Optimization of STAR

NCT07065578 | Not Yet Recruiting

• 2 other identifiers: 25u-013103-004-2023-01
• Study Type: interventional
• Target: 320
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Heart Failure NYHA Class II; Heart Failure NYHA Class III

Keywords

Heart Failure; Self-management; symptom management; Self-care; e-Health

Outcome Measures

Primary Outcomes (1)

• 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.

  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

  Measured at baseline and week 6 (T4)

• HRQoL

  Measured at baseline and week 6 (T4)

• Healthcare utilization

  Measured at baseline and week 6 (T4)

• Healthcare utilization 2

  Measured at baseline and week 6 (T4)

• Healthcare utilization 3

  Measured at baseline and week 6 (T4)

Other Outcomes (9)

• Illness perceptions

  Measured at week 1 (T1) and week 2-3 (T2 )

• HF knowledge

  Measured at baseline and week 1 (T1)

• Interoception

  Measured at baseline, week 1(T1), week 2-3 (T2), week 6 (T4)

Study Arms (8)

Condition 1

EXPERIMENTAL

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

Other: STAR condition 1

Condition 2

EXPERIMENTAL

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

Other: STAR condition 2

Condition 3

EXPERIMