Blood PressureNCT05915039

Computer Assisted Learning (CAL) Module Use for Re-training of Blood Pressure Measurements by Physical Therapy Students

A study testing Computer Assisted Learning (CAL) Module in people with Blood Pressure, run by Youngstown State University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

The purpose of this study is to determine the effectiveness of a Computer Assisted Learning Module for supplemental blood pressure measurement retraining for doctor of physical therapy students. Read more about this study

Who is it for?: Ages 18 to 100 yearsHealthy volunteers can take part
Conditions the study is for: Blood Pressure
What is being tested?: Computer Assisted Learning (CAL) Module
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 39 participants
Where: 1 siteUnited States
Study dates: 20 Jul 2023to 1 Dec 2023
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 100 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

Current student enrolled in the DPT program
Student is in good standing academically
Student is enrolled in the Clinical Foundation Skills course for the first time
Student provided informed consent to participate

Who cannot join

Student not enrolled in the DPT program
Student is taking the Clinical Skills Foundation course for the 2nd time
Student is not in good academic standing
Student did not provide informed consent to participate

Trial locations and contacts

1 site in 1 country.

United States1 site

Youngstown State University
Youngstown, Ohio, 44555

Other trials in United States

About this study

Official title: Usage of a Computer Assisted Learning (CAL) Module for Supplemental Re-training of BP Measurements by Doctor of Physical Therapy Students

The purpose of this study is to determine the effectiveness of a Computer Assisted Learning Module for supplemental blood pressure measurement retraining for doctor of physical therapy students.

Conditions: Blood Pressure
Being tested: Computer Assisted Learning (CAL) Module
Keywords: Physical Therapy, Education, Teaching

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Computer Assisted Learning (CAL) ModuleOther
The students assigned to Group A will undergo interactive CAL module training by the American Medical Association which outlines how to properly measure blood pressure manually following the American Heart Association guidelines.

Study groups in NCT05915039
Study group	Role	What they receive
Group A	Experimental	This is the initial experimental group who will be exposed to the CAL module 48 hours before the first retesting period 2 months out from initial baseline measurement. Receives: Other: Computer Assisted Learning (CAL) Module
Group B	No intervention	This is the initial control group who will not be exposed to the CAL module 48 hours before the first retesting period 2 months out from initial baseline measurement.

What is being measured

The primary outcome is the main question the study is designed to answer.

Accuracy of blood pressure measurements
Pre-programmed manikin arms will be set to different blood pressure values. Students must correctly identify each of the pre-set blood pressure measurements
Measured: Baseline to 4 months
Confidence of blood pressure measurements
A 5-point Likert scale survey to assess student confidence in different aspects of measuring blood pressure. The scale ranges from 1 to 5 with the following values: 1 - Not confident at all, 2 - Slightly confident, 3 - Moderately confident, 4 - Very confident, and 5 - extremely confident. A higher score indicates that the individual has higher levels of confidence for the reported item.
Measured: Baseline to 4 months
Blood pressure measurement knowledge quiz
A knowledge quiz regarding the proper steps of blood pressure measurement as defined by the American Heart Association. This is a 15 question multiple choice quiz. The higher the score, the better the performance.
Measured: Baseline to 4 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

20 Jul 20231 Dec 2023

First posted22 Jun 2023
Study start20 Jul 2023
Primary completion1 Dec 2023
Study completion1 Dec 2023

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (13)Papers the sponsor has linked to this study.
Other trials for Blood PressureStudies 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: Crossover
Model description: This study will utilize a randomized crossover design. Students enrolled in this study will undergo traditional blood pressure training. The students will be randomly divided into 2 groups (control and experimental). All students will undergo baseline testing 2 weeks after the class. At 48 hours before the 2 month timepoint, the experimental group will complete a CAL module entitled: "BP Measurement: Student Essentials". The control group will not undergo any retraining activities. All students will retest for accuracy, confidence, and knowledge. At the second 2 month mark, the control group will complete the CAL module and the experimental group will not. All students will retest for accuracy, confidence, and knowledge. All participants, the faculty teaching BP, and outcome assessors will be blinded from knowledge of groups throughout to reduce bias risk.
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 39 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05915039
Sponsor's protocol ID: 2023-297
Status last verified: Jan 2024
First submitted: 13 Jun 2023
Last updated: 25 Jan 2024
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

