- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05399797
Management of Acute Uncomplicated UTIs in Adults by Community Pharmacists ([UTI])
May 26, 2022 updated by: Abdulhafiz Taofiq Tanimola, University of Ibadan
Impact of Online Counselling Training For Pharmacists on The Management of Acute Uncomplicated Urinary Tract Infections in Adults; A Double-blind Randomized Controlled Trial
This study is to be conducted in community pharmacies.
It involves the use of trained mystery patients to evaluate community pharmacists at baseline and post intervention.
The pharmacists will be divided into control and intervention groups using computer generated codes.
Those in the intervention group will receive an online training by clinical pharmacists.
The training will employ the use of didactic teaching and the use of case studies and simulations covering the diagnosis and management of acute uncomplicated urinary tract infections in adults.
Post intervention, mystery patients will revisit the community pharmacists in the control and intervention groups for re-assessment.
Study Overview
Status
Recruiting
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
80
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Abdulhafiz T Taofiq, B.Pharm.
- Phone Number: +2347063798732
- Email: taofiq32@gmail.com
Study Contact Backup
- Name: Segun J Showande, Ph.D.
- Phone Number: +2348027887608
- Email: pharmsegg@yahoo.com
Study Locations
-
-
Oyo
-
Ibadan, Oyo, Nigeria, 200284
- Recruiting
- University of Ibadan
-
Contact:
- Taofiq T Abdulhafiz, B.Pharm
- Phone Number: +2347063798732
- Email: taofiq32@gmail.com
-
Contact:
- Segun J Showande, Ph.D.
- Phone Number: +2348027887608
- Email: sj.showande@gmail.com
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- The superintendent pharmacist, or the pharmacist manager or any other post National Youth Service Corps pharmacist
Exclusion Criteria:
- Interns, and pharmacists undergoing the mandatory National Youth Service Corps program.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Pharmacists in the intervention group
The pharmacist will be given an online educational training on management of acute uncomplicated urinary tract infections
|
Pharmacists in the intervention group will given detailed online educational training on how to recognize and manage acute uncomplicated urinary tract infections in adults.
|
|
No Intervention: Pharmacists in the control group
pharmacists in this group will not be trained, until after the completion of the study.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Questioning skill score
Time Frame: Through the study completion (an average of 6 months)
|
Expert Panels' Relevant Questions - Through 80% consensus the expert panel picked 50 relevant questions.
The minimum score is "0" and the maximum score is "50".
The higher the score the better the questioning skill.
|
Through the study completion (an average of 6 months)
|
|
Correct diagnosis of Acute Uncomplicated Urinary Tract Infection
Time Frame: Through the study completion (an average of 6 months)
|
using the Infectious Disease Society of America treatment guideline, the pharmacists should be able to reach a diagnosis of Acute Uncomplicated Urinary Tract Infection.
Appropriate diagnosis will be classified as "Correct diagnosis" and inappropriate diagnosis will be classified as "Incorrect diagnosis".
Proportion will be used to describe the number of community pharmacists who got the diagnosis Correct and Incorrect.
|
Through the study completion (an average of 6 months)
|
|
Appropriate management of urinary tract infection
Time Frame: Through the study completion (an average of 6 months)
|
Infectious Disease Society of America treatment guideline
|
Through the study completion (an average of 6 months)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Chair: Segun J Showande, Ph.D., University of Ibadan
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
March 21, 2022
Primary Completion (Anticipated)
September 1, 2022
Study Completion (Anticipated)
November 1, 2022
Study Registration Dates
First Submitted
May 7, 2022
First Submitted That Met QC Criteria
May 26, 2022
First Posted (Actual)
June 1, 2022
Study Record Updates
Last Update Posted (Actual)
June 1, 2022
Last Update Submitted That Met QC Criteria
May 26, 2022
Last Verified
May 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- taofiqclinical
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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