- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03143699
The Effect of Immediate Feedback on Long-term Blood Pressure Measurement Skills: a Randomized Controlled Trial
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Minas Gerais
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Juiz de Fora, Minas Gerais, Brazil, 36.010-560
- Recruiting
- Faculdade de Ciências Médicas e da Saúde de Juiz de Fora
-
Contact:
- Margareth Alves Bastos e Castro, Student
- Phone Number: +55 32998193700
- Email: maghms@terra.com.br
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion criteria:
- students officially registered in the first semester of the medical school and older than 18 years old.
Exclusion criteria:
- those absent in any part of the blood pressure measurement training and those who not signed the consent term
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Immediate feedback
Submitted to a training on blood pressure measurement skills and an immediate feedback after their encounter with an standardized patient - SP
|
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.
|
|
No Intervention: Students with no immediate feedback
Submitted to a training on blood pressure measurement skills, but without an immediate feedback after their encounter with an standardized patient - SP
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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)
|
3 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Assess blood-pressure measurement knowledge
Time Frame: 3 months
|
Blood pressure measurement knowledge test - following the criteria adopted by international (Eighth Joint National Committee) and the Brazilian guidelines (VII Brazilian Guidelines on Hipertension)
|
3 months
|
Collaborators and Investigators
Investigators
- Study Director: Giancarlo Lucchetti, MD, PhD, Federal University of Juiz de Fora
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 1.712.520
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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