Optimization of STAR

NCT ID: NCT07065578

Last Updated: 2025-07-15

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 320 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-07-31
• Study Completion Date: 2027-03-31

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.

Conditions

Heart Failure NYHA Class II; Heart Failure NYHA Class III

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: FACTORIAL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Condition 1

Module 1: Low version; Module 2: Low version; Module 3: Low version

Group Type: EXPERIMENTAL

STAR condition 1

Intervention Type: OTHER

• 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

Condition 2

Module 1: Low version; Module 2: Low version; Module 3: High version

Group Type: EXPERIMENTAL

STAR condition 2

Intervention Type: OTHER

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

Condition 3

Module 1: Low version; Module 2: High version; Module 3: High version

Group Type: EXPERIMENTAL

STAR condition 3

Intervention Type: OTHER

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

Condition 4

Module 1: Low version; Module 2: High version; Module 3: Low version

Group Type: EXPERIMENTAL

STAR condition 4

Intervention Type: OTHER

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

Condition 5

Module 1: High version; Module 2: Low version; Module 3: Low version

Group Type: EXPERIMENTAL

STAR condition 5

Intervention Type: OTHER

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

Condition 6

Module 1: High version; Module 2: Low version; Module 3: High version

Group Type: EXPERIMENTAL

STAR condition 6

Intervention Type: OTHER

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

Condition 7

Module 1: High version; Module 2: High version; Module 3: Low version

Group Type: EXPERIMENTAL

STAR condition 7

Intervention Type: OTHER

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

Condition 8

Module 1: High version; Module 2: High version; Module 3: High version

Group Type: EXPERIMENTAL

STAR condition 8

Intervention Type: OTHER

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

Interventions

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

Intervention Type: OTHER

STAR condition 2

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

Intervention Type: OTHER

STAR condition 3

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

Intervention Type: OTHER

STAR condition 4

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

Intervention Type: OTHER

STAR condition 5

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

Intervention Type: OTHER

STAR condition 6

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

Intervention Type: OTHER

STAR condition 7

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

Intervention Type: OTHER

STAR condition 8

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

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Dutch Heart Foundation

OTHER

Sponsor Role: collaborator

UMC Utrecht

OTHER

Sponsor Role: lead

Responsible Party

H.Westland

Dr.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Heleen Westland, PhD

Role: PRINCIPAL_INVESTIGATOR

UMC Utrecht

Tiny Jaarsma, PhD

Role: STUDY_CHAIR

UMC Utrecht and Linköping University

Central Contacts

Michelle van Rijn, MSc

Role: CONTACT

m.m.vanrijn-3@umcutrecht.nl

0031646927611

Heleen Westland, PhD

Role: CONTACT

h.westland@umcutrecht.nl

0031631119465

Other Identifiers

03-004-2023-01

Identifier Type: OTHER

Identifier Source: secondary_id

25u-0131

Identifier Type: -

Identifier Source: org_study_id