Back to resultsEducation Program for Burn Patients
Primary Purpose
Burns
Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
educational program+telephone follow up
Sponsored by
About this trial
This is an interventional supportive care trial for Burns focused on measuring burns, rehabilitation
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Sites / Locations
- Burns Unit of the University of São Paulo at Ribeirão Preto Hospital das Clínicas
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Experimental
Arm Label
Usual Care
educational program+telephone follow up
Arm Description
Burns victims will receive information according to the service routine
Burns victims will participate in an educative program including telephone follow-up during six months after hospital discharge
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
comparison the return to work of burn victims between groups
To compare the return to work of burns victims in intervention group with the return to work of burns victims in control group at six months after hospital discharge, proportions will be calculated (returned to work: yes/no)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01379495
Brief Title
Education Program for Burn Patients
Official Title
Randomized Controlled Clinical Trial on Telephone Follow-up in Rehabilitation of Burn Patients: Impact on Health Status
Study Type
Interventional
2. Study Status
Record Verification Date
May 2014
Overall Recruitment Status
Completed
Study Start Date
July 2010 (undefined)
Primary Completion Date
January 2013 (Actual)
Study Completion Date
May 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Sao Paulo
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Burns
Keywords
burns, rehabilitation
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Care Provider
Allocation
Randomized
Enrollment
83 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Usual Care
Arm Type
No Intervention
Arm Description
Burns victims will receive information according to the service routine
Arm Title
educational program+telephone follow up
Arm Type
Experimental
Arm Description
Burns victims will participate in an educative program including telephone follow-up during six months after hospital discharge
Intervention Type
Behavioral
Intervention Name(s)
educational program+telephone follow up
Intervention Description
burns victims will participate in an educative program including telephone follow-up during six months after hospital discharge
Primary Outcome Measure Information:
Title
change from baseline in perceived health status at six months
Description
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.
Time Frame
six months
Secondary Outcome Measure Information:
Title
comparison the return to work of burn victims between groups
Description
To compare the return to work of burns victims in intervention group with the return to work of burns victims in control group at six months after hospital discharge, proportions will be calculated (returned to work: yes/no)
Time Frame
baseline and six months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Natália Gonçalves, PhDcandidate
Organizational Affiliation
University of São Paulo
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Lidia Ap Rossi, PhD
Organizational Affiliation
University of São Paulo at Ribeirão Preto College of Nursing
Official's Role
Study Chair
Facility Information:
Facility Name
Burns Unit of the University of São Paulo at Ribeirão Preto Hospital das Clínicas
City
Ribeirão Preto
State/Province
São Paulo
ZIP/Postal Code
14015130
Country
Brazil
12. IPD Sharing Statement
Learn more about this trial
Education Program for Burn Patients
We'll reach out to this number within 24 hrs