Education, MedicalNCT03143699
The Effect of Immediate Feedback on Long-term Blood Pressure Measurement Skills: a Randomized Controlled Trial
A study testing Immediate Feedback in people with Education, Medical and Blood Pressure, run by Federal University of Juiz de Fora at 1 site in Brazil.
Trial summary
The present study aims to investigate the effect of immediate feedback on long-term blood pressure measurement skills. This is a randomized controlled trial including first year students from a Brazilian medical school, which will be randomized in two groups: an intervention group (submitted to a training on blood… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Education, Medical, Blood Pressure
- What is being tested?
- Immediate Feedback
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteBrazil
- Study dates
- 28 Mar 2017to 28 Feb 2018
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- students officially registered in the first semester of the medical school and older than 18 years old.
Who cannot join
- those absent in any part of the blood pressure measurement training and those who not signed the consent term
Trial locations and contacts
1 site in 1 country.
Brazil1 site, 1 recruiting
- Recruiting
Faculdade de Ciências Médicas e da Saúde de Juiz de Fora
Juiz de Fora, Minas Gerais, 36.010-560
Margareth Alves Bastos e Castro, Student, 32998193700 ext. +55, maghms@terra.com.br
About this study
The present study aims to investigate the effect of immediate feedback on long-term blood pressure measurement skills. This is a randomized controlled trial including first year students from a Brazilian medical school, which will be randomized in two groups: an intervention group (submitted to a training on blood pressure measurement skills and an immediate feedback) and a control group (submitted to a training on blood pressure measurement skills, but with no immediate feedback). Then, students will be assessed 3 months after the feedback in order to see whether there will be a difference between groups. Our hypothesis is that students submitted to immediate feedback would have better scores in the blood-pressure measurement skills after 3 months. A knowledge questionnaire as well as a standardized patient scenario will be used to assess students' knowledge and skills.
Read the detailed description
There are several studies evaluating the role of feedback in medical education, showing promising outcomes. Although, immediate feedback is associated with better knowledge and skills in short-term, few studies have assessed whether immediate feedback could impact the maintenance of skills. The present study aims to investigate the effect of immediate feedback on long-term blood pressure measurement skills. This is a randomized controlled trial including first year students from a Brazilian medical school, which will be randomized in two groups: an intervention group (submitted to a training on blood pressure measurement skills and an immediate feedback after their encounter with an standardized patient - SP) and a control group (submitted to the same training on blood pressure measurement skills, but with no immediate feedback after the SP encounter).
Both groups will be trained to measure blood pressure in the same way, with a brief 4-hour theoretical-practical intervention. After the training, students will measure the blood pressure of a standardized patient and observers will evaluate them using a checklist.
Then, students will have no other exposure to the BP training for three months and they will be invited again to participate in another SP encounter. Differences on BP skills after 3 months between those exposed to immediate feedback and those not exposed to immediate feedback would be investigated.
- Conditions
- Education, Medical, Blood Pressure
- Being tested
- Immediate Feedback
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Immediate FeedbackOther
Students will be trained to measure blood pressure in the same way, with a brief 4-hour theoretical-practical intervention. After the training, students will measure the blood pressure of a standardized patient and observers will evaluate them using a checklist. After that, students from the intervention group will receive an immediate feedback based on the previous literature. Briefly, feedback will be based on what was directly observed and will be phrased in non-judgmental language, following the Pendleton model.
