UMIN-CTR Clinical Trial

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

Burn injury

Classification by specialty

Surgery in general	Plastic surgery	Emergency medicine

Classification by malignancy

Others

Genomic information

NO

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

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

Study type

Observational

Basic design

Randomization

Randomization unit

Blinding

Control

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

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

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

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

Institute

Keio University, School of Medicine, Emergency and Critical Care Medicine

Institute

Department

Personal name

Organization

Keio University

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

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

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

慶應義塾大学病院（東京都）、国立病院機構東京医療センター（東京都）、国立病院機構熊本医療センター（熊本県）、沖縄県立中部病院（沖縄県）

Date of disclosure of the study information

2020

Year

09

Month

07

Day

URL releasing protocol

Publication of results

Unpublished

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

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

2025

Year

03

Month

31

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

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.

Registered date

2020

Year

09

Month

06

Day

Last modified on

2024

Year

03

Month

09

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047601