Heart Failure NYHA Class IISTARNCT07065578
Optimization of STAR
A study testing STAR condition 1, STAR condition 2 and STAR condition 3 in people with Heart Failure NYHA Class II and Heart Failure NYHA Class III, run by UMC Utrecht.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure NYHA Class II, Heart Failure NYHA Class III
- What is being tested?
- STAR condition 1, STAR condition 2 and STAR condition 3
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 320 participants
- Where
- No sites listed yet
- Study dates
- Jul 2025to 31 Mar 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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').
Who cannot join
- 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 locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Optimization of the STAR Intervention on Self-care Symptom Management in Patients With Heart Failure
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.
Read the 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.
- Being tested
- STAR condition 1, STAR condition 2, STAR condition 3, STAR condition 4, STAR condition 5
- Keywords
- Heart Failure, Self-management, symptom management, Self-care, e-Health
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
STAR condition 1Other
- Basic module: HF information and doing symptom awareness exercises.
- Low version Module 1: Symptom awareness exercises 2 times in 1 week, and written feedback HF nurse
- Low version Module 2: Coaching in symptom management response and choose symptom response option to experiment with. Written feedback from HF nurse
- Low version Module 3: Instruction and doing symptom management experiments for 2 weeks + keep logs; Written feedback HF nurse
STAR condition 2Other
Basic module: aims to improve the participant's illness perceptions and standardize HF knowledge at the start of the intervention and doing exercises.- Low version Module 1: Symptom awareness exercises 2 times in 1 week, and written feedback HF nurse - Low version Module 2: Coaching in symptom management response and choose symptom response option to experiment with. Written feedback from HF nurse - High version Module 3: Instruction and doing symptom management experiments for 2 weeks + keep logs; Verbal feedback HF nurse
STAR condition 3Other
Basic module: aims to improve the participant's illness perceptions and standardize HF knowledge at the start of the intervention and doing exercises.- Low version Module 1: Symptom awareness exercises 2 times in 1 week, and written feedback HF nurse - High version Module 2: Coaching in symptom management response and choose symptom response option to experiment with. Verbal feedback from HF nurse - High version Module 3: Instruction and doing symptom management experiments for 2 weeks + keep logs; Verbal feedback HF nurse
STAR condition 4Other
Basic module: aims to improve the participant's illness perceptions and standardize HF knowledge at the start of the intervention and doing exercises.- Low version Module 1: Symptom awareness exercises 2 times in 1 week, and written feedback HF nurse - High version Module 2: Coaching in symptom management response and choose symptom response option to experiment with. Verbal feedback from HF nurse - Low version Module 3: Instruction and doing symptom management experiments for 2 weeks + keep logs; Written feedback HF nurse
STAR condition 5Other
Basic module: aims to improve the participant's illness perceptions and standardize HF knowledge at the start of the intervention and doing exercises.- High version Module 1: Symptom awareness exercises 6 times in 2 weeks, and verbal feedback HF nurse - Low version Module 2: Coaching in symptom management response and choose symptom response option to experiment with. Written feedback from HF nurse - Low version Module 3: Instruction and doing symptom management experiments for 2 weeks + keep logs; written feedback HF nurse
STAR condition 6Other
Basic module: aims to improve the participant's illness perceptions and standardize HF knowledge at the start of the intervention and doing exercises.- High version Module 1: Symptom awareness exercises 6 times in 2 weeks, and verbal feedback HF nurse - Low version Module 2: Coaching in symptom management response and choose symptom response option to experiment with. Written feedback from HF nurse - High version Module 3: Instruction and doing symptom management experiments for 2 weeks + keep logs; Verbal feedback HF nurse
STAR condition 7Other
Basic module: aims to improve the participant's illness perceptions and standardize HF knowledge at the start of the intervention and doing exercises.- High version Module 1: Symptom awareness exercises 6 times in 2 weeks, and verbal feedback HF nurse - High version Module 2: Coaching in symptom management response and choose symptom response option to experiment with. Verbal feedback from HF nurse - Low version Module 3: Instruction and doing symptom management experiments for 2 weeks + keep logs; Written feedback HF nurse
STAR condition 8Other
Basic module: aims to improve the participant's illness perceptions and standardize HF knowledge at the start of the intervention and doing exercises.- High version Module 1: Symptom awareness exercises 6 times in 2 weeks, and verbal feedback HF nurse - High version Module 2: Coaching in symptom management response and choose symptom response option to experiment with. Verbal feedback from HF nurse - High version Module 3: Instruction and doing symptom management experiments for 2 weeks + keep logs; Verbal feedback HF nurse
| Study group | Role | What they receive |
|---|---|---|
| Condition 1 | Experimental | Module 1: Low version; Module 2: Low version; Module 3: Low version Receives: Other: STAR condition 1 |
| Condition 2 | Experimental | Module 1: Low version; Module 2: Low version; Module 3: High version Receives: Other: STAR condition 2 |
| Condition 3 | Experimental | Module 1: Low version; Module 2: High version; Module 3: High version Receives: Other: STAR condition 3 |
| Condition 4 | Experimental | Module 1: Low version; Module 2: High version; Module 3: Low version Receives: Other: STAR condition 4 |
| Condition 5 | Experimental | Module 1: High version; Module 2: Low version; Module 3: Low version Receives: Other: STAR condition 5 |
| Condition 6 | Experimental | Module 1: High version; Module 2: Low version; Module 3: High version Receives: Other: STAR condition 6 |
| Condition 7 | Experimental | Module 1: High version; Module 2: High version; Module 3: Low version Receives: Other: STAR condition 7 |
| Condition 8 | Experimental | Module 1: High version; Module 2: High version; Module 3: High version Receives: Other: STAR condition 8 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Interference of bothersome symptoms
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.