| Study group | Role | What they receive |
|---|---|---|
| Immediate feedback | Experimental | Submitted to a training on blood pressure measurement skills and an immediate feedback after their encounter with an standardized patient - SP Receives: Other: Immediate Feedback |
| Students with no immediate feedback | No intervention | Submitted to a training on blood pressure measurement skills, but without an immediate feedback after their encounter with an standardized patient - SP |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assess blood-pressure measurement skills
Blood pressure measurement skills checklist - following the criteria adopted by international (Eighth Joint National Committee) and the Brazilian guidelines (VII Brazilian Guidelines on Hipertension)
Measured: 3 months
Secondary outcomes (1)
Assess blood-pressure measurement knowledge
Blood pressure measurement knowledge test - following the criteria adopted by international (Eighth Joint National Committee) and the Brazilian guidelines (VII Brazilian Guidelines on Hipertension)
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2017
- Study start28 Mar 2017
- Primary completion6 Nov 2017 (estimated)
- Study completion28 Feb 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Education, MedicalStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Federal University of Juiz de Fora
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Giancarlo Lucchetti, MD, PhD, Study director, Federal University of Juiz de Fora
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03143699
- Sponsor's protocol ID
- 1.712.520
- Status last verified
- May 2017
- First submitted
- 4 May 2017
- Last updated
- 3 Aug 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Immediate Feedback on Long-term Blood Pressure Measurement Skills: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03143699
- Acronym / sponsor ID
- 1.712.520
- Conditions
- Education, Medical, Blood Pressure
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Federal University of Juiz de ForaUniversity, hospital or other
- Study start
- 28 Mar 2017 (actual)
- Primary completion
- 6 Nov 2017 (estimated)
- Study completion
- 28 Feb 2018 (estimated)
- First posted
- 8 May 2017 (actual)
- 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 present study aims to investigate the effect of immediate feedback on long-term blood pressure measurement skills. This is a randomized controlled trial including first year students from a Brazilian medical school, which will be randomized in two groups: an intervention group (submitted to a training on blood pressure measurement skills and an immediate feedback) and a control group (submitted to a training on blood pressure measurement skills, but with no immediate feedback). Then, students will be assessed 3 months after the feedback in order to see whether there will be a difference between groups. Our hypothesis is that students submitted to immediate feedback would have better scores in the blood-pressure measurement skills after 3 months. A knowledge questionnaire as well as a standardized patient scenario will be used to assess students' knowledge and skills.
Detailed description
There are several studies evaluating the role of feedback in medical education, showing promising outcomes. Although, immediate feedback is associated with better knowledge and skills in short-term, few studies have assessed whether immediate feedback could impact the maintenance of skills. The present study aims to investigate the effect of immediate feedback on long-term blood pressure measurement skills. This is a randomized controlled trial including first year students from a Brazilian medical school, which will be randomized in two groups: an intervention group (submitted to a training on blood pressure measurement skills and an immediate feedback after their encounter with an standardized patient - SP) and a control group (submitted to the same training on blood pressure measurement skills, but with no immediate feedback after the SP encounter).
Both groups will be trained to measure blood pressure in the same way, with a brief 4-hour theoretical-practical intervention. After the training, students will measure the blood pressure of a standardized patient and observers will evaluate them using a checklist.
Then, students will have no other exposure to the BP training for three months and they will be invited again to participate in another SP encounter. Differences on BP skills after 3 months between those exposed to immediate feedback and those not exposed to immediate feedback would be investigated.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Immediate feedback | Experimental | Other: Immediate FeedbackSubmitted to a training on blood pressure measurement skills and an immediate feedback after their encounter with an standardized patient - SP |
| Students with no immediate feedback | No intervention | –Submitted to a training on blood pressure measurement skills, but without an immediate feedback after their encounter with an standardized patient - SP |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- students officially registered in the first semester of the medical school and older than 18 years old.
Key exclusion criteria (1 listed)
- those absent in any part of the blood pressure measurement training and those who not signed the consent term
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 |
|---|---|---|
| Immediate FeedbackStudents will be trained to measure blood pressure in the same way, with a brief 4-hour theoretical-practical intervention. After the training, students will measure the blood pressure of a standardized patient and observers will evaluate them using a checklist. After that, students from the intervention group will receive an immediate feedback based on the previous literature. Briefly, feedback will be based on what was directly observed and will be phrased in non-judgmental language, following the Pendleton model. | Other | Immediate feedback |
Primary outcome
Assess blood-pressure measurement skills
Time frame: 3 months
Blood pressure measurement skills checklist - following the criteria adopted by international (Eighth Joint National Committee) and the Brazilian guidelines (VII Brazilian Guidelines on Hipertension)
1 secondary outcome
Assess blood-pressure measurement knowledge
Time frame: 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Aug 2017.
- Individual participant dataSharing planned: No
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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.
Giancarlo Lucchetti, MD, PhD study director
Federal University of Juiz de Fora
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Immediate Feedback in people with Education, Medical and Blood Pressure, run by Federal University of Juiz de Fora 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 1 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: status not confirmed, as of the sponsor's last update on 3 Aug 2017. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Margareth AB e Castro, RN (55(32)998193700, maghms@terra.com.br), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assess blood-pressure measurement skills (time frame: 3 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 3 Aug 2017.