NCT02950675

Brief Summary

The relationship of body function, participation and quality of life in patients with burn: A longitudinal study

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
79

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jul 2016

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2016

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

October 10, 2016

Completed
22 days until next milestone

First Posted

Study publicly available on registry

November 1, 2016

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2019

Completed
Last Updated

February 2, 2021

Status Verified

January 1, 2019

Enrollment Period

3 years

First QC Date

October 10, 2016

Last Update Submit

January 31, 2021

Conditions

Burn

Keywords

Burn patientDevelopmental DisabilitiesBody functionParticipationQuality of Lifelongitudinal study

Outcome Measures

Primary Outcomes (1)

  • Change in bodily function in baseline, 3 month, 12 month, 18 month, 24 month, 30 month and 36 month follow up

    Vancouver Scar Scale (VSS)

    baseline, 3 month, 12 month, 18 month, 24 month, 30 month and 36 month

Secondary Outcomes (4)

  • Change in muscle strength change in baseline, 3 month, 12 month, 18 month, 24 month, 30 month and 36 month follow up

    baseline, 3 month, 12 month, 18 month, 24 month, 30 month and 36 month

  • Change in activities of daily living in baseline, 3 month, 12 month, 18 month, 24 month, 30 month and 36 month follow up

    baseline, 3 month, 12 month, 18 month, 24 month, 30 month and 36 month

  • Change in individual independency in baseline, 3 month, 12 month, 18 month, 24 month, 30 month and 36 month follow up

    baseline, 3 month, 12 month, 18 month, 24 month, 30 month and 36 month

  • Change in quality of life in baseline, 3 month, 12 month, 18 month, 24 month, 30 month and 36 month follow up

    baseline, 3 month, 12 month, 18 month, 24 month, 30 month and 36 month

Study Arms (2)

Normal Adult

Control:Normal Adult

Burn Patient

The burn patient will be identified according to the diagnoses (ICD-9-CM code: 940-949).

Eligibility Criteria

Age14 Years - 74 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

The investigators will have Normal Adult (n=30\~40) and Burn Patient (n=80-90) from 14-74 years old under consent of their family.

You may qualify if:

  • Clinical diagnosis of burn injuries admitted to Burn Center or followed in burn clinic
  • Age \>14
  • No mental diseases
  • Understand written Chinese or could complete the questionnaires with staff's assistance

You may not qualify if:

  • Died during or after hospitalization
  • Refused to participate in the investigation
  • Concurrent medical illness that affecting the subjectivity of post burn sequelae (ex. progressive muscular or mental diseases, trauma or seizure)
  • Age \>74

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chang Gung Memorial Hospital

Taoyuan District, 333, Taiwan

Location

MeSH Terms

Conditions

BurnsDevelopmental Disabilities

Condition Hierarchy (Ancestors)

Wounds and InjuriesNeurodevelopmental DisordersMental Disorders

Study Officials

  • Katie P Wu, MD

    Chang Gung Memorial Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 10, 2016

First Posted

November 1, 2016

Study Start

July 1, 2016

Primary Completion

July 1, 2019

Study Completion

July 1, 2019

Last Updated

February 2, 2021

Record last verified: 2019-01

Data Sharing

IPD Sharing
Will not share

Locations

TW(1)