Clinical trial NCT06885658: Effectiveness of Visual Storytelling Intervention on Antibiotic Adherence in UTI Patients
Official title: Effectiveness of Visual Storytelling Intervention on Antibiotic Adherence in UTI Patients: Randomized Controlled Trial Protocol
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Uncomplicated Urinary Tract Infection
Patient with Uncomplicated UTI
Keywords: Visual storytelling
Antibiotic Adherence
UTI recurrence
Lead sponsor: Xi'an Jiaotong University
Sponsor class: OTHER
First posted: 2025-03-20
Enrollment: 410
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This study uses a parallel two-arm randomized controlled trial (RCT) design. Participants will be randomly assigned in a 1:1 ratio to either:

Intervention group: Receives a visual storytelling intervention designed to improve antibiotic adherence in patients with urinary tract infections (UTIs).

Control group: Receives standard care, which includes routine verbal or written instructions about antibiotic use.

The intervention involves the delivery of a pamphlet containing visual stories that emphasize the importance of completing the full antibiotic course and the consequences of non-adherence, including antibiotic resistance. The study aims to compare the effectiveness of this intervention with standard care in improving adherence to prescribed antibiotics
Primary purpose: TREATMENT

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 pamphlet 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 pamphlet 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Antibiotic adherence
timeFrame: 3-7 days, based on the antibiotic treatment course
Secondary outcomes:
measure: UTI Recurrence
timeFrame: UTI recurrence will be assessed at 3 months, and 6 months following the initial antibiotic treatment.
measure: Knowledge
timeFrame: 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.
measure: Attitude
timeFrame: 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.
Other outcomes:
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