A Multicenter, Parallel-group, Randomized Controlled Trial to Assess the Efficacy of Two Different Educational Approaches on Intermittent Catheter-related Acceptance and Patient-Reported Outcome Measures (PROMs): RElax & feeL at EASE (RELEASE)
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 64
- 主要终点
- Change in Intermittent Catheterization Acceptance (I-CAT) Score
研究概览
简要总结
This multicenter, parallel-group, randomized controlled trial (RELEASE) aims to evaluate the efficacy of two educational approaches on acceptance and adherence to intermittent catheterization (IC) among adult male patients. Participants requiring IC training will be randomized to either an enhanced educational intervention (informational booklet, video tutorial, and standard training) or standard clinical practice training alone. The primary outcome is the change in Intermittent Catheterization Acceptance Test (I-CAT) scores over three months. Secondary outcomes include adherence (I-CAS), urinary symptoms (USQNB-IC), patient autonomy, satisfaction with assistive technology (QUEST), and functional abilities. The study seeks to identify the most effective educational strategy to improve psychological acceptance, promote adherence, and reduce complications in patients performing IC, ultimately supporting patient-centered care and health system efficiency.
详细描述
This multicenter, randomized controlled trial (RELEASE study) investigates the effectiveness of two different educational approaches to improve acceptance and adherence to intermittent catheterization (IC) among adult male patients who require IC training. Participants will be randomly assigned to one of two groups: an intervention group receiving an enhanced educational program (including an informational booklet, video tutorial, and standard clinical training) and a control group receiving only standard clinical practice training.
The study will enroll adult male patients with an indication for self-managed intermittent catheterization and who are physically and cognitively able to learn IC techniques. The primary outcome measure is the change in Intermittent Catheterization Acceptance Test (I-CAT) scores at three months (T2) compared to baseline (T0).
Secondary outcomes include adherence measured using the Intermittent Catheterization Adherence Scale (I-CAS), urinary symptoms evaluated with the USQNB-IC, patient autonomy, satisfaction with assistive technology (QUEST 2.0), and overall functional abilities. Additional data such as socio-demographic characteristics and medical history will also be collected.
The trial seeks to provide evidence on the most effective educational strategy to support psychological acceptance and sustained adherence to IC, reduce complications, and promote greater patient autonomy. By addressing educational gaps, the study aims to enhance patient-centered care and optimize resource use within the healthcare system.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Male patients aged 18 years or older.
- •Diagnosed with neurogenic bladder requiring self-managed intermittent catheterization (IC).
- •Currently performing IC or newly prescribed IC.
- •Able to provide informed consent and understand study instructions.
- •Able to understand and complete study questionnaires in Italian.
排除标准
- •Presence of cognitive impairment limiting ability to understand or perform IC independently.
- •Severe upper limb motor deficits preventing independent catheterization.
- •Active urinary tract infection at baseline.
- •Participation in another interventional study that could interfere with outcomes.
- •Any condition that, in the opinion of the investigators, makes the patient unsuitable for study participation.
结局指标
主要结局
Change in Intermittent Catheterization Acceptance (I-CAT) Score
时间窗: Baseline (T0) to 3 months (T2)
Change in psychological acceptance of intermittent catheterization measured using the Intermittent Catheterization Acceptance Test (I-CAT). The I-CAT assesses acceptance attitudes toward IC, including psychological readiness and emotional adaptation. Higher scores indicate greater acceptance.
次要结局
- Overall Functional Abilities(Baseline (T0) to 3 months (T2))
- Adherence to Intermittent Catheterization (I-CAS Score)(Baseline (T0) to 3 months (T2))
- Satisfaction with Assistive Technology (QUEST 2.0)(3 months (T2))
- Urinary Symptoms Severity (USQNB-IC)(Baseline (T0) to 3 months (T2))
- Patient Autonomy Level(Baseline (T0) to 3 months (T2))
研究者
Stefania Musco
MD
Careggi Hospital