UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000027478
Receipt number R000031478
Scientific Title Study on the effect of oral health related educational program among caregivers in nursing home
Date of disclosure of the study information 2017/06/02
Last modified on 2017/11/23 12:49:45

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Basic information

Public title

Study on the effect of oral health related educational program among caregivers in nursing home

Acronym

Study on the effect of oral health related educational program among caregivers

Scientific Title

Study on the effect of oral health related educational program among caregivers in nursing home

Scientific Title:Acronym

Study on the effect of oral health related educational program among caregivers

Region

Japan


Condition

Condition

None

Classification by specialty

Dental medicine Nursing

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

The purpose of this study are to influence of oral health related educational program on caregiver burden.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

original questionnaire

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

No treatment

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

2

Purpose of intervention

Educational,Counseling,Training

Type of intervention

Other

Interventions/Control_1

Oral health related educational program (High self-efficacy)

Interventions/Control_2

Oral health related educational program (Low self-efficacy)

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

120 years-old >

Gender

Male and Female

Key inclusion criteria

caregiver

Key exclusion criteria

dental staff

Target sample size

100


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Yuhei Matsuda

Organization

Kyushu Dental University

Division name

Oral health sciences

Zip code


Address

2-6-1, Manazuru, Kokura-kita, Kitakyushu, Fukuoka

TEL

0932853109

Email

r15matsuda@fa.kyu-dent.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Yuhei Matsuda

Organization

Kyushu Dental University

Division name

Oral health sciences

Zip code


Address

2-6-1, Manazuru, Kokura-kita, Kitakyushu, Fukuoka

TEL

0932853109

Homepage URL


Email

r15matsuda@fa.kyu-dent.ac.jp


Sponsor or person

Institute

Kyushu Dental University

Institute

Department

Personal name



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


Address


Tel


Email



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 06 Month 02 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

Completed

Date of protocol fixation

2017 Year 06 Month 01 Day

Date of IRB


Anticipated trial start date

2017 Year 06 Month 02 Day

Last follow-up date

2017 Year 11 Month 01 Day

Date of closure to data entry

2017 Year 11 Month 23 Day

Date trial data considered complete

2017 Year 11 Month 23 Day

Date analysis concluded

2017 Year 11 Month 27 Day


Other

Other related information



Management information

Registered date

2017 Year 05 Month 24 Day

Last modified on

2017 Year 11 Month 23 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031478


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name