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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000041701
Receipt No. R000047601
Scientific Title Development and validation of Japanese-language LIBRE Profile-SF which was a patient-reported outcome measure to evaluate social participation of burn survivors
Date of disclosure of the study information 2020/09/07
Last modified on 2020/09/06

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Basic information
Public title The development and evaluation of social participation on burn survivors in Japan
Acronym The study for burn survivors on social participation in Japan
Scientific Title Development and validation of Japanese-language LIBRE Profile-SF which was a patient-reported outcome measure to evaluate social participation of burn survivors
Scientific Title:Acronym LIBRE study in Japan
Region
Japan

Condition
Condition Burn injury
Classification by specialty
Surgery in general Plastic surgery Emergency medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Measuring the impact burn injuries have on social participation is integral to understanding and improving survivors' quality of life, yet there are no existing instruments that comprehensively measure the social participation of burn survivors in Japan. This project aimed to develop and validate the Japanese-language of Life Impact Burn Recovery Evaluation Profile (LIBRE), a multidimensional patient-reported outcome measures (PROM) for understanding the social participation after burn injuries in Japan, apply it to the burn survivors in Japan and analyze obtained data.
Basic objectives2 Others
Basic objectives -Others Reliability and validity
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes The outcomes for this study are defined in terms of the translations that will be performed. We define the outcomes in terms of the tasks involved in this 60 item translation of the LIBRE fixed form from the English to Japanese. The LIBRE Profile is designed to measure the degree of social participation and integration into the community after discharge from hospital for a traumatic burn injury. The outcomes for this work are specifically:
1. A validated and precise translation of the LIBRE Profile.
2. A validated and reliable set of assessments for the 6 LIBRE Profile domains or scales. These include: Social Activities, Social Interactions, Family and friends, work and employment, romantic relationships and sexual relationships.
Key secondary outcomes

Base
Study type Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
18 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Phase 1: The ten patients should represent a mix of burn subjects (a few with small burns (5% - <=20% Total Body Surface Area Burned (TBSA)) and a few with large burns (>20% TBSA) or burns of any size to any critical areas). These ten patients should a mix of sociodemographics (gender, race/ethnicity, and socioeconomic status), 18 years old and over the age of 18.
Phase 2&3: The hundred patients would be participated who meet the following criteria: 18 years old and over the age of 18; >5%TBSA burned or any size of burn injury on the face, hands, feet, genital area; living in Japan; being able to understand Japanese.
Key exclusion criteria The patients who meet the above inclusion criteria but do not agree the participation. The patients who could not be followed up during the study. The patients who have mental disorder.
Target sample size 110

Research contact person
Name of lead principal investigator
1st name Junichi
Middle name
Last name Sasaki
Organization Keio University, School of Medicine
Division name Emergency and Critical Care Medicine
Zip code 160-8582
Address 35, Shinanomachi, Shinjuku-ku, Tokyo, Japan
TEL 03-3353-1368
Email sasakij@1989.jukuin.keio.ac.jp

Public contact
Name of contact person
1st name Yukio
Middle name
Last name Sato
Organization Keio University, School of Medicine
Division name Emergency and Critical Care Medicine
Zip code 160-8582
Address 35, Shinanomachi, Shinjuku-ku, Tokyo, Japan
TEL 03-3225-1323
Homepage URL
Email yukiosato.a6@keio.jp

Sponsor
Institute Keio University, School of Medicine, Emergency and Critical Care Medicine
Institute
Department

Funding Source
Organization Keio 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 Keio University School of Medicine Ethics Committee
Address 35, Shinanomachi, Shinjuku-ku, Tokyo, Japan
Tel 03-3353-1211
Email med-rinri-jimu@adst.keio.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
2020 Year 09 Month 07 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 Enrolling by invitation
Date of protocol fixation
2020 Year 07 Month 10 Day
Date of IRB
2020 Year 08 Month 03 Day
Anticipated trial start date
2020 Year 08 Month 03 Day
Last follow-up date
2023 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Phase 1: This phase begins with a translation forward from English into Japanese and a translation back into English. Each identified individual will then translate the items from the LIBRE Profile from English (U.S.) to Japanese, each working independently. These individuals will then come together with a third party and review the translation of each of the items. Where there are differences in the translations, the third party will assist in resolving these differences. This same process will then be repeated as a backward translation, from Japanese back into English. Differences between the translations will be resolved for a final version of the translation.
Individuals familiar with burns and their treatment will administer the translated questionnaire to ten patients with burn injuries. If over the administration of LIBRE to ten different patients, two or more patients suggest revising the same item then the two clinician judges of the translations will make a final decision as to the revision of these selected items. This will be confirmed by the previously-mentioned third party. Based upon this process, a final version of the questionnaire will be confirmed and finalized for Phase 2.

Phase 2: the questionnaire will be administered to 100 subjects with burns. The population from which the sample will be drawn is made up of burn patients who have been discharged into the community and are being seen on an outpatient basis at the hospital. The LIBRE Short Form Profile will be administered together with the version of the SF-12, EQ-5D, or WHODAS. Then, psychometric analysis to check for the validity and reliability of the translated versions will be conducted.

Phase 3: Once the researcher has completed 100 questionnaires with subjects, they will follow up with 50 subjects who will complete a second administration two to four weeks later to examine test-retest reliability.

Management information
Registered date
2020 Year 09 Month 06 Day
Last modified on
2020 Year 09 Month 06 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047601

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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