Optimization of STAR (NCT07065578) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Optimization of STAR
320 participantsStarted 2025-07
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Interference of bothersome symptoms
Timeframe: 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)