BurnsNCT01379495
Education Program for Burn Patients
A study testing educational program+telephone follow up in people with Burns, run by University of Sao Paulo at 1 site in Brazil.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Burns
- What is being tested?
- educational program+telephone follow up
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 83 participants
- Where
- 1 siteBrazil
- Study dates
- Jul 2010to May 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Burns Unit of the University of São Paulo at Ribeirão Preto Hospital das Clínicas
Ribeirão Preto, São Paulo, 14015130
About this study
Official title: 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.
- Conditions
- Burns
- Being tested
- educational program+telephone follow up
- Keywords
- burns, rehabilitation
- Medical subject headings
- Burns
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
educational program+telephone follow upBehavioural
burns victims will participate in an educative program including telephone follow-up during six months after hospital discharge
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Behavioral: educational program+telephone follow up |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: six months
Secondary outcomes (1)
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)
Measured: baseline and six months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2011 (estimated)
- Study startJul 2010
- Primary completionJan 2013
- Study completionMay 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BurnsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 83 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Natalia Gocalves, University of Sao Paulo
- Investigators
- Natália Gonçalves, PhDcandidate, Principal investigator, University of Sao PauloLidia Ap Rossi, PhD, Study chair, University of São Paulo at Ribeirão Preto College of Nursing
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01379495
- Sponsor's protocol ID
- uspqueimados2011
- Status last verified
- May 2014
- First submitted
- 21 Jun 2011
- Last updated
- 23 May 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 23 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled Clinical Trial on Telephone Follow-up in Rehabilitation of Burn Patients: Impact on Health Status
- ClinicalTrials.gov ID
- NCT01379495
- Acronym / sponsor ID
- uspqueimados2011
- Conditions
- Burns
- Keywords
- burns, rehabilitation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 83 participants (actual)
- Lead sponsor
- University of Sao PauloUniversity, hospital or other
- Study start
- Jul 2010
- Primary completion
- Jan 2013 (actual)
- Study completion
- May 2013 (actual)
- First posted
- 23 Jun 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Usual Care | No intervention | –Burns victims will receive information according to the service routine |
| educational program+telephone follow up | Experimental | Behavioral: educational program+telephone follow upBurns victims will participate in an educative program including telephone follow-up during six months after hospital discharge |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| educational program+telephone follow upburns victims will participate in an educative program including telephone follow-up during six months after hospital discharge | Behavioural | educational program+telephone follow up |
Primary outcome
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.
1 secondary outcome
comparison the return to work of burn victims between groups
Time frame: baseline and six months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 May 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Natália Gonçalves, PhDcandidate principal investigator
University of Sao Paulo
Lidia Ap Rossi, PhD study chair
University of São Paulo at Ribeirão Preto College of Nursing
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing educational program+telephone follow up in people with Burns, run by University of Sao Paulo at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 May 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
change from baseline in perceived health status at six months (time frame: six months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 May 2014.