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.: PACTR202208586601902 Date of Approval: 19/08/2022
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Intervention for improving pharmacist-led patient counselling on Non steroidal anti-inflammatory drugs(NSAIDs) use in a community setting- a randomized control trial
Official scientific title Improving pharmacist-led patient counselling and assessment of risk factors for non-steroidal anti-inflammatory drugs(NSAIDs) in a community pharmacy - A double blind randomized control trial
Brief summary describing the background and objectives of the trial NSAIDs are utilized globally for their anti-inflammatory, antipyretic, and analgesic properties but are among the most extensively used and abused drugs. This could be partly due to their availability as over-the-counter drugs and the public's lack of understanding of the risks linked with their use. Patients have a knowledge gap on the use of their medications. Community pharmacists are ideally positioned to close it. This trial is to evaluate the impact of pharmacists' training on screening for risk factors for NSAID use and the quality of counseling provided by community pharmacists.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Counselling ability of pharmacists and assessment of the risk for the use of NSAIDs,Musculoskeletal Diseases
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Education /Training
Anticipated trial start date 01/05/2022
Actual trial start date 16/05/2022
Anticipated date of last follow up 31/10/2022
Actual Last follow-up date 31/10/2022
Anticipated target sample size (number of participants) 132
Actual target sample size (number of participants) 125
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
Parallel: different groups receive different interventions at same time during study Randomised Simple randomization using a randomization table created by a computer software program Allocation was determined by the holder of the sequence who is situated off site Masking/blinding used Outcome Assessors,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Intervention group Self-paced training modules Two weeks Educational training for community pharmacists covering two special areas in the use of non-steroidal anti-inflammatory drugs(NSAIDs): 1. Assessment of the risk factors prior to the use of non-steroidal anti-inflammatory drugs(NSAIDs) 2. Appropriate and adequate counseling on the use of non-steroidal anti-inflammatory drugs(NSAIDs). 63
Control Group Control group No educational training Two weeks No educational intervention will be provided. 62 Dose Comparison
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Superintendent pharmacists Pharmacist managers Post-National Youth Service Corps Pharmacist Intern Pharmacists National Youth Service Corps Pharmacists Non-Pharmacists Adult: 19 Year-44 Year,Aged: 65+ Year(s),Middle Aged: 45 Year(s)-64 Year(s) 21 Year(s) 80 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 04/02/2022 Institute for Advanced Medical Research and Training
Ethics Committee Address
Street address City Postal code Country
University College Hospital, Agodi, Ibadan, Oyo State. Ibadan 200285 Nigeria
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome 1. Mean counselling ability. 2. Mean risk factor screening score. 0, 3 months
Secondary Outcome 1. Mean questioning skill 0, 3 months
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
University of Ibadan Oduduwa road Ibadan 200005 Nigeria
FUNDING SOURCES
Name of source Street address City Postal code Country
Akinbode Tolulope Eunice University of Ibadan, Oduduwa road, Ibadan Ibadan 200005 Nigeria
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Akinbode Tolulope Eunice University of Ibadan, Oduduwa road, Ibadan, Oyo State, Nigeria Ibadan 200005 Nigeria Individual
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Tolulope Akinbode blejom13@gmail.com +2348064051748 Federal College of Education, Abeokuta Ibadan Express Way, Abeokuta, Ogun State.
City Postal code Country Position/Affiliation
Abeokuta 200005 Nigeria student University of Ibadan
Role Name Email Phone Street address
Scientific Enquiries Segun Showande sj.showande@ui.edu.ng +2348027887608 University of Ibadan
City Postal code Country Position/Affiliation
Ibadan 200005 Nigeria Acting head of department University of Ibadan
Role Name Email Phone Street address
Public Enquiries Taofiq Abdulhafeez taofiq32@gmail.com +2347063798732 University of Ibadan
City Postal code Country Position/Affiliation
Ibadan 200005 Nigeria Student University of Ibadan
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes The summary results on Individual Participant Data will be included on this site at the completion of the trial. Clinical Study Report 1 year on completion of study Data will be shared on reasonable request. However, the results of the trial will be upload on the site within 1 year of completion of the trial.
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