- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01379495
Education Program for Burn Patients
May 22, 2014 updated by: Natalia Gocalves, University of Sao Paulo
Randomized Controlled Clinical Trial on Telephone Follow-up in Rehabilitation of Burn Patients: Impact on Health Status
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
83
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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São Paulo
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Ribeirão Preto, São Paulo, Brazil, 14015130
- Burns Unit of the University of São Paulo at Ribeirão Preto Hospital das Clínicas
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 80 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
No Intervention: Usual Care
Burns victims will receive information according to the service routine
|
|
|
Experimental: educational program+telephone follow up
Burns victims will participate in an educative program including telephone follow-up during six months after hospital discharge
|
burns victims will participate in an educative program including telephone follow-up during six months after hospital discharge
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
change from baseline in perceived health status at six months
Time Frame: 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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
comparison the return to work of burn victims between groups
Time Frame: baseline and six months
|
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)
|
baseline and six months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Natália Gonçalves, PhDcandidate, University of Sao Paulo
- Study Chair: Lidia Ap Rossi, PhD, University of São Paulo at Ribeirão Preto College of Nursing
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
July 1, 2010
Primary Completion (Actual)
January 1, 2013
Study Completion (Actual)
May 1, 2013
Study Registration Dates
First Submitted
June 21, 2011
First Submitted That Met QC Criteria
June 21, 2011
First Posted (Estimate)
June 23, 2011
Study Record Updates
Last Update Posted (Estimate)
May 23, 2014
Last Update Submitted That Met QC Criteria
May 22, 2014
Last Verified
May 1, 2014
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- uspqueimados2011
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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