UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000002102 |
|---|---|
| Receipt number | R000002566 |
| Scientific Title | The support system for dementia patient with bidirectional IT communications |
| Date of disclosure of the study information | 2009/07/01 |
| Last modified on | 2009/12/28 09:29:17 |
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Basic information
Public title
The support system for dementia patient with bidirectional IT communications
Acronym
The support system for dementia patient with IT
Scientific Title
The support system for dementia patient with bidirectional IT communications
Scientific Title:Acronym
The support system for dementia patient with IT
Region
| Japan |
Condition
Condition
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 on preventing a further memory deterioration and reducing a caregiver burden.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Mini Mental State Examination (MMSE), HDS-R, Clinical dementia rating (CDR), Pines Burnout Scale, Zarit nursing-care burden scale, Philadelphia Geriatric Center(PGC) moral scale, Visual Analogue Scale (VAS)
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
Educational,Counseling,Training
Type of intervention
| Behavior,custom |
Interventions/Control_1
For a period of 12 weeks, a diabetic patient and his caregiver communicate with a doctor or nurse through the TV terephone for 30 minutes once a week. Intercommunication content are nursing-care consultation, compliance check, playing game together with dementia patient, exercise, recognition test, and so on.
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
| 73 | years-old | <= |
Age-upper limit
| 87 | 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
10
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
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
ethcom@kuhp.kyoto-u.ac.jp
Sponsor or person
Institute
Department of Human Health Sciences, Graduate School of Medicine, Kyoto University
Institute
Department
Personal name
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
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
| 2009 | Year | 07 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
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
Date of protocol fixation
| 2008 | Year | 03 | Month | 28 | Day |
Date of IRB
Anticipated trial start date
| 2008 | Year | 05 | Month | 01 | Day |
Last follow-up date
| 2009 | Year | 12 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2009 | Year | 06 | Month | 22 | Day |
Last modified on
| 2009 | Year | 12 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002566
