Effectiveness of Visual Storytelling Intervention on Antibiotic Adherence in UTI Patients in Pakistan: a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 358
- 试验地点
- 1
- 主要终点
- Antibiotic adherence
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Double (Care Provider, Outcomes Assessor)
盲法说明
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.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
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.
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.
干预措施: Visual Storytelling Intervention for Antibiotic Adherence (Behavioral)
结局指标
主要结局
Antibiotic adherence
时间窗: 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).
次要结局
- UTI Recurrence(UTI recurrence will be assessed at 3 months, and 6 months following the initial antibiotic treatment.)
- 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.)
- 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.)
研究者
Iltaf Hussain
Principal Investigator
Xi'an Jiaotong University