UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000032123 |
|---|---|
| Receipt number | 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 | 2024/01/11 19:16:40 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
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(2016), 6 months, 12 months(2016)
Key secondary outcomes
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, who agreed to participate in this study.
Key exclusion criteria
Not above
Target sample size
120
Research contact person
Name of lead principal investigator
| 1st name | Michiko |
| Middle name | |
| Last name | Moriyama |
Organization
Chronic Care & Family Nursing, Graduate School of Biomedical and Health Sciences, Hiroshima University
Division name
Department of Nursing Science
Zip code
734-8553
Address
1-2-3 Kasumi, Minami-ku, Hiroshima, 734-8553 Japan
TEL
082-255-5367
morimich@hiroshima-u.ac.jp
Public contact
Name of contact person
| 1st name | Kanae |
| Middle name | |
| Last name | Osaki |
Organization
Graduate School of Biomedical & Health Sciences major
Division name
Department of Nursing Science
Zip code
734-8553
Address
1-2-3 Kasumi, Minami-ku, Hiroshima, 734-8553 Japan
TEL
082-255-5367
Homepage URL
kanae-osaki@hiroshima-u.ac.jp
Sponsor or person
Institute
Chronic Care & Family Nursing, Graduate School of Biomedical and Health Sciences
Institute
Department
Personal name
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
Hiroshima University
Address
Kasumi 1-2-3 Minami-ku Hiroshima
Tel
082-257-1576
kasumi-kenkyu@office.hiroshima-u.ac.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
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
101
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
Completed
Date of protocol fixation
| 2016 | Year | 10 | Month | 04 | Day |
Date of IRB
| 2016 | Year | 10 | Month | 04 | Day |
Anticipated trial start date
| 2016 | Year | 10 | Month | 04 | Day |
Last follow-up date
| 2021 | Year | 02 | Month | 28 | Day |
Date of closure to data entry
| 2021 | Year | 02 | Month | 28 | Day |
Date trial data considered complete
| 2021 | Year | 02 | Month | 28 | Day |
Date analysis concluded
| 2021 | Year | 03 | Month | 31 | Day |
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
Management information
Registered date
| 2018 | Year | 04 | Month | 05 | Day |
Last modified on
| 2024 | Year | 01 | Month | 11 | Day |
Link to view the page
Value
https://center6.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 |