Measured: 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)
Secondary outcomes (5)
Self-care
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.
Measured: Measured at baseline and week 6 (T4)
HRQoL
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.
Measured: Measured at baseline and week 6 (T4)
Healthcare utilization
Using hospital data: number of HF-related ER and hospital admissions
Measured: Measured at baseline and week 6 (T4)
Healthcare utilization 2
Using hospital data: Length of stay in days
Measured: Measured at baseline and week 6 (T4)
Healthcare utilization 3
Using hospital data: Number of unscheduled (telephone) consultations with the HF outpatient clinic).
Measured: Measured at baseline and week 6 (T4)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2025
- Study startJul 2025 (estimated)
- Primary completion31 Mar 2027 (estimated)
- Study completion31 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart Failure NYHA Class IIStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Factorial
- Model description
- This study has a randomized factorial experimental design with 2\^3 = 8 experimental conditions to examine the effects of the three individual key modules. With this design, the main effects of each module and the interaction between modules will be tested. After informed consent, participants will be randomized using stratified block randomization to one of the eight experimental conditions within each participating HF clinic.
- Masking
- None (open label)
- Enrolment
- 320 participants (estimated)
Sponsor and investigators
- Lead sponsor
- UMC Utrecht
- Sponsor type
- University, hospital or other
- Collaborators
- Dutch Heart Foundation
- Responsible party
- Principal investigator, H.Westland, UMC Utrecht
- Investigators
- Heleen Westland, PhD, Principal investigator, UMC UtrechtTiny Jaarsma, PhD, Study chair, UMC Utrecht and Linköping University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07065578
- Sponsor's protocol ID
- 25u-0131
- Other IDs
- 03-004-2023-01
- Acronym
- STAR
- Status last verified
- Jul 2025
- First submitted
- 19 Jun 2025
- Last updated
- 15 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Interested parties can request access to this data-set via our institutional data access committee (DC) for the EGA; based on the assessment of the DAC access to this data-set will be granted or declined.
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimization of the STAR Intervention on Self-care Symptom Management in Patients With Heart Failure
- ClinicalTrials.gov ID
- NCT07065578
- Acronym / sponsor ID
- STAR / 25u-0131
- Keywords
- Heart Failure, Self-management, symptom management, Self-care, e-Health
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 320 participants (estimated)
- Lead sponsor
- UMC UtrechtUniversity, hospital or other
- Collaborators
- Dutch Heart Foundation
- Study start
- Jul 2025 (estimated)
- Primary completion
- 31 Mar 2027 (estimated)
- Study completion
- 31 Mar 2027 (estimated)
- First posted
- 15 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 8
- Model description
- This study has a randomized factorial experimental design with 2^3 = 8 experimental conditions to examine the effects of the three individual key modules. With this design, the main effects of each module and the interaction between modules will be tested. After informed consent, participants will be randomized using stratified block randomization to one of the eight experimental conditions within each participating HF clinic.
| Arm | Type | Receives |
|---|---|---|
| Condition 1 | Experimental | Other: STAR condition 1Module 1: Low version; Module 2: Low version; Module 3: Low version |
| Condition 2 | Experimental | Other: STAR condition 2Module 1: Low version; Module 2: Low version; Module 3: High version |
| Condition 3 | Experimental | Other: STAR condition 3Module 1: Low version; Module 2: High version; Module 3: High version |
| Condition 4 | Experimental | Other: STAR condition 4Module 1: Low version; Module 2: High version; Module 3: Low version |
| Condition 5 | Experimental | Other: STAR condition 5Module 1: High version; Module 2: Low version; Module 3: Low version |
| Condition 6 | Experimental | Other: STAR condition 6Module 1: High version; Module 2: Low version; Module 3: High version |
| Condition 7 | Experimental | Other: STAR condition 7Module 1: High version; Module 2: High version; Module 3: Low version |
| Condition 8 | Experimental | Other: STAR condition 8Module 1: High version; Module 2: High version; Module 3: High version |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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').