Holmstrup M, Jensen B, Burkart R, Levis M. Using a novel assessment of procedural proficiency provides medical educators insight into blood pressure measurement. Int J Med Educ. 2016 Nov 19;7:375-381. doi: 10.5116/ijme.580b.2e4f.
PubMed 27864919
Gordon CJ, Frotjold A, Fethney J, Green J, Hardy J, Maw M, Buckley T. The effectiveness of simulation-based blood pressure training in preregistration nursing students. Simul Healthc. 2013 Oct;8(5):335-40. doi: 10.1097/SIH.0b013e3182a15fa7.
PubMed 24061336
Seybert AL, Barton CM. Simulation-based learning to teach blood pressure assessment to doctor of pharmacy students. Am J Pharm Educ. 2007 Jun 15;71(3):48. doi: 10.5688/aj710348.
PubMed 17619648
Bland M, Ousey K. Preparing students to competently measure blood pressure in the real-world environment: a comparison between New Zealand and the United Kingdom. Nurse Educ Pract. 2012 Jan;12(1):28-35. doi: 10.1016/j.nepr.2011.04.009. Epub 2011 Jun 8.
PubMed 21641869
Gazibara T, Rancic B, Maric G, Radovanovic S, Kisic-Tepavcevic D, Pekmezovic T. Medical students, do you know how to measure blood pressure correctly? Blood Press Monit. 2015 Feb;20(1):27-31. doi: 10.1097/MBP.0000000000000085.
PubMed 25243713
Rakotz MK, Townsend RR, Yang J, Alpert BS, Heneghan KA, Wynia M, Wozniak GD. Medical students and measuring blood pressure: Results from the American Medical Association Blood Pressure Check Challenge. J Clin Hypertens (Greenwich). 2017 Jun;19(6):614-619. doi: 10.1111/jch.13018. Epub 2017 Apr 28.
PubMed 28452119
Muntner P, Shimbo D, Carey RM, Charleston JB, Gaillard T, Misra S, Myers MG, Ogedegbe G, Schwartz JE, Townsend RR, Urbina EM, Viera AJ, White WB, Wright JT Jr. Measurement of Blood Pressure in Humans: A Scientific Statement From the American Heart Association. Hypertension. 2019 May;73(5):e35-e66. doi: 10.1161/HYP.0000000000000087.
PubMed 30827125
Gonzalez-Lopez JJ, Gomez-Arnau Ramirez J, Torremocha Garcia R, Albelda Esteban S, Alio del Barrio J, Rodriguez-Artalejo F. Knowledge of correct blood pressure measurement procedures among medical and nursing students. Rev Esp Cardiol. 2009 May;62(5):568-71. doi: 10.1016/s1885-5857(09)71840-7. English, Spanish.
PubMed 19406072
Crosley AM, Rose JR. Knowledge of accurate blood pressure measurement procedures in chiropractic students. J Chiropr Educ. 2013 Fall;27(2):152-7. doi: 10.7899/JCE-13-3. Epub 2013 Jun 27.
PubMed 23957320
Ibiyemi O, Ogunbodede O, Gbolahan OO, Ogah OS. Knowledge and practices of blood pressure measurement among final year students, house officers, and resident dental surgeons in a dental hospital, South West Nigeria. Niger J Clin Pract. 2020 Jun;23(6):848-856. doi: 10.4103/njcp.njcp_416_19.
PubMed 32525122
Rabbia F, Testa E, Rabbia S, Pratico S, Colasanto C, Montersino F, Berra E, Covella M, Fulcheri C, Di Monaco S, Buffolo F, Totaro S, Veglio F. Effectiveness of blood pressure educational and evaluation program for the improvement of measurement accuracy among nurses. High Blood Press Cardiovasc Prev. 2013 Jun;20(2):77-80. doi: 10.1007/s40292-013-0012-5. Epub 2013 May 8.
PubMed 23653174
Leung GK, Nicholls JM. Effect of clinical context on simulator-based assessment of blood pressure taking - a pilot randomized study. Med Teach. 2014 Feb;36(2):177-9. doi: 10.3109/0142159X.2013.849328. Epub 2013 Oct 24.
PubMed 24156287
Grim CM, Grim CE. A curriculum for the training and certification of blood pressure measurement for health care providers. Can J Cardiol. 1995 Nov;11 Suppl H:38H-42H.
PubMed 7489543

