Patient With Uncomplicated UTI, Uncomplicated Urinary Tract Infection
Conditions
Keywords
Visual storytelling, Antibiotic Adherence, UTI recurrence
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.
Interventions
BEHAVIORALVisual Storytelling Intervention for Antibiotic Adherence
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.
Sponsors
Xi'an Jiaotong University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
DOUBLE (Caregiver, Outcomes Assessor)
Masking description
In this study, the participants and site staff delivering the intervention will not be masked, due to the nature of the behavioral intervention (visual storytelling sticker), which participants will be actively engaged with. However, the physician who diagnoses the UTI and confirms UTI recurrence will be blinded to the intervention allocation to avoid bias in outcome assessment. Additionally, the data analysts (outcome assessor) will be blinded to group assignments. The dataset will be labeled neutrally (e.g., "Group A" and "Group B") to ensure unbiased analysis of the primary and secondary outcomes.
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 sticker affixed on the antibiotic packaging 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
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
Pakistan
Outcome results
None listed