Urinary Tract Infections[UTI]NCT05399797
Management of Acute Uncomplicated UTIs in Adults by Community Pharmacists
A study testing Educational training in people with Urinary Tract Infections and Urinary Tract Infection Lower Acute, run by University of Ibadan at 1 site in Nigeria.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Urinary Tract Infections, Urinary Tract Infection Lower Acute
- What is being tested?
- Educational training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteNigeria
- Study dates
- 21 Mar 2022to Nov 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- The superintendent pharmacist, or the pharmacist manager or any other post National Youth Service Corps pharmacist
Who cannot join
- Interns, and pharmacists undergoing the mandatory National Youth Service Corps program.
Trial locations and contacts
1 site in 1 country.
Nigeria1 site, 1 recruiting
- Recruiting
University of Ibadan
Ibadan, Oyo State, 200284
Taofiq T Abdulhafiz, B.Pharm, +2347063798732, taofiq32@gmail.com
Segun J Showande, Ph.D., +2348027887608, sj.showande@gmail.com
About this study
Official title: 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.
- Being tested
- Educational training
- Keywords
- Urinary Tract Infections, Pharmacist, Mystery Patient
- Medical subject headings
- Urinary Tract Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Educational trainingOther
Pharmacists in the intervention group will given detailed online educational training on how to recognize and manage acute uncomplicated urinary tract infections in adults.
| Study group | Role | What they receive |
|---|---|---|
| Pharmacists in the intervention group | Experimental | The pharmacist will be given an online educational training on management of acute uncomplicated urinary tract infections Receives: Other: Educational training |
| Pharmacists in the control group | No intervention | pharmacists in this group will not be trained, until after the completion of the study. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Questioning skill score
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.
Measured: Through the study completion (an average of 6 months)
Correct diagnosis of Acute Uncomplicated Urinary Tract Infection
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.
Measured: Through the study completion (an average of 6 months)
Appropriate management of urinary tract infection
Infectious Disease Society of America treatment guideline
Measured: Through the study completion (an average of 6 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2022
- Study start21 Mar 2022
- Primary completionSep 2022 (estimated)
- Study completionNov 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Urinary Tract InfectionsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The pharmacists in the interventional group will receive educational training after baseline assessment while those in the control group will receive the same training at the end of the study
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Ibadan
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Abdulhafiz Taofiq Tanimola, University of Ibadan
- Investigators
- Segun J Showande, Ph.D., Study chair, University of Ibadan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05399797
- Sponsor's protocol ID
- taofiqclinical
- Acronym
- [UTI]
- Status last verified
- May 2022
- First submitted
- 7 May 2022
- Last updated
- 1 Jun 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Online Counselling Training For Pharmacists on The Management of Acute Uncomplicated Urinary Tract Infections in Adults; A Double-blind Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05399797
- Acronym / sponsor ID
- [UTI] / taofiqclinical
- Keywords
- Urinary Tract Infections, Pharmacist, Mystery Patient
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- University of IbadanUniversity, hospital or other
- Study start
- 21 Mar 2022 (actual)
- Primary completion
- Sep 2022 (estimated)
- Study completion
- Nov 2022 (estimated)
- First posted
- 1 Jun 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- The pharmacists in the interventional group will receive educational training after baseline assessment while those in the control group will receive the same training at the end of the study
| Arm | Type | Receives |
|---|---|---|
| Pharmacists in the intervention group | Experimental | Other: Educational trainingThe pharmacist will be given an online educational training on management of acute uncomplicated urinary tract infections |
| Pharmacists in the control group | No intervention | –pharmacists in this group will not be trained, until after the completion of the study. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- The superintendent pharmacist, or the pharmacist manager or any other post National Youth Service Corps pharmacist
Key exclusion criteria (1 listed)
- Interns, and pharmacists undergoing the mandatory National Youth Service Corps program.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Educational trainingPharmacists in the intervention group will given detailed online educational training on how to recognize and manage acute uncomplicated urinary tract infections in adults. | Other | Pharmacists in the intervention group |
Primary outcome
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.
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.
Appropriate management of urinary tract infection
Time frame: Through the study completion (an average of 6 months)
Infectious Disease Society of America treatment guideline
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jun 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Segun J Showande, Ph.D. study chair
University of Ibadan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Educational training in people with Urinary Tract Infections and Urinary Tract Infection Lower Acute, run by University of Ibadan at 1 site in Nigeria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 1 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Nigeria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Abdulhafiz T Taofiq, B.Pharm. (+2347063798732, taofiq32@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Questioning skill score (time frame: Through the study completion (an average of 6 months)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jun 2022.