UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000032714
Receipt No. R000037305
Scientific Title Do checklist-induced behavioral changes improve self-confidence in fundoscopy?
Date of disclosure of the study information 2018/05/31
Last modified on 2018/05/25

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information
Public title Do checklist-induced behavioral changes improve self-confidence in fundoscopy?
Acronym Do checklist-induced behavioral changes improve self-confidence in fundoscopy?
Scientific Title Do checklist-induced behavioral changes improve self-confidence in fundoscopy?
Scientific Title:Acronym Do checklist-induced behavioral changes improve self-confidence in fundoscopy?
Region
Japan

Condition
Condition Not applicable
Classification by specialty
Not applicable
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Fundoscopy is not often performed because of lack of confidence in the procedure due to insufficient experience. We hypothesized the introduction of a checklist for fundoscopy may motivate physicians to perform fundoscopy, resulting in the accumulation of experiences which would lead to building their confidence.
Basic objectives2 Others
Basic objectives -Others educational effect
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes The implementation ratio of fundoscopy was analyzed employing the chi-square test; the Visual Analog Scale (VAS) value for confidence, the corresponding t test; psychological factors extracted from the interview, the modified grounded theory approach.
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Cross-over
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Educational,Counseling,Training
Type of intervention
Other
Interventions/Control_1 A checklist was introduced to confirm that fundoscopy was performed during the intervention period.
Interventions/Control_2 A checklist was not introduced.
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
24 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria The participants were 13 general medicine physicians in charge of first visit outpatients.
Key exclusion criteria Among them, those who were unable to obtain consent and those who never took the first visit were excluded from the participants.
Target sample size 13

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Daiki Yokokawa
Organization Chiba University Hospital
Division name Department of General Medicine
Zip code
Address 1-8-1, Inohana, Chuo-ku, Chiba city, Chiba pref., Japan
TEL 043-222-7171
Email dyokokawa6@gmail.com

Public contact
Name of contact person
1st name
Middle name
Last name Daiki Yokokawa
Organization Chiba University Hospital
Division name Department of General Medicine
Zip code
Address 1-8-1, Inohana, Chuo-ku, Chiba city, Chiba pref., Japan
TEL 043-222-7171
Homepage URL
Email dyokokawa6@gmail.com

Sponsor
Institute Chiba University
Institute
Department

Funding Source
Organization none
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

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 05 Month 31 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 Completed
Date of protocol fixation
2016 Year 04 Month 01 Day
Date of IRB
Anticipated trial start date
2017 Year 04 Month 01 Day
Last follow-up date
2018 Year 03 Month 31 Day
Date of closure to data entry
2018 Year 03 Month 31 Day
Date trial data considered complete
2018 Year 07 Month 31 Day
Date analysis concluded
2019 Year 03 Month 31 Day

Other
Other related information

Management information
Registered date
2018 Year 05 Month 25 Day
Last modified on
2018 Year 05 Month 25 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037305

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.