Optimization of STAR

N/ANot Yet RecruitingNCT07065578

UMC Utrecht320 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

NONE

Interventions

STAR condition 1OTHER

* 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

STAR condition 2OTHER

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 logs; Verbal feedback HF nurse

STAR condition 3OTHER

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 logs; Verbal feedback HF nurse

STAR condition 4OTHER

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 logs; Written feedback HF nurse

STAR condition 5OTHER

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 logs; written feedback HF nurse

STAR condition 6OTHER

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 logs; Verbal feedback HF nurse

STAR condition 7OTHER

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 logs; Written feedback HF nurse

STAR condition 8OTHER

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 logs; Verbal feedback HF nurse

Outcomes

Primary Outcomes

Interference of bothersome symptoms

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.

Time frame: 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)

Secondary Outcomes

Self-care

Using the Self-Care Heart Failure Index version 7.2, scales self-care maintenance, symptom perception, and self-care management. Scores range from 0-100, scores higher than 70 indicate better self-care.