Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR202001504666847 Date of Approval: 31/01/2020
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Evaluation of a digitally enhanced cardiac auscultation learning method: a controlled study
Official scientific title Evaluation of a digitally enhanced cardiac auscultation learning method: a controlled study
Brief summary describing the background and objectives of the trial Despite the development of modern diagnostic tools such as cardiac ultrasound, the mastery of auscultation remains a major challenge for health professionals given its effectiveness, efficiency and accessibility, particularly in countries with limited resources. However, several studies have shown that the cardiac auscultation skills of medical students and physicians at all levels of training are below average mainly because of an ineffective teaching method for this technique. The purpose of this study is to assess the relevance of a learning method that integrates the benefits of theoretical education, clinical internship and information technologies (digital audio recording and repetitive listening) on learners’ knowledge and skills.
Type of trial CCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Cardiology
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Education /Training
Anticipated trial start date 01/09/2021
Actual trial start date 01/09/2021
Anticipated date of last follow up 01/03/2022
Actual Last follow-up date 01/03/2022
Anticipated target sample size (number of participants) 70
Actual target sample size (number of participants)
Recruitment status Not yet recruiting
Publication URL
Secondary Ids Issuing authority/Trial register
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Parallel: different groups receive different interventions at same time during study Non-randomised Allocation was determined by the holder of the sequence who is situated off site Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Additional lectures and single clinical internship plus listening sessions Three (03) additional lectures A single clinical internship Two listening sessions One (1) hour per lectures Sixty (60) days for the clinical internship One (1) hour per listening session Additional lectures: Three additional lectures will be prepared by research team in agreement with a scientific committee composed of cardiologists. These lectures aim at supporting the normal lectures delivered in these faculties. The first course will focus on the anatomical and physiological bases of the heart, the second on cardiac semiology and the third on cardiac auscultation. These courses will take place at the FMBS and will be delivered in two sessions: the first course (first session) will take place on the same day as the recruitment of participants, the second and third course (second session) will take place two or three days after the first. Each course will be administered using PowerPoint presentation software and will have a duration of one hour. Clinical internships: Participants in the intervention group will be required to participate in their official clinical internship (internal medicine) as planned by their training school. This internship will take place in all the hospitals in Yaoundé that are accredited by the FMBS. It will start after the delivery of additional lectures, over a period of two months. Listening sessions: Five (5) digital audio recordings from real patients will be selected from a cardiac auscultation database designed in Cameroon in 2017. Two listening sessions of these digital audio recordings will be held in an FMBS classroom (one hour per session). Each recording corresponds to a specific cardiac sound and lasts for one (1) minute; the target cardiac sounds are as follows: heart sounds B1 and B2, aortic stenosis murmur, third heart sound (B3), fine crackles of heart failure and atrial fibrillation murmur. A multimedia package containing the additional lectures and the 5 digital audio recordings will be designed and made available to each participant in the intervention group at the end of the second listening session. SMS reminders will be sent to participants to encourage them to use this support. 35
Control Group Additional lectures and single clinical internship Three (3) additional lectures and a single clinical internship in internal medicine Three hours (one hour per lecture) Sixty (60) days (clinical internship) The training of cardiac auscultation in the control group will be done by the conventional method (association of lectures and a clinical internship). As in the intervention group, participants will also attend three additional lectures on anatomical and physiological bases of the heart, cardiac semiology and cardiac auscultation respectively. These courses will take place at the HIMT and will be delivered in two sessions: the first course (first session) will take place on the same day as the recruitment of participants, the second and third course (second session) will take place two or three days after the first. Each course will be administered using PowerPoint presentation software and will have a duration of one hour (30 minutes of teaching and 30 minutes of question-and-answer session). These are courses given in addition to the normal theoretical training program corresponding to the normal 4th year medical studies program. These courses are delivered in addition to the normal theoretical training program corresponding to 4th year medical studies. Participants in the control group will be required to participate in their official clinical internship (internal medicine) also as planned by their training school. This internship will take place in all the hospitals in Yaoundé that are accredited by the HIMT and will start after the delivery of additional lectures, over a period of two months. 35 Uncontrolled
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
4th year medical students Non repeater No prior clinical internship (internal medicine) Non-participation in theoretical courses Non-participation in both listening sessions Non-participation in the clinical internship Non-participation in both knowledge and skills assessments Withdrawal of informed consent Adult: 19 Year-44 Year 19 Year(s) 30 Year(s) Both
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 15/10/2019 Centre Regional Ethics Committee for Human Health Research
Ethics Committee Address
Street address City Postal code Country
Nlongkak Yaoundé 0000 Cameroon
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome The primary outcome will be the progression of participants’ knowledge in cardiac auscultation. It will be evaluated on the basis of the difference between the participants’ knowledge score in the post-test and the participants’ knowledge score in the pre-test. At the end of the study
Secondary Outcome The progression of participants’ skills in cardiac auscultation (based on the difference between the participants’ skill score in the post-test and the participants’ skill score in the pre-test) At the end of the study
Secondary Outcome The total progression of participants’ knowledge and skills in cardiac auscultation (based on the difference between the total score obtained by the participants in the post-test and the total score obtained in the pre-test) At the end of the study
Secondary Outcome The learners’ satisfaction with the use of each of these learning methods At the end of the study
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Faculty of Medicine and Biomedical Sciences of the University of Yaounde I Melen Yaounde Cameroon
Higher Institute of Medical Technologies Nkolondom Yaounde Cameroon
FUNDING SOURCES
Name of source Street address City Postal code Country
Dr Georges Bediang Melen Yaounde Cameroon
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Bediang Georges Melen Yaounde Cameroon Individual
COLLABORATORS
Name Street address City Postal code Country
Georges Bediang Melen Yaounde Cameroon
Chris Nganou Melen Yaounde Cameroon
Fred Goethe Melen Yaounde Cameroon
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Goethe Doualla Fred Cyrille fred.cyrille.goethe@gmail.com 00237693875367 Melen
City Postal code Country Position/Affiliation
Yaounde Cameroon Faculty of Medicine and Biomedical Sciences
Role Name Email Phone Street address
Scientific Enquiries Bediang Georges bediang@yahoo.com 00237699588574 Melen
City Postal code Country Position/Affiliation
Yaounde Cameroon Faculty of Medicine and Biomedical Sciences
Role Name Email Phone Street address
Public Enquiries Bediang Georges bediang@yahoo.com 00237699588574 Melen
City Postal code Country Position/Affiliation
Yaounde Cameroon Faculty of Medicine and Biomedical Sciences
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Individual participant data that underlie the result of this study, after deidentification (text, tables,figures, study protocol and analysis plan) will be shared. Statistical Analysis Plan,Study Protocol Immediately following publication, No end date. Access will be granted on the basis of the principal investigators' discretion
URL Results Available Results Summary Result Posting Date First Journal Publication Date
No
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information