Optimization of STAR
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUMC Utrecht
About this trial
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.
Eligibility criteria
Qualifiers
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.
Disqualifiers
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
Treatments tested in this trial
- STAR condition 1
- STAR condition 2
- STAR condition 3
- STAR condition 4
- STAR condition 5
- STAR condition 6
- STAR condition 7
- STAR condition 8
Treatment groups
320 Participants
are divided into 8 treatment groups8
Treatment groupsSee each treatment group below.
Locations
Sponsors and collaborators
UMC Utrecht
Lead sponsor
Dutch Heart Foundation
Collaborator
Source ClinicalTrials.gov