The development and evaluation of social participation on burn survivors in Japan

Development and validation of Japanese-language LIBRE Profile-SF which was a patient-reported outcome measure to evaluate social participation of burn survivors - LIBRE study in Japan

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000041701

Enrollment

110

Registered

2020-09-07

Start date

2020-08-03

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Burn injury

Interventions

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

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.

Exclusion criteria

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.

Design outcomes

Primary

Measure	Time frame
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.	—

Measure

Time frame

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.

—

Countries

Japan

Contacts

Public ContactYukio Sato

Keio University, School of Medicine Emergency and Critical Care Medicine

yukiosato.a6@keio.jp03-3225-1323

Outcome results