UMIN-CTR Clinical Trial

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