Effectiveness of Visual Storytelling Intervention on Antibiotic Adherence in UTI Patients

Not Applicable

Recruiting

• Conditions: Uncomplicated Urinary Tract Infection; Patient With Uncomplicated UTI

• Registration Number: NCT06885658
• Lead Sponsor: Xi'an Jiaotong University

Brief Summary

This study aims to evaluate the effectiveness of a visual storytelling intervention in improving antibiotic adherence among adults with urinary tract infections (UTIs). Participants will be randomly assigned to either the intervention group, where they will receive a visual sticker on their antibiotic packaing, explaining the importance of completing their antibiotic course, or the control group, which will receive routine care. The study will measure how well participants follow their prescribed antibiotic regimens and assess their knowledge and attitudes toward antibiotic use. The goal is to determine if visual storytelling can enhance adherence, reduce antibiotic resistance, and improve health outcomes.

Detailed Description

This randomized controlled trial (RCT) will assess the impact of a visual storytelling intervention on antibiotic adherence among adults diagnosed with uncomplicated urinary tract infections (UTIs). The intervention involves a visually engaging sticker that educates patients on the importance of completing their prescribed antibiotic course and the consequences of non-adherence, such as antibiotic resistance. Participants will be randomly assigned to either the intervention or control group, with the control group receiving standard care (e.g., verbal or written instructions). The primary outcome is adherence to the antibiotic regimen, measured by pill counts. Secondary outcomes include UTI recurrence, knowledge about antibiotic use, and attitudes toward antibiotic treatment. Data will be collected at baseline, immediately after the intervention, and at follow-up visits over 1, 3, and 6 months. This study seeks to determine if visual storytelling can improve antibiotic adherence and help combat antibiotic resistance.

Study Timeline

• Study First Submitted: 2025-02-28
• Study First Submitted QC: 2025-03-13
• Study First Posted: 2025-03-20
• Study Start: 2025-08-01
• Status Verified: 2025-09
• Last Update Submitted: 2025-09-22
• Last Update Posted: 2025-09-26
• Primary Completion: 2025-10
• Study Completion: 2026-01-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 358

Inclusion Criteria

1. Adults aged 18 years or older.
2. Physician-confirmed diagnosis of uncomplicated urinary tract infection (UTI).
3. Prescribed oral antibiotics (tablet/capsule) for UTI treatment.
4. Willingness to participate in the study and provide informed consent.
5. Ability to complete follow-up assessments and adhere to the study protocol.

Exclusion Criteria

1. Diagnosed with complicated UTI (e.g., pyelonephritis, sepsis, or structural abnormalities).
2. Multiple comorbidities that require polypharmacy.
3. Cognitive impairment or mental disorders that would interfere with study participation.
4. Pregnant or breastfeeding women.
5. Participation in another clinical trial that could interfere with this study.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Antibiotic adherence	Based on the antibiotic treatment course (3-7 days)	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).

Secondary Outcome Measures

Name	Time	Method
UTI Recurrence	UTI recurrence will be assessed at 3 months, and 6 months following the initial antibiotic treatment.	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.
Knowledge	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.	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.
Attitude	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.	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.

Trial Locations

Locations (1)

Tertiary care hospitals (n = 6); 🇵🇰 Peshawar, Khyber Pakhtunkhwa, Pakistan