequency linked by intervention supports
2.Psychological indicators
3.Physical indicators
4.Presence or absence of nursing-care requirement/ Required degree of care/ Content of service use
5.Medical cost / long-term care expenses

Management information
Registered date
2018 Year 04 Month 05 Day
Last modified on
2018 Year 04 Month 05 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036614

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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