UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000046258
Receipt number R000052786
Scientific Title Survey of Rehabilitation System for Dysphagia by Long-Term Care Insurance System
Date of disclosure of the study information 2021/12/02
Last modified on 2022/06/06 12:03:30

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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 or person

Institute

Nihon University Schoool of Medicime

Institute

Department

Personal name



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

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052786


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name