NCT01379495

Brief Summary

The purpose of this study is to assess the effect of an educative program including telephone follow-up for burn patients regarding the impact of this intervention on the health status and return to work at six months after hospital discharge.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
83

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jul 2010

Typical duration for not_applicable

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, 2010

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

June 21, 2011

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 23, 2011

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2013

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2013

Completed
Last Updated

May 23, 2014

Status Verified

May 1, 2014

Enrollment Period

2.5 years

First QC Date

June 21, 2011

Last Update Submit

May 22, 2014

Conditions

Keywords

burnsrehabilitation

Outcome Measures

Primary Outcomes (1)

  • change from baseline in perceived health status at six months

    The questionnaire "Burns Specific Health Scale- Revised" developed by Blalock; Bunker; De Vellis (1994), adapted by Ferreira et al. (2008) to Brasilian people, will be used to collect the data at six months between groups.

    six months

Secondary Outcomes (1)

  • comparison the return to work of burn victims between groups

    baseline and six months

Study Arms (2)

Usual Care

NO INTERVENTION

Burns victims will receive information according to the service routine

educational program+telephone follow up

EXPERIMENTAL

Burns victims will participate in an educative program including telephone follow-up during six months after hospital discharge

Behavioral: educational program+telephone follow up

Interventions

burns victims will participate in an educative program including telephone follow-up during six months after hospital discharge

educational program+telephone follow up

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • adult burned patients (18 years or older), male and female
  • patients burned for the first time who needed hospitalization at the Burns Unit
  • in cognitive conditions to participate (being able to tell one's address, day of the week and age or birth date)
  • in physical conditions to accomplish self-care.

You may not qualify if:

  • participants burned due to suicide or with previous psychiatric diagnoses or cognitive and psychological difficulties that do not allow them to answer the instrument questions and take care of themselves.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Burns Unit of the University of São Paulo at Ribeirão Preto Hospital das Clínicas

Ribeirão Preto, São Paulo, 14015130, Brazil

Location

MeSH Terms

Conditions

Burns

Condition Hierarchy (Ancestors)

Wounds and Injuries

Study Officials

  • Natália Gonçalves, PhDcandidate

    University of Sao Paulo

    PRINCIPAL INVESTIGATOR
  • Lidia Ap Rossi, PhD

    University of São Paulo at Ribeirão Preto College of Nursing

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
CARE PROVIDER
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
RN, PhD student

Study Record Dates

First Submitted

June 21, 2011

First Posted

June 23, 2011

Study Start

July 1, 2010

Primary Completion

January 1, 2013

Study Completion

May 1, 2013

Last Updated

May 23, 2014

Record last verified: 2014-05

Locations