Effectiveness of Visual Storytelling Intervention on Antibiotic Adherence in UTI Patients

NCT ID: NCT06885658

Last Updated: 2025-12-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

358 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-06-03

Study Completion Date

2025-12-17

Brief Summary

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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

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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.

Conditions

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Uncomplicated Urinary Tract Infection Patient With Uncomplicated UTI

Keywords

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Visual storytelling Antibiotic Adherence UTI recurrence

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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
Primary Study Purpose

OTHER

Blinding Strategy

DOUBLE

Caregivers Outcome Assessors
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.

Study Groups

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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.

Group Type EXPERIMENTAL

Visual Storytelling Intervention for Antibiotic Adherence

Intervention Type BEHAVIORAL

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.

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Visual 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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Xi'an Jiaotong University

OTHER

Sponsor Role lead

Responsible Party

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Iltaf Hussain

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Tertiary care hospitals (n = 6)

Peshawar, Khyber Pakhtunkhwa, Pakistan

Site Status

Countries

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Pakistan

References

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Hussain I, Rasool MF, Ullah J, Khan I, Kadirhaz M, Xu M, Tang C, Dong Y, Zhao W, Khan FU, Chang J, Fang Y. Effectiveness of nudge-based visual storytelling in antibiotic adherence in uncomplicated urinary tract infection in Pakistan: protocol for a randomized controlled trial. Trials. 2025 Dec 17. doi: 10.1186/s13063-025-09328-1. Online ahead of print.

Reference Type DERIVED
PMID: 41408333 (View on PubMed)

Other Identifiers

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BZU-FOPDPP-2466

Identifier Type: -

Identifier Source: org_study_id