UMIN-CTR Clinical Trial

Basic information
Public title	Consideration of the effect of ocular telemedicine utilizing video conferencing telemedical consultation system
Acronym	Consideration of the effect of ocular telemedicine
Scientific Title	Consideration of the effect of ocular telemedicine utilizing video conferencing telemedical consultation system
Scientific Title:Acronym	Consideration of the effect of ocular telemedicine
Region	Japan

Condition
Condition	Ocular disease
Classification by specialty	Ophthalmology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To consider the ocular telemedical care contributes for the physical and psychological condition of the patients in the home care and remote community To examine whether the mental and physical burden of patients and their families can be obtained by ocular telemedical care. To examine the economic effects, such as reduction of medical costs and transportation accommodation expenses for hospital visits by ocular telemedical care.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Patient questionnaire Attendant questionnaire (First and final round)
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	Diagnosis
Type of intervention	Other
Interventions/Control_1	Medical advice provided by the telemedical examination Period: from;the first support Date to;support end date Number of times: one provision of tele-medical advice for each remote consultation Advice item: eye findings, laboratory data, medication content, adaptation of surgery
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	Not applicable
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	The patients undergoing ophthalmic care in telemedicine alliance participation facilities in Hokkaido with telemedical support of Asahikawa Medical University hospital; 1. Patients received the ocular surgery at Asahikawa Medical University hospital and continue the post-operative observation in the region hospital. 2. Ophthalmological chronic disease patients treating continuously in the region hospital with indication of Asahikawa Medical University hospital. 3. Ophthalmological emergency patients with emergency telemedical support of Asahikawa Medical University hospital.
Key exclusion criteria	1. Patients can not be obtained the consent of implementation of ocular telemedical support. 2. Patients the physician determines unsuitable for a subject.
Target sample size	45

Research contact person
Name of lead principal investigator	1st name Kazuomi Middle name Last name Hanada
Organization	Asahikawa Medical University
Division name	Department of Medicine and Engineering Combined Research Institute
Zip code	078-8510
Address	2-1-1 Midorigaokahigashi, Asahikawa, Hokkaido, Japan
TEL	0166-68-2543
Email	hanada@asahikawa-med.ac.jp

Public contact
Name of contact person	1st name Kazuomi Middle name Last name Hanada
Organization	Asahikawa Medical University
Division name	Department of Medicine and Engineering Combined Research Institute
Zip code	078-8510
Address	2-1-1 Midorigaokahigashi, Asahikawa, Hokkaido, Japan
TEL	0166-68-2543
Homepage URL
Email	hanada@asahikawa-med.ac.jp

Sponsor
Institute	Department of Medicine and Engineering Combined Research Institute, Asahikawa Medical University
Institute
Department

Funding Source
Organization	Department of Medicine and Engineering Combined Research Institute, Asahikawa Medical University
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	Department of Medicine and Engineering Combined Research Institute, Asahikawa Medical University
Address	2-1-1 Midorigaokahigashi, Asahikawa, Hokkaido, Japan
Tel	0166-68-2543
Email	hanada@asahikawa-med.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	2016 Year 03 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	Open public recruiting
Date of protocol fixation	2016 Year 02 Month 29 Day
Date of IRB	2016 Year 03 Month 01 Day
Anticipated trial start date	2016 Year 03 Month 01 Day
Last follow-up date	2019 Year 09 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	2016 Year 02 Month 25 Day
Last modified on	2019 Year 08 Month 29 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000024447