Optimization of STAR

Not Applicable

Not yet recruiting

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

• Registration Number: NCT07065578
• Lead Sponsor: UMC Utrecht

Brief Summary

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.

Detailed 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.

Study Timeline

• Study First Submitted: 2025-06-19
• Status Verified: 2025-07
• Study Start: 2025-07-01
• Study First Submitted QC: 2025-07-03
• Last Update Submitted: 2025-07-03
• Study First Posted: 2025-07-15
• Last Update Posted: 2025-07-15
• Primary Completion: 2027-03-31
• Study Completion: 2027-03-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 320

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Primary Outcome Measures

Name	Time	Method
Interference of bothersome symptoms	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.

Secondary Outcome Measures

Name	Time	Method
Self-care	Measured at baseline and week 6 (T4)	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.
HRQoL	Measured at baseline and week 6 (T4)	The 23-item Kansas City Cardiomyopathy Questionnaire will be used to evaluate the Health related Quality of life of patients with HF. The items are divided into five domains: physical limitations, social limitations, symptoms, self-efficacy, and quality of life.; Scores are standardized on a scale from 0 to 100, higher scores represent fewer symptoms and better overall health status.
Healthcare utilization	Measured at baseline and week 6 (T4)	Using hospital data: number of HF-related ER and hospital admissions
Healthcare utilization 2	Measured at baseline and week 6 (T4)	Using hospital data: Length of stay in days
Healthcare utilization 3	Measured at baseline and week 6 (T4)	Using hospital data: Number of unscheduled (telephone) consultations with the HF outpatient clinic).