NCT03143699

Brief 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 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
120

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2017

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 28, 2017

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

May 4, 2017

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 8, 2017

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 6, 2017

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2018

Completed
Last Updated

August 3, 2017

Status Verified

May 1, 2017

Enrollment Period

7 months

First QC Date

May 4, 2017

Last Update Submit

August 1, 2017

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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)

    3 months

Secondary Outcomes (1)

  • Assess blood-pressure measurement knowledge

    3 months

Study Arms (2)

Immediate feedback

EXPERIMENTAL

Submitted to a training on blood pressure measurement skills and an immediate feedback after their encounter with an standardized patient - SP

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

Interventions

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.

Immediate feedback

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • students officially registered in the first semester of the medical school and older than 18 years old.

You may not qualify if:

  • those absent in any part of the blood pressure measurement training and those who not signed the consent term

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculdade de Ciências Médicas e da Saúde de Juiz de Fora

Juiz de Fora, Minas Gerais, 36.010-560, Brazil

RECRUITING

Study Officials

  • Giancarlo Lucchetti, MD, PhD

    Federal University of Juiz de Fora

    STUDY DIRECTOR

Central Study Contacts

Margareth AB e Castro, RN

CONTACT

Oscarina S Ezequiel, MD, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 4, 2017

First Posted

May 8, 2017

Study Start

March 28, 2017

Primary Completion

November 6, 2017

Study Completion

February 28, 2018

Last Updated

August 3, 2017

Record last verified: 2017-05

Data Sharing

IPD Sharing
Will not share

Locations