UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Telemedicine using smart glasses, wearable computer glasses, in patients with Parkinson's disease.
Title of the study (Brief title)	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	Teiichirou Miyazaki
Organization	Nagasaki University Hospital
Division name	Department of Neurology and Strokology
Address	1-7-1, Sakamoto, Nagasaki City, Nagasaki, Japan
TEL	095-819-7200
Email	teacomet@hotmail.com

Public contact
Name of contact person	Teiichirou Miyazaki
Organization	Nagasaki University Hospital
Division name	Department of Neurology and Strokology
Address	1-7-1, Sakamoto, Nagasaki City, Nagasaki, Japan
TEL	095-819-7200
Homepage URL
Email	teacomet@hotmail.com

Sponsor
Institute	Nagasaki University Hospital
Institute
Department

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)

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

Progress
Recruitment status	Preinitiation
Date of protocol fixation	2018 Year 09 Month 10 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038846