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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000025785
Receipt No. 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 2019/07/25

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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
Email 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
Email ywata@tmig.or.jp

Sponsor
Institute Research on Social and Human Sciences Tokyo Metropolitan Institute of Gerontology
Institute
Department

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
Email 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 No longer recruiting
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
2019 Year 07 Month 25 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029657

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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