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.: PACTR202211594568574 Date of Approval: 03/11/2022
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Evaluation of acceptance and effectiveness of using Virtual Patient cases in e-learning modules for training of medical licentiate practitioners in Zambia, Africa
Official scientific title Evaluation of acceptance and effectiveness of using Virtual Patient cases in e-learning modules for training of medical licentiate practitioners in Zambia, Africa
Brief summary describing the background and objectives of the trial The trial aims to compare different learning methods, such as self-developed virtual patients, textbooks, amboss (medical learning webpage) and free internet research, in their effectiveness as a learning tool for medical-licentiate students of year 3 and 4 from the Levy Mwanawasa Medical University in Zambia
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Paediatrics,Surgery
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Education /Training
Anticipated trial start date 10/12/2021
Actual trial start date 10/12/2021
Anticipated date of last follow up 10/12/2021
Actual Last follow-up date 10/12/2021
Anticipated target sample size (number of participants) 69
Actual target sample size (number of participants) 63
Recruitment status Completed
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 Randomised Stratified allocation where factors such as age, gender, center, or previous treatment are used in the stratification 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 Virtual patient cases once 30 minutes The participants allocated to the experimental group "Virtual patient cases" were asked to study a given medical topic, which was either Appendicits or Severe acute Malnutrition in the time period of 30 minutes. Before starting their studying time, participants were asked to take a pre-test after the intervention they were given a post-test. The improvement rate of this group was then compared to the improvement rate ot the control groups. There were 8 participants allocated to study the topic of Appendicitis and 8 participants were asked to study the topic severe acute malnutrition. 16
Control Group Amboss once 30 minuters The participants allocated to this group were asked to study a given medical topic, which was either the topic Severe acute malnutrition or Appendicitis by using the medical learning platform Amboss.com. Before starting their studying period they took a pretest and a posttest afer the studying period. The aim was to gather the improvement rate of each group in order to compare. 8 participants were asked to study the topic of Appendicitis and 8 participants were asked to study the topic of Severe acute malnutrition 16 Active-Treatment of Control Group
Control Group text book once 30 minutes The participants allocated to this group were asked to study a given medical topic, which was either the topic Severe acute malnutrition or Appendicitis by using text book pages. Before starting their studying period they took a pretest and a posttest afer the studying period. The aim was to gather the improvement rate of each group in order to compare. 8 participants were asked to study the topic of Appendicitis and 7 participants were asked to study the topic of Severe acute malnutrition 15 Active-Treatment of Control Group
Control Group free internet research once 30 minutes The participants allocated to this group were asked to study a given medical topic, which was either the topic Severe acute malnutrition or Appendicitis by doing free internet reseach on a given tablet. Before starting their studying period they took a pretest and a posttest afer the studying period. The aim was to gather the improvement rate of each group in order to compare. 8 participants were asked to study the topic of Appendicitis and 8 participants were asked to study the topic of Severe acute malnutrition 16 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Students of the BSc Clinical Sciences Program at the LMMU, third and fourth year Provided written informed consent to participate At least 18 years old Anyone who is not a student of the BSc Clinical Sciences Program at the LMMU, third and fourth year Any student who did not provide written informed consent to participate Adult: 19 Year-44 Year 18 Year(s) 45 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 15/09/2021 Ethikkomission der med. Fakultaet Heidelberg
Ethics Committee Address
Street address City Postal code Country
Alte Glockengiesserei 11/1 Heidelberg 69115 Germany
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 29/11/2021 Levy Mwanawaza medical university research ethics comittee
Ethics Committee Address
Street address City Postal code Country
Chainama Area Lusaka 33991 Zambia
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Reaction: Satisfaction of learning (self-reported) Learning: knowledge acquisition (self-reported) Behavior: Ability to transfer knowledge acquired to real-life situations Results: Impact of training on broader organizational goals and structures Directly after intervention
Secondary Outcome general acceptance ot the learning tools Directly after intervention
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Levy Mwanawaza medical universtiy Great East Road, Chainama Area. Lusaka 3991 Zambia
FUNDING SOURCES
Name of source Street address City Postal code Country
Heidelberg Institute of Global Health In Neuenheimer Feld 130.3 Heidelberg 69120 Germany
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Heidelberg Institute of Global Health In Neuenheimer Feld 130.3 Heidelberg 69120 Germany University
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Sandra Barteit barteit@uni-heidelberg.de +4962215634030 In Neuenheimer Feld 130.3
City Postal code Country Position/Affiliation
Heidelberg 69120 Germany Researcher
Role Name Email Phone Street address
Public Enquiries Sandra Barteit barteit@uni-heidelberg.de +4962215634030 In Neuenheimer Feld 130.3
City Postal code Country Position/Affiliation
Heidelberg 69120 Germany Researcher
Role Name Email Phone Street address
Scientific Enquiries Sandra Barteit barteit@uni-heidelberg.de +4962215634030 In Neuenheimer Feld 130.3
City Postal code Country Position/Affiliation
Heidelberg 69120 Germany Researcher
Role Name Email Phone Street address
Principal Investigator Natasha Namuziya natashanamuziya@gmail.com +260977417860 Levy Mwanawasa University Teaching Hospital
City Postal code Country Position/Affiliation
Lusaka 33991 Zambia Researcher
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Individual participant data will be available in the report after deidenfication process. Study Protocol 2 years open access
URL Results Available Results Summary Result Posting Date First Journal Publication Date
Yes 27/10/2022
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result - 27/10/2022
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information