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.: PACTR201702002008738 Date of Approval: 30/01/2017
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Teaching Cochrane trial
Official scientific title Effectiveness of teaching medical students on Cochrane activities: a randomized controlled trial
Brief summary describing the background and objectives of the trial The medical school has a key role in training medical professionals to the highest internationally accepted standards in quality research activities. In keeping with these standards its teaching staff recognizes the significance of ensuring that its students are furnished with the knowledge and skills of Cochrane activities which will ultimately help them in evidence-based clinical decision making. This is the first such study evaluating whether teaching medical students on Cochrane activities improves the knowledge and competence of medical students to Cochrane activities compared to conventional teaching. Objectives: To assess whether teaching medical students on Cochrane activities improves the knowledge and competence of medical students to Cochrane activities compared to conventional teaching.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Research activity
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Education /Training
Anticipated trial start date 30/01/2017
Actual trial start date
Anticipated date of last follow up 15/02/2017
Actual Last follow-up date
Anticipated target sample size (number of participants) 200
Actual target sample size (number of participants)
Recruitment status 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
Randomised Stratified allocation where factors such as previous treatment are used in the stratification Allocation was determined by the holder of the sequence who is situated off site Masking/blinding used Outcome Assessors
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Teaching Cochrane activities once 2 hours We randomly allocated the students to receive Cochrane activities lecture or non cochrane teaching 50
Control Group Conventional Obstetrics and Gynecology lecture group once 2 hours We randomly allocated the students to receive conventional Obstetrics and Gynecology lecture. The teaching sessions lasted approximately two hours. The domains were measured by an assessor who was blinded to the allocated teaching interventions. Analysis was by intention-to treat. Baseline characteristics of the students enrolled in the two groups were compare 150
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
consenting students Those in obstetrics and gynecology class Non-consenting students Those already graduated 18 Year(s) 65 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 27/01/2017 NAUTH eTHICS cOMMITTEE
Ethics Committee Address
Street address City Postal code Country
NAUTHEC,, ONITSHA ONITSHA ROAD HERE NNEWI 435001 Nigeria
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Student's knowledge Pre and post lecture.
Secondary Outcome Student's competence Pre and post teaching
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Madonna University, Elele portharcourt road, box 48 pH. Portharcourt 435001 Nigeria
Nnamdi Azikiwe University, nnewi Campus no 97 enugu onitsha road, nnewi nnewi 435001 Nigeria
FUNDING SOURCES
Name of source Street address City Postal code Country
DR GEORGE ELEJE no 97 enugu onitsha road, nnewi nnewi 435001 Nigeria
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor DR GEORGE ELEJE no 97 enugu onitsha road, nnewi nnewi 435001 Nigeria Charities/Societies/Foundation
Secondary Sponsor PROF JOSEPH IKECHEBELU 49 IKEMBA DRIVE nnewi 435001 Nigeria Hospital
COLLABORATORS
Name Street address City Postal code Country
PROF JOSEPH IKECHEBELU 49 IKEMBA DRIVE nnewi 435001 Nigeria
DR RICHARD EGEONU 97 ENUGU ONITSHA ROAD nnewi 435001 Nigeria
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator GEORGE ELEJE georgel21@yahoo.com +2348068117444 no 97 enugu onitsha road
City Postal code Country Position/Affiliation
nnewi 435001 Nigeria LECTURER/CONSULTANT
Role Name Email Phone Street address
Public Enquiries RICHARD EGEONU richard.obinwanne@yahoo.com +2348068907209 no 97 enugu onitsha road
City Postal code Country Position/Affiliation
nnewi 435001 Nigeria SENIOR REGISTRAR
Role Name Email Phone Street address
Scientific Enquiries JOSEPH IKECHEBELU ji.ikechebelu@unizik.edu.ng +2348034044189 no 97 enugu onitsha road
City Postal code Country Position/Affiliation
nnewi 435001 Nigeria Professor/Senior consultant
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
URL Results Available Results Summary Result Posting Date First Journal Publication Date
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