UMIN-CTR Clinical Trial

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