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| STAR condition 1* Basic module: HF information and doing symptom awareness exercises. * Low version Module 1: Symptom awareness exercises 2 times in 1 week, and written feedback HF nurse * Low version Module 2: Coaching in symptom management response and choose symptom response option to experiment with. Written feedback from HF nurse * Low version Module 3: Instruction and doing symptom management experiments for 2 weeks + keep logs; Written feedback HF nurse | Other | Condition 1 |
| STAR condition 2Basic module: aims to improve the participant's illness perceptions and standardize HF knowledge at the start of the intervention and doing exercises.- Low version Module 1: Symptom awareness exercises 2 times in 1 week, and written feedback HF nurse - Low version Module 2: Coaching in symptom management response and choose symptom response option to experiment with. Written feedback from HF nurse - High version Module 3: Instruction and doing symptom management experiments for 2 weeks + keep logs; Verbal feedback HF nurse | Other | Condition 2 |
| STAR condition 3Basic module: aims to improve the participant's illness perceptions and standardize HF knowledge at the start of the intervention and doing exercises.- Low version Module 1: Symptom awareness exercises 2 times in 1 week, and written feedback HF nurse - High version Module 2: Coaching in symptom management response and choose symptom response option to experiment with. Verbal feedback from HF nurse - High version Module 3: Instruction and doing symptom management experiments for 2 weeks + keep logs; Verbal feedback HF nurse | Other | Condition 3 |
| STAR condition 4Basic module: aims to improve the participant's illness perceptions and standardize HF knowledge at the start of the intervention and doing exercises.- Low version Module 1: Symptom awareness exercises 2 times in 1 week, and written feedback HF nurse - High version Module 2: Coaching in symptom management response and choose symptom response option to experiment with. Verbal feedback from HF nurse - Low version Module 3: Instruction and doing symptom management experiments for 2 weeks + keep logs; Written feedback HF nurse | Other | Condition 4 |
| STAR condition 5Basic module: aims to improve the participant's illness perceptions and standardize HF knowledge at the start of the intervention and doing exercises.- High version Module 1: Symptom awareness exercises 6 times in 2 weeks, and verbal feedback HF nurse - Low version Module 2: Coaching in symptom management response and choose symptom response option to experiment with. Written feedback from HF nurse - Low version Module 3: Instruction and doing symptom management experiments for 2 weeks + keep logs; written feedback HF nurse | Other | Condition 5 |
| STAR condition 6Basic module: aims to improve the participant's illness perceptions and standardize HF knowledge at the start of the intervention and doing exercises.- High version Module 1: Symptom awareness exercises 6 times in 2 weeks, and verbal feedback HF nurse - Low version Module 2: Coaching in symptom management response and choose symptom response option to experiment with. Written feedback from HF nurse - High version Module 3: Instruction and doing symptom management experiments for 2 weeks + keep logs; Verbal feedback HF nurse | Other | Condition 6 |
| STAR condition 7Basic module: aims to improve the participant's illness perceptions and standardize HF knowledge at the start of the intervention and doing exercises.- High version Module 1: Symptom awareness exercises 6 times in 2 weeks, and verbal feedback HF nurse - High version Module 2: Coaching in symptom management response and choose symptom response option to experiment with. Verbal feedback from HF nurse - Low version Module 3: Instruction and doing symptom management experiments for 2 weeks + keep logs; Written feedback HF nurse | Other | Condition 7 |
| STAR condition 8Basic module: aims to improve the participant's illness perceptions and standardize HF knowledge at the start of the intervention and doing exercises.- High version Module 1: Symptom awareness exercises 6 times in 2 weeks, and verbal feedback HF nurse - High version Module 2: Coaching in symptom management response and choose symptom response option to experiment with. Verbal feedback from HF nurse - High version Module 3: Instruction and doing symptom management experiments for 2 weeks + keep logs; Verbal feedback HF nurse | Other | Condition 8 |
Primary outcome
Interference of bothersome symptoms
Time frame: 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.
5 secondary outcomes
Self-care
Time frame: Measured at baseline and week 6 (T4)
HRQoL
Time frame: Measured at baseline and week 6 (T4)
Healthcare utilization
Time frame: Measured at baseline and week 6 (T4)
Healthcare utilization 2
Time frame: Measured at baseline and week 6 (T4)
Healthcare utilization 3
Time frame: Measured at baseline and week 6 (T4)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jul 2025.
- Individual participant dataSharing planned: No. Interested parties can request access to this data-set via our institutional data access committee (DC) for the EGA; based on the assessment of the DAC access to this data-set will be granted or declined.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Heleen Westland, PhD principal investigator
UMC Utrecht
Tiny Jaarsma, PhD study chair
UMC Utrecht and Linköping University
Questions about this trial
What is this clinical trial studying?
A study testing STAR condition 1, STAR condition 2 and STAR condition 3 in people with Heart Failure NYHA Class II and Heart Failure NYHA Class III, run by UMC Utrecht.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 15 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Michelle van Rijn, MSc (0031646927611, m.m.vanrijn-3@umcutrecht.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Interference of bothersome symptoms (time frame: 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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jul 2025.