UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000034175 |
|---|---|
| Receipt number | R000038846 |
| Scientific Title | Telemedicine using smart glasses, wearable computer glasses, in patients with Parkinson's disease. |
| Date of disclosure of the study information | 2018/09/18 |
| Last modified on | 2018/09/18 00:43:13 |
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Basic information
Public title
Telemedicine using smart glasses, wearable computer glasses, in patients with Parkinson's disease.
Acronym
Telemedicine using smart glasses, wearable computer glasses, in patients with Parkinson's disease.
Scientific Title
Telemedicine using smart glasses, wearable computer glasses, in patients with Parkinson's disease.
Scientific Title:Acronym
Telemedicine using smart glasses, wearable computer glasses, in patients with Parkinson's disease.
Region
| Japan |
Condition
Condition
Parkinson's disease
Classification by specialty
| Neurology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We will test the usefulness of telemedicine (D to D to P) by smart glasses for patients with Parkinson's disease.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
MDS-UPDRS
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
Self control
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
A local doctor (non-specialist) carries out regular medical examination for patients who live in a detached island diagnosed Parkinson's disease once a month for 6 months.This period is as the control period, and virtual specialized outpatient is held using smart glass followed by a neurologist in university hospital once a month for 6 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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients who satisfy all the following criteria are targeted.
1. The patient who desire a virtual expert clinic and can visit one year.
2. The patient who satisfy the criteria; by the Ministry of Health, Labor and Welfare Specific Disease Research Group, UK Parkinson 's Disease Society Brain Bank Criteria (1992), or diagnostic criteria of Movement Disorder Society (MDS).
3. Outpatient.
4. 20 years old or over.
5. Gender does not matter.
6. The patient who consent to join this research with full understanding.
Key exclusion criteria
Patients applicable to even one of the following are excluded as subjects.
1. The patient who is in the outpatient specialized in neurology
2. The patients who do not wish to have a virtual nerve specialized clinic
3. The patients who were judged inappropriate as researchers
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Teiichirou Miyazaki |
Organization
Nagasaki University Hospital
Division name
Department of Neurology and Strokology
Zip code
Address
1-7-1, Sakamoto, Nagasaki City, Nagasaki, Japan
TEL
095-819-7200
teacomet@hotmail.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Teiichirou Miyazaki |
Organization
Nagasaki University Hospital
Division name
Department of Neurology and Strokology
Zip code
Address
1-7-1, Sakamoto, Nagasaki City, Nagasaki, Japan
TEL
095-819-7200
Homepage URL
teacomet@hotmail.com
Sponsor or person
Institute
Nagasaki University Hospital
Institute
Department
Personal name
Funding Source
Organization
Ministry of Education, Culture, Sports, Science and Technology
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
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
| 2018 | Year | 09 | Month | 18 | 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
| 2018 | Year | 09 | Month | 10 | Day |
Date of IRB
Anticipated trial start date
| 2018 | Year | 09 | Month | 18 | 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
| 2018 | Year | 09 | Month | 18 | Day |
Last modified on
| 2018 | Year | 09 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000038846
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
