Optimization of STAR

UMC Utrecht

Status: Not yet enrolling

Conditions: Heart Failure NYHA Class II; Heart Failure NYHA Class III

Treatments: Other: STAR condition 7; Other: STAR condition 3; Other: STAR condition 4; Other: STAR condition 8; Other: STAR condition 6; Other: STAR condition 5; Other: STAR condition 1; Other: STAR condition 2

Study type: Interventional

Funder types: Other

Identifiers

NCT07065578

25u-0131

03-004-2023-01 (Other Identifier)

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 320 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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').

Exclusion criteria

• 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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: None (Open label)

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320 participants in 8 patient groups

Condition 1

Experimental group

Description:

Module 1: Low version; Module 2: Low version; Module 3: Low version

Treatment:

Other: STAR condition 1

Condition 2

Experimental group

Description:

Module 1: Low version; Module 2: Low version; Module 3: High version

Treatment:

Other: STAR condition 2

Condition 3

Experimental group

Description:

Module 1: Low version; Module 2: High version; Module 3: High version

Treatment:

Other: STAR condition 3

Condition 4

Experimental group

Description:

Module 1: Low version; Module 2: High version; Module 3: Low version

Treatment:

Other: STAR condition 4

Condition 5

Experimental group

Description:

Module 1: High version; Module 2: Low version; Module 3: Low version

Treatment:

Other: STAR condition 5

Condition 6

Experimental group

Description:

Module 1: High version; Module 2: Low version; Module 3: High version

Treatment:

Other: STAR condition 6

Condition 7

Experimental group

Description:

Module 1: High version; Module 2: High version; Module 3: Low version

Treatment:

Other: STAR condition 7

Condition 8

Experimental group

Description:

Module 1: High version; Module 2: High version; Module 3: High version

Treatment:

Other: STAR condition 8