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 25 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Usage of a Computer Assisted Learning (CAL) Module for Supplemental Re-training of BP Measurements by Doctor of Physical Therapy Students
ClinicalTrials.gov ID: NCT05915039
Acronym / sponsor ID: 2023-297
Conditions: Blood Pressure
Keywords: Physical Therapy, Education, Teaching
Study type: Interventional
Recruitment status: Completed
Enrolment: 39 participants (actual)
Lead sponsor: Youngstown State UniversityUniversity, hospital or other
Study start: 20 Jul 2023 (actual)
Primary completion: 1 Dec 2023 (actual)
Study completion: 1 Dec 2023 (actual)
First posted: 22 Jun 2023 (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 purpose of this study is to determine the effectiveness of a Computer Assisted Learning Module for supplemental blood pressure measurement retraining for doctor of physical therapy students.

Study design

Primary purpose: Other
Allocation: Randomised
Intervention model: Crossover
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2
Model description: This study will utilize a randomized crossover design. Students enrolled in this study will undergo traditional blood pressure training. The students will be randomly divided into 2 groups (control and experimental). All students will undergo baseline testing 2 weeks after the class. At 48 hours before the 2 month timepoint, the experimental group will complete a CAL module entitled: "BP Measurement: Student Essentials". The control group will not undergo any retraining activities. All students will retest for accuracy, confidence, and knowledge. At the second 2 month mark, the control group will complete the CAL module and the experimental group will not. All students will retest for accuracy, confidence, and knowledge. All participants, the faculty teaching BP, and outcome assessors will be blinded from knowledge of groups throughout to reduce bias risk.

Arm	Type	Receives
Group A	Experimental	Other: Computer Assisted Learning (CAL) ModuleThis is the initial experimental group who will be exposed to the CAL module 48 hours before the first retesting period 2 months out from initial baseline measurement.
Group B	No intervention	–This is the initial control group who will not be exposed to the CAL module 48 hours before the first retesting period 2 months out from initial baseline measurement.

Who may qualify

Ages: 18 to 100 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

Current student enrolled in the DPT program
Student is in good standing academically
Student is enrolled in the Clinical Foundation Skills course for the first time
Student provided informed consent to participate

Key exclusion criteria (4 listed)

Student not enrolled in the DPT program
Student is taking the Clinical Skills Foundation course for the 2nd time
Student is not in good academic standing
Student did not provide informed consent to participate

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
Computer Assisted Learning (CAL) ModuleThe students assigned to Group A will undergo interactive CAL module training by the American Medical Association which outlines how to properly measure blood pressure manually following the American Heart Association guidelines.	Other	Group A

Primary outcome

Accuracy of blood pressure measurements
Time frame: Baseline to 4 months
Pre-programmed manikin arms will be set to different blood pressure values. Students must correctly identify each of the pre-set blood pressure measurements
Confidence of blood pressure measurements
Time frame: Baseline to 4 months
A 5-point Likert scale survey to assess student confidence in different aspects of measuring blood pressure. The scale ranges from 1 to 5 with the following values: 1 - Not confident at all, 2 - Slightly confident, 3 - Moderately confident, 4 - Very confident, and 5 - extremely confident. A higher score indicates that the individual has higher levels of confidence for the reported item.
Blood pressure measurement knowledge quiz
Time frame: Baseline to 4 months
A knowledge quiz regarding the proper steps of blood pressure measurement as defined by the American Heart Association. This is a 15 question multiple choice quiz. The higher the score, the better the performance.

