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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000006542
Receipt No. R000007753
Scientific Title The care system for Alzheimer's patient to supervise administration with bidirectional IT communications
Date of disclosure of the study information 2011/11/01
Last modified on 2011/10/14

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Basic information
Public title The care system for Alzheimer's patient to supervise administration with bidirectional IT communications
Acronym The care system for Alzheimer's patient to supervise administration with IT
Scientific Title The care system for Alzheimer's patient to supervise administration with bidirectional IT communications
Scientific Title:Acronym The care system for Alzheimer's patient to supervise administration with IT
Region
Japan

Condition
Condition Alzheimer's dementia
Classification by specialty
Neurology Nursing
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The present study is undertaken to analyze the effects of the bidirectional IT communications between Alzheimer's patient and medical staff on supervised administration at home.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Mini Mental State Examination (MMSE), HDS-R, Zarit nursing-care burden scale, Philadelphia Geriatric Center (PGC) moral scale, Lawton instrumental activity of daily living scale (IADL scale), Hiratsuka compliance scale, Daily self administrational table for side effects, The evaluation form of IT's results for Alzheimer's patients, The questionnaire survey to the TV telephone, The questionnaire survey to lifestyle habit
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit
Blinding Open -no one is blinded
Control Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Behavior,custom
Interventions/Control_1 For a period of 3 months, a nurse intervene in a dementia patient and his caregiver through the videophone for 10 minutes once a week. Intercommunication content are compliance check of adhesive skin patch, monitoring for side effects, and so on visually.
Interventions/Control_2 Dementia patients carry on being treated as an outpaint only and they answer the recognition test.
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
100 years-old >
Gender Male and Female
Key inclusion criteria Dementia patients are informed of the nature and purpose of the study before giving their voluntary consent to participate in the study. We select a subject who has TV terephone communication system at his home as an intervention group. Age-, HDS-R score-, MMSE score-, duration of the dementia-, matched control group carrys on being treated as an outpaint without TV telephone communication.
Key exclusion criteria Not dementia, Difficulty in speaking
Target sample size 30

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Ayae Kinoshita
Organization Kyoto Univesity
Division name Home medical care nursing
Zip code
Address 53 Shogoin Kawahara-cho, Sakyo-ku Kyoto
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name
Organization Kyoto University
Division name Medical ethics committee
Zip code
Address 54 Shogoin Kawahara-cho, Sakyo-ku Kyoto
TEL
Homepage URL
Email ethcom@kuhp.kyoto-u.ac.jp

Sponsor
Institute Department of Human Health Sciences, Graduate School of Medicine, Kyoto University
Institute
Department

Funding Source
Organization Ministry of Education, Culture, Sports, Science and Technology
Organization
Division
Category of Funding Organization
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
2011 Year 11 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 Preinitiation
Date of protocol fixation
2011 Year 10 Month 01 Day
Date of IRB
Anticipated trial start date
2011 Year 11 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2011 Year 10 Month 14 Day
Last modified on
2011 Year 10 Month 14 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007753

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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