Optimization of STAR

Официальное название

Optimization of the STAR Intervention on Self-care Symptom Management in Patients With Heart Failure

Обзор

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.

Подробное описание

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.

Вмешательства

• Другое STAR condition 1
  * Basic module: HF information and doing symptom awareness exercises. * Low version Module 1: Symptom awareness exercises 2 times in 1 week, and written feedback HF nurse * Low version Module 2: Coaching in symptom management response and choose symptom response option to experiment with. Written feedback from HF nurse * Low version Module 3: Instruction and doing symptom management experiments for 2 weeks + keep logs; Written feedback HF nurse
• Другое STAR condition 2
  Basic module: aims to improve the participant's illness perceptions and standardize HF knowledge at the start of the intervention and doing exercises.- Low version Module 1: Symptom awareness exercises 2 times in 1 week, and written feedback HF nurse - Low version Module 2: Coaching in symptom management response and choose symptom response option to experiment with. Written feedback from HF nurse - High version Module 3: Instruction and doing symptom management experiments for 2 weeks + keep lo
• Другое STAR condition 3
  Basic module: aims to improve the participant's illness perceptions and standardize HF knowledge at the start of the intervention and doing exercises.- Low version Module 1: Symptom awareness exercises 2 times in 1 week, and written feedback HF nurse - High version Module 2: Coaching in symptom management response and choose symptom response option to experiment with. Verbal feedback from HF nurse - High version Module 3: Instruction and doing symptom management experiments for 2 weeks + keep lo
• Другое STAR condition 4
  Basic module: aims to improve the participant's illness perceptions and standardize HF knowledge at the start of the intervention and doing exercises.- Low version Module 1: Symptom awareness exercises 2 times in 1 week, and written feedback HF nurse - High version Module 2: Coaching in symptom management response and choose symptom response option to experiment with. Verbal feedback from HF nurse - Low version Module 3: Instruction and doing symptom management experiments for 2 weeks + keep log
• Другое STAR condition 5
  Basic module: aims to improve the participant's illness perceptions and standardize HF knowledge at the start of the intervention and doing exercises.- High version Module 1: Symptom awareness exercises 6 times in 2 weeks, and verbal feedback HF nurse - Low version Module 2: Coaching in symptom management response and choose symptom response option to experiment with. Written feedback from HF nurse - Low version Module 3: Instruction and doing symptom management experiments for 2 weeks + keep lo
• Другое STAR condition 6
  Basic module: aims to improve the participant's illness perceptions and standardize HF knowledge at the start of the intervention and doing exercises.- High version Module 1: Symptom awareness exercises 6 times in 2 weeks, and verbal feedback HF nurse - Low version Module 2: Coaching in symptom management response and choose symptom response option to experiment with. Written feedback from HF nurse - High version Module 3: Instruction and doing symptom management experiments for 2 weeks + keep l
• Другое STAR condition 7
  Basic module: aims to improve the participant's illness perceptions and standardize HF knowledge at the start of the intervention and doing exercises.- High version Module 1: Symptom awareness exercises 6 times in 2 weeks, and verbal feedback HF nurse - High version Module 2: Coaching in symptom management response and choose symptom response option to experiment with. Verbal feedback from HF nurse - Low version Module 3: Instruction and doing symptom management experiments for 2 weeks + keep lo
• Другое STAR condition 8
  Basic module: aims to improve the participant's illness perceptions and standardize HF knowledge at the start of the intervention and doing exercises.- High version Module 1: Symptom awareness exercises 6 times in 2 weeks, and verbal feedback HF nurse - High version Module 2: Coaching in symptom management response and choose symptom response option to experiment with. Verbal feedback from HF nurse - High version Module 3: Instruction and doing symptom management experiments for 2 weeks + keep l

Первичные конечные точки

• Interference of bothersome symptoms [Срок оценки: 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)]

Вторичные конечные точки (5)

• Self-care [Срок оценки: Measured at baseline and week 6 (T4)]
• HRQoL [Срок оценки: Measured at baseline and week 6 (T4)]
• Healthcare utilization [Срок оценки: Measured at baseline and week 6 (T4)]
• Healthcare utilization 2 [Срок оценки: Measured at baseline and week 6 (T4)]
• Healthcare utilization 3 [Срок оценки: Measured at baseline and week 6 (T4)]

Критерии участия

Критерии включения

• 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').

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Факторный дизайн

Маскирование

Открытое

Основная цель

Поддерживающая терапия

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07065578 · 25u-0131 · 03-004-2023-01

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