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 25 Jan 2024.
Background: PubMed 27864919Holmstrup M, Jensen B, Burkart R, Levis M. Using a novel assessment of procedural proficiency provides medical educators insight into blood pressure measurement. Int J Med Educ. 2016 Nov 19;7:375-381. doi: 10.5116/ijme.580b.2e4f.
Background: PubMed 24061336Gordon CJ, Frotjold A, Fethney J, Green J, Hardy J, Maw M, Buckley T. The effectiveness of simulation-based blood pressure training in preregistration nursing students. Simul Healthc. 2013 Oct;8(5):335-40. doi: 10.1097/SIH.0b013e3182a15fa7.
Background: PubMed 17619648Seybert AL, Barton CM. Simulation-based learning to teach blood pressure assessment to doctor of pharmacy students. Am J Pharm Educ. 2007 Jun 15;71(3):48. doi: 10.5688/aj710348.
Background: PubMed 21641869Bland M, Ousey K. Preparing students to competently measure blood pressure in the real-world environment: a comparison between New Zealand and the United Kingdom. Nurse Educ Pract. 2012 Jan;12(1):28-35. doi: 10.1016/j.nepr.2011.04.009. Epub 2011 Jun 8.
Background: PubMed 25243713Gazibara T, Rancic B, Maric G, Radovanovic S, Kisic-Tepavcevic D, Pekmezovic T. Medical students, do you know how to measure blood pressure correctly? Blood Press Monit. 2015 Feb;20(1):27-31. doi: 10.1097/MBP.0000000000000085.
Background: PubMed 28452119Rakotz MK, Townsend RR, Yang J, Alpert BS, Heneghan KA, Wynia M, Wozniak GD. Medical students and measuring blood pressure: Results from the American Medical Association Blood Pressure Check Challenge. J Clin Hypertens (Greenwich). 2017 Jun;19(6):614-619. doi: 10.1111/jch.13018. Epub 2017 Apr 28.
Background: PubMed 30827125Muntner P, Shimbo D, Carey RM, Charleston JB, Gaillard T, Misra S, Myers MG, Ogedegbe G, Schwartz JE, Townsend RR, Urbina EM, Viera AJ, White WB, Wright JT Jr. Measurement of Blood Pressure in Humans: A Scientific Statement From the American Heart Association. Hypertension. 2019 May;73(5):e35-e66. doi: 10.1161/HYP.0000000000000087.
Background: PubMed 19406072Gonzalez-Lopez JJ, Gomez-Arnau Ramirez J, Torremocha Garcia R, Albelda Esteban S, Alio del Barrio J, Rodriguez-Artalejo F. Knowledge of correct blood pressure measurement procedures among medical and nursing students. Rev Esp Cardiol. 2009 May;62(5):568-71. doi: 10.1016/s1885-5857(09)71840-7. English, Spanish.
Background: PubMed 23957320Crosley AM, Rose JR. Knowledge of accurate blood pressure measurement procedures in chiropractic students. J Chiropr Educ. 2013 Fall;27(2):152-7. doi: 10.7899/JCE-13-3. Epub 2013 Jun 27.
Background: PubMed 32525122Ibiyemi O, Ogunbodede O, Gbolahan OO, Ogah OS. Knowledge and practices of blood pressure measurement among final year students, house officers, and resident dental surgeons in a dental hospital, South West Nigeria. Niger J Clin Pract. 2020 Jun;23(6):848-856. doi: 10.4103/njcp.njcp_416_19.
Background: PubMed 23653174Rabbia F, Testa E, Rabbia S, Pratico S, Colasanto C, Montersino F, Berra E, Covella M, Fulcheri C, Di Monaco S, Buffolo F, Totaro S, Veglio F. Effectiveness of blood pressure educational and evaluation program for the improvement of measurement accuracy among nurses. High Blood Press Cardiovasc Prev. 2013 Jun;20(2):77-80. doi: 10.1007/s40292-013-0012-5. Epub 2013 May 8.
Background: PubMed 24156287Leung GK, Nicholls JM. Effect of clinical context on simulator-based assessment of blood pressure taking - a pilot randomized study. Med Teach. 2014 Feb;36(2):177-9. doi: 10.3109/0142159X.2013.849328. Epub 2013 Oct 24.
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.

Edmund C Ickert, PhD principal investigator

Youngstown State University

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Computer Assisted Learning (CAL) Module in people with Blood Pressure, run by Youngstown State University at 1 site in United States.

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 4 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 25 Jan 2024. 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 United States. 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?

Accuracy of blood pressure measurements (time frame: Baseline to 4 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05915039, which also lists 13 linked publications.

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 25 Jan 2024.