UMIN-CTR Clinical Trial

Basic information
Public title	Survey of Rehabilitation System for Dysphagia by Long-Term Care Insurance System
Acronym	Survey of Rehabilitation System for Dysphagia by Long-Term Care Insurance System
Scientific Title	Survey of Rehabilitation System for Dysphagia by Long-Term Care Insurance System
Scientific Title:Acronym	Survey of Rehabilitation System for Dysphagia by Long-Term Care Insurance System
Region	Japan

Condition
Condition	Dysphagia
Classification by specialty	Rehabilitation medicine
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The purpose of this study was to understand the state of implementation and acceptance of eating and swallowing rehabilitation provided by the nursing care insurance system, and to examine the problems in constructing a seamless eating and swallowing rehabilitation system.
Basic objectives2	Others
Basic objectives -Others	Based on the results of this study, the development of a rehabilitation system tool using ICT is expected to realize continuous eating and swallowing rehabilitation, contributing to the prevention of complications and the realization of a healthy longevity society.
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Rate of rehabilitation for dysphagia
Key secondary outcomes

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	20 years-old <=
Age-upper limit	100 years-old >=
Gender	Male and Female
Key inclusion criteria	Person in charge of day-care rehabilitation facilities and home-visit rehabilitation facilities in charge of the Community General Support Center
Key exclusion criteria	Cases for which cooperation in the investigation was not obtained
Target sample size	120

Research contact person
Name of lead principal investigator	1st name Takako Middle name Last name Nagai
Organization	Nihon University Hospital
Division name	Rehabilitation medicine
Zip code	1018309
Address	Chiyoda-ku Kanda Surugadai 1-6
TEL	0332931711
Email	ntnyf092@yahoo.co.jp

Public contact
Name of contact person	1st name Takako Middle name Nagai Last name Nagai
Organization	Nihon University Hospital
Division name	Rehabilitation medicine
Zip code	173-8610
Address	1-6 Kandasurugadai, Chiyoda-ku,, Tokyo,Japan
TEL	0339728111
Homepage URL
Email	ntnyf092@yahoo.co.jp

Sponsor
Institute	Nihon University Schoool of Medicime
Institute
Department

Funding Source
Organization	KAKENHI
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	Nihon University hospital
Address	1-6 Kandasurugadai, Chiyoda-ku,, Tokyo,Japan
Tel	0332931711
Email	ntnyf092@yahoo.co.jp

Secondary IDs
Secondary IDs	YES
Study ID_1	21K11250
Org. issuing International ID_1	KAKENHI
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information	2021 Year 12 Month 02 Day

Related information
URL releasing protocol
Publication of results	Published

Result
URL related to results and publications
Number of participants that the trial has enrolled	56
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	2021 Year 06 Month 10 Day
Date of IRB	2021 Year 06 Month 10 Day
Anticipated trial start date	2021 Year 08 Month 01 Day
Last follow-up date	2021 Year 08 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	Completion of questionnaire survey collection

Management information
Registered date	2021 Year 12 Month 02 Day
Last modified on	2022 Year 06 Month 06 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000052786