- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06885658
Effectiveness of Visual Storytelling Intervention on Antibiotic Adherence in UTI Patients (ABR UTI)
Effectiveness of Visual Storytelling Intervention on Antibiotic Adherence in UTI Patients in Pakistan: a Randomized Controlled Trial
Study Overview
Status
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Khyber Pakhtunkhwa
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Peshawar, Khyber Pakhtunkhwa, Pakistan
- Tertiary care hospitals (n = 6)
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Adults aged 18 years or older.
- Physician-confirmed diagnosis of uncomplicated urinary tract infection (UTI).
- Prescribed oral antibiotics (tablet/capsule) for UTI treatment.
- Willingness to participate in the study and provide informed consent.
- Ability to complete follow-up assessments and adhere to the study protocol.
Exclusion Criteria:
- Diagnosed with complicated UTI (e.g., pyelonephritis, sepsis, or structural abnormalities).
- Multiple comorbidities that require polypharmacy.
- Cognitive impairment or mental disorders that would interfere with study participation.
- Pregnant or breastfeeding women.
- Participation in another clinical trial that could interfere with this study.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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No Intervention: Control Group: Standard Care for Antibiotic Adherence
The control group will receive the usual standard care for antibiotic adherence, which typically includes verbal or written instructions provided by the healthcare provider about the correct usage of prescribed antibiotics for treating urinary tract infections (UTI).
This group will not receive any additional interventions, such as the visual storytelling intervention.
The standard care aims to represent the typical approach to UTI treatment, allowing for a comparison of the effectiveness of the visual storytelling intervention against routine practice in improving antibiotic adherence.
Participants in this group will also complete the same baseline and follow-up assessments related to knowledge and attitudes about antibiotics and adherence.
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Experimental: Intervention Arm: Visual Storytelling using stickers
In this arm, participants will receive a visual storytelling intervention designed to improve antibiotic adherence.
The intervention involves a stickers (affixed to the antibiotic packages) containing simple, visually appealing illustrations that explain how antibiotics work and the consequences of not completing the full course.
The story contrasts the positive outcomes of adhering to the treatment with the risks of non-adherence, including the development of antibiotic resistance.
Key messages will highlight the importance of completing the prescribed antibiotic course.
The intervention is intended to engage patients emotionally and cognitively, enhancing their understanding of antibiotic use and encouraging adherence to the prescribed treatment regimen.
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The intervention involves the use of a visual storytelling approach designed to improve antibiotic adherence in patients diagnosed with urinary tract infections (UTIs).
The intervention consists of a sticker featuring simple, visually appealing illustrations and a narrative highlighting the importance of completing the full course of prescribed antibiotics.
The story contrasts the positive outcomes of adhering to the treatment with the negative consequences of stopping early, such as increased bacterial resistance.
Key messages are reinforced through bold text and visual cues.
This intervention aims to engage patients emotionally and cognitively, promoting behavior change by making the concept of antibiotic adherence more relatable and memorable.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Antibiotic adherence
Time Frame: Based on the antibiotic treatment course (3-7 days)
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The primary outcome measure of this study is antibiotic adherence, which will be assessed by tracking the number of prescribed antibiotic pills taken by the participants at the end of their treatment course (typically 3-7 days). Adherence will be calculated in two ways: Proportional Adherence: The percentage of the prescribed pills that the patient takes will be calculated, expressed as a proportion (number of pills taken/total prescribed). Categorical Adherence: Patients will be categorized as "adhered" (if they took ≥90% of the prescribed antibiotics) or "not adhered" (if they took <90% of the prescribed antibiotics). |
Based on the antibiotic treatment course (3-7 days)
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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UTI Recurrence
Time Frame: UTI recurrence will be assessed at 3 months, and 6 months following the initial antibiotic treatment.
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This outcome will assess whether a participant experiences a recurrence of a urinary tract infection (UTI) after completing the prescribed course of antibiotics.
Recurrence will be confirmed by a physician based on clinical evaluation and/or laboratory tests.
A binary response (Yes/No) will be recorded based on physician confirmation of UTI recurrence.
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UTI recurrence will be assessed at 3 months, and 6 months following the initial antibiotic treatment.
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Knowledge
Time Frame: Knowledge will be assessed at baseline (before the intervention) and at first follow up (3-7 days) 3 months, and 6 months follow-up after the intervention.
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Knowledge Measurement: A 10-item true/false questionnaire will assess the patient's understanding of antibiotic use, antibiotic resistance, and the importance of completing the full antibiotic course.
This includes questions like understanding the consequences of not completing antibiotic treatment or misusing antibiotics.
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Knowledge will be assessed at baseline (before the intervention) and at first follow up (3-7 days) 3 months, and 6 months follow-up after the intervention.
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Attitude
Time Frame: Attitude will be assessed at baseline (before the intervention) and at first follow up (3-7 days) 3 months, and 6 months follow-up after the intervention.
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Attitude Measurement: A 5-item Likert scale will assess the patient's attitude towards antibiotics and adherence.
Statements such as "Completing the full course of antibiotics is very important" and "I trust the advice given by my doctor regarding antibiotics" will be used to gauge attitude.
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Attitude will be assessed at baseline (before the intervention) and at first follow up (3-7 days) 3 months, and 6 months follow-up after the intervention.
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Collaborators and Investigators
Sponsor
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- BZU-FOPDPP-2466
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Given the sensitive nature of the data, particularly related to participants' health and personal information, ensuring privacy and confidentiality is of paramount importance. Sharing IPD may risk the unintended disclosure of personal identifiers.
The study has been approved by an institutional ethics board, and the informed consent provided by participants specified the use of their data strictly for the purposes outlined in the study. Sharing IPD outside the approved scope could violate ethical guidelines and regulatory frameworks.
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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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