UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000025785 |
|---|---|
| Receipt number | R000029657 |
| Scientific Title | Randomized controlled trial on the effect of continuation of home care by support on nutrition and oral health care after discharge from Long-Term Care Health Facilities |
| Date of disclosure of the study information | 2017/01/23 |
| Last modified on | 2020/02/26 16:08:54 |
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Basic information
Public title
Randomized controlled trial on the effect of continuation of home care by support on nutrition and oral health care after discharge from Long-Term Care Health Facilities
Acronym
The effect of continuation of home care by support on nutrition and oral health care
Scientific Title
Randomized controlled trial on the effect of continuation of home care by support on nutrition and oral health care after discharge from Long-Term Care Health Facilities
Scientific Title:Acronym
The effect of continuation of home care by support on nutrition and oral health care
Region
| Japan |
Condition
Condition
Pneumonia,Malnutrition,Infection
Classification by specialty
| Geriatrics | Dental medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify the effect of assessment and support for nutrition and oral health care by professionals on continued home care to the elderly after discharge from Long-Term Care Health Facilities
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
The duration of home care after discharge from Long-Term Care Health Facilities
Key secondary outcomes
Nutritional status
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Other |
Interventions/Control_1
The assessment and support for nutrition and oral health care by professionals to the elderly after discharge from Long-Term Care Health Facilities
Interventions/Control_2
Observation only
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
Elderly people discharged from cooperating Long-Term Care Health Facilities to home
Key exclusion criteria
Elderly people discharged from cooperating Long-Term Care Health Facilities to another care facility.
Non oral intake person, Severe dementia, With poor control chronic disease, Participant or their families desiring to enter the care facility.
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Yutaka |
| Middle name | |
| Last name | Watanabe |
Organization
Tokyo Metropolitan Institute of Gerontology
Division name
Research on Social and Human Sciences
Zip code
1730015
Address
35-2 Sakaecho Itabashi-ku Tokyo 173-0015, Japan
TEL
03-3964-114
ywata@tmig.or.jp
Public contact
Name of contact person
| 1st name | Yutaka |
| Middle name | |
| Last name | Watanabe |
Organization
Tokyo Metropolitan Institute of Gerontology
Division name
Research on Social and Human Sciences
Zip code
1730015
Address
35-2 Sakaecho Itabashi-ku Tokyo 173-0015, Japan
TEL
03-3964-114
Homepage URL
ywata@tmig.or.jp
Sponsor or person
Institute
Research on Social and Human Sciences Tokyo Metropolitan Institute of Gerontology
Institute
Department
Personal name
Funding Source
Organization
Ministry of Health, Labour and Welfare Grant-in-Aid for Scientific Research
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Tokyo Metropolitan Institute of Gerontology
Address
35-2 Sakaecho Itabashi-ku Tokyo 173-0015, Japan
Tel
03-3964-1141
mami_yoshioka@tmghig.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
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 01 | Month | 23 | 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
30
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 | 12 | Month | 10 | Day |
Date of IRB
| 2016 | Year | 12 | Month | 10 | Day |
Anticipated trial start date
| 2017 | Year | 01 | Month | 23 | Day |
Last follow-up date
| 2020 | Year | 03 | 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
| 2017 | Year | 01 | Month | 21 | Day |
Last modified on
| 2020 | Year | 02 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029657
