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Name
UMIN ID

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000048527
Receipt No. R000055295
Scientific Title Juntendo oral hypofunction registration of exploring for predictors and prognosis in Elderly in Tokyo.
Date of disclosure of the study information 2022/08/01
Last modified on 2022/07/31

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Basic information
Public title Juntendo oral hypofunction registration of exploring for predictors and prognosis in Elderly in Tokyo.
Acronym Juntendo oral hypofunction registration of exploring for predictors and prognosis in Elderly in Tokyo.
Scientific Title Juntendo oral hypofunction registration of exploring for predictors and prognosis in Elderly in Tokyo.
Scientific Title:Acronym Juntendo oral hypofunction registration of exploring for predictors and prognosis in Elderly in Tokyo.
Region
Japan

Condition
Condition Sarcopenia, frailty
Classification by specialty
Medicine in general Gastroenterology Hepato-biliary-pancreatic medicine
Cardiology Pneumology Geriatrics
Dental medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To extend healthy life expectancy by investigating the actual situation of oral frailty, which is one of the causes of falls and decreased mental and social activity level due to low nutrition, and to study countermeasure methods to reduce the risk to nursing care needs.
Basic objectives2 Others
Basic objectives -Others The purpose of this study is to investigate the frequency and predictors of oral hypofunction and frailty and sarcopenia in outpatients aged 65 years and older at our medical center, and to further investigate the prognosis of oral hypofunction and factors that worsen prognosis.
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Incidence of all-cause mortality and hospitalization for treatment at 1 and 2 years after the start of enrollment, respectively, according to the presence of oral hypofunction and frailty/sarcopenia
Key secondary outcomes Incidence of major bleeding, clinically significant non-major bleeding, cardiovascular death, hospitalization for heart failure, nonfatal myocardial infarction, coronary revascularization, peripheral vascular disease, intracranial bleeding, stroke, transient ischemic attack, new onset of cancer, number of falls, fractures, gastrointestinal bleeding, hospitalization for pneumonia, increased dose of dementia medication, depending on presence of oral hypofunction and frailty/sarcopenia

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 1 Regular outpatient at Juntendo Tokyo Koto Medical Center for the Elderly, Juntendo University School of Medicine 2 Age 65 or older
3 Independent walking (including walking with a cane)
4 Patients with consent to participate in the study
Key exclusion criteria 1 Patients who are unable to walk independently or who are unable to take a medical history/questionnaire
2 Patients with serious cerebrovascular, cardiac, respiratory, hepatic, renal, gastrointestinal, or endocrine-metabolic diseases 3 Patients whose life expectancy is judged to be within 1 year due to malignant diseases
4 Patients deemed ineligible by the attending physician
Target sample size 500

Research contact person
Name of lead principal investigator
1st name Kei
Middle name
Last name Matsuno
Organization Juntendo University Graduate School of Medicine
Division name Department of Respiratory Medicine
Zip code 136-0075
Address 3-3-20, Shinsuna, Koto-ku, Tokyo
TEL 03-5632-3111
Email kmatsuno@juntendo.ac.jp

Public contact
Name of contact person
1st name Daisuke
Middle name
Last name Asaoka
Organization Juntendo University Graduate School of Medicine
Division name Department of Gastroenterology
Zip code 136-0075
Address 3-3-20, Shinsuna, Koto-ku, Tokyo
TEL 03-5632-3111
Homepage URL
Email daisuke@juntendo.ac.jp

Sponsor
Institute Juntendo Tokyo Koto Geriatric Medical Center
Institute
Department

Funding Source
Organization none
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Juntendo Tokyo Koto Geriatric Medical Center Ethics Committee
Address 3-3-20 Shinsuna, Koto-ku, Tokyo
Tel 03-5632-3111
Email kmatsuno@juntendo.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

Other administrative information
Date of disclosure of the study information
2022 Year 08 Month 01 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 Open public recruiting
Date of protocol fixation
2021 Year 12 Month 02 Day
Date of IRB
2021 Year 12 Month 22 Day
Anticipated trial start date
2022 Year 02 Month 01 Day
Last follow-up date
2026 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information observational study

Management information
Registered date
2022 Year 07 Month 31 Day
Last modified on
2022 Year 07 Month 31 Day


Link to view the page
URL(English) https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055295

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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