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NCT07065578Not yet recruiting

Optimization of STAR

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

Source: ClinicalTrials.gov · Last updated 15 Jul 2025 · Not updated for over 12 months - ask the site whether it is still open

Brief summary (registry, in English)

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.

Status (registry)
Not yet recruiting
Study type
Interventional
Enrollment
320 (estimated)
First submitted
19 Jun 2025
Start date
Jul 2025
Primary completion date
31 Mar 2027
Lead sponsor
UMC Utrecht
NCT number
NCT07065578

What you commit to

  • Study type: Interventional
  • Planned participants: 320
  • From Jul 2025 to the primary completion date, 31 Mar 2027
  • No sites listed in no country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other

  • 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.

Who the study is looking for

  • 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').

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

This page is information, not medical advice. Discuss any trial with your doctor.