Burns Clinical Trial
Official title:
Randomized Controlled Clinical Trial on Telephone Follow-up in Rehabilitation of Burn Patients: Impact on Health Status
| Verified date | May 2014 |
| Source | University of Sao Paulo |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | Brazil: National Committee of Ethics in Research |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 83 |
| Est. completion date | May 2013 |
| Est. primary completion date | January 2013 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years to 80 Years |
| Eligibility |
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. |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Caregiver), Primary Purpose: Supportive Care
| Country | Name | City | State |
|---|---|---|---|
| Brazil | Burns Unit of the University of São Paulo at Ribeirão Preto Hospital das Clínicas | Ribeirão Preto | São Paulo |
| Lead Sponsor | Collaborator |
|---|---|
| University of Sao Paulo |
Brazil,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 | Yes |
| Secondary | 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) | baseline and six months | Yes |
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