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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000037415
Receipt No. R000042654
Scientific Title The before-after study to evaluate effects of the dialogue system to dementia patient with hearing loss.
Date of disclosure of the study information 2019/07/22
Last modified on 2019/07/18

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Basic information
Public title The clarification of influence that dialogue through support system give for clinical symptoms of dementia patient with hearing loss.
Acronym The clarification of influence that dialogue using a machine supporting give for clinical symptoms of dementia patient with hearing loss.
Scientific Title The before-after study to evaluate effects of the dialogue system to dementia patient with hearing loss.
Scientific Title:Acronym HDC study
Region
Japan

Condition
Condition dementia
Classification by specialty
Psychiatry Nursing
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 A purpose of this study is to make clear that the dialogue through the support system show an effect for
psychiatric symptoms of dementia patients with hearing loss.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes The Japanese version of Neuropsychiatric Inventory-Nursing Home Version.
I evaluate it three months after an investigation start.
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Device,equipment
Interventions/Control_1 When nurses dialogue with patients, nurses do it anytime using dialogue support system, comumoon (universal sound design Co., Ltd.).
Intervention period is three months.
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 1. dementia patients with the hearing loss
1) Patients who is admitted to the hospital.
2) Patients who had a diagnosis of dementia by
DSM-5.
3) Patients that a hearing loss was clarifi-
ed in audiometry.
4) Patients that an agreement of study entry
was provided from the person and family.
5) The sex does not matter.
2. nurse
1) Nurses who nurse dementia patients with
the hearing loss
2) Nurses that an agreement of study entry
was provided from the person.
3) The sex does not matter.
Key exclusion criteria 1. dementia patients with the hearing loss
1) Patients that an agreement was not
provided for a study from the person and
family.
2) Patients have already used a hearing aid.
3) Patients that a hearing loss was not
clarified in audiometry.
2. Nueses
1) Nurses that an agreement was not
provided for a study from the person.
Target sample size 54

Research contact person
Name of lead principal investigator
1st name Shinichi
Middle name
Last name Chiba
Organization Tokushima University Graduate School
Division name Institute of Biomedical Sciences
Zip code 7708503
Address 3-18-5 Kuramoto-cho, Tokushima
TEL 0886337614
Email chiba.shinichi@tokushima-u.ac.jp

Public contact
Name of contact person
1st name Shinichi
Middle name
Last name Chiba
Organization Tokushima University Graduate School
Division name Institute of Biomedical Sciences
Zip code 7708503
Address 3-18-5 Kuramoto-cho, Tokushima
TEL 0886337614
Homepage URL
Email chiba.shinichi@tokushima-u.ac.jp

Sponsor
Institute Institute of Biomedical Sciences, Tokushima University Graduate School
Institute
Department

Funding Source
Organization Institute of Biomedical Sciences, Tokushima University Graduate School
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 The Research Ethical Committee, University of Tokushima Hospital
Address 2-50-1 Kuramoto-cho, Tokushima
Tel 0886339294
Email awachiken@tokushima-u.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
2019 Year 07 Month 22 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 Preinitiation
Date of protocol fixation
2019 Year 07 Month 11 Day
Date of IRB
Anticipated trial start date
2019 Year 07 Month 22 Day
Last follow-up date
2023 Year 08 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2019 Year 07 Month 18 Day
Last modified on
2019 Year 07 Month 18 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042654

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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