Optimization of the STAR Intervention on Self-care Symptom Management in Patients With Heart Failure
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- UMC Utrecht
- 入组人数
- 320
- 主要终点
- Interference of bothersome symptoms
研究概览
简要总结
The aim of this study is optimize the STAR (SympTom mAnagement self-caRe) intervention to support patients with HF in staying healthy, and particularly in self-monitoring and managing symptoms. The STAR intervention includes promising components aiming at improving patient outcomes in terms of interference of bothersome symptoms, self-care, quality of life (QoL) and healthcare utilization.
In this study, the intervention components are tested in an optimization trial in 320 patients with HF from 8 HF clinics in the Netherlands. This study will result in an optimized STAR intervention, composed of the best components, that is effective, scalable, and efficient to improve patient outcomes and can be used in HF clinics.
详细描述
According to the Multiphase Optimization StraTegy (MOST), in this optimization trial, the investigators aim to evaluate and optimize the components of the STAR intervention prior to evaluation in an RCT. The STAR intervention consists of different components (modules): one basic module and three key modules. The basic module consists of information about HF and preparatory exercises; the key modules consist of training to improve symptom awareness, symptom management counseling, and symptom management option experiments. Following MOST, the investigators developed different intensity version of each key module: a low intensity version and a high intensity version. The low intensity version is more basic compared to the high intensity version. The low and high intensity versions differ in the mode of feedback from the HF nurses (written vs verbal) or intensity of exercises or feedback (e.g. one week vs two weeks); the content remains the same. These two versions allow the investigators to evaluate which mode and dose works best for each module and are tested in this optimization trial using factorial experiments. The most contributing versions of modules are then integrated into the STAR intervention.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Supportive Care
- 盲法
- None
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
- •Diagnosed with HF (irrespective of ejection fraction) and symptomatic NYHA class II or III.
- •18 years or older.
- •Willing and able to provide written informed consent.
- •Life expectancy >6 months.
- •Optimal medical HF treatment following ESC HF guidelines (i.e. 'patients with stable HF').
排除标准
- •Participants living in a care facility (e.g. nursing home, revalidation center).
- •Language barrier preventing sufficient understanding and communication in Dutch.
- •Participants who are hospitalized during inclusion.
结局指标
主要结局
Interference of bothersome symptoms
时间窗: From Baseline (T0) to the end of the last module (T4) at the following time points: Baseline (T0), week 1 (T1), week 2-3 (T2), week 4 (T3), week 6 (T4)
For interference of bothersome symptoms three domains of the Kansas City Cardiomyopathy Questionnaire will be assessed: symptom, physical function and symptom stability. Scores are standardized on a scale from 0 to 100, with higher scores representing fewer symptoms.
次要结局
- Self-care(Measured at baseline and week 6 (T4))
- HRQoL(Measured at baseline and week 6 (T4))
- Healthcare utilization(Measured at baseline and week 6 (T4))
- Healthcare utilization 2(Measured at baseline and week 6 (T4))
- Healthcare utilization 3(Measured at baseline and week 6 (T4))