UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000021197 |
|---|---|
| Receipt number | R000024447 |
| Scientific Title | Consideration of the effect of ocular telemedicine utilizing video conferencing telemedical consultation system |
| Date of disclosure of the study information | 2016/03/01 |
| Last modified on | 2019/08/29 11:57:02 |
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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
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
hanada@asahikawa-med.ac.jp
Sponsor or person
Institute
Department of Medicine and Engineering Combined Research Institute,
Asahikawa Medical University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024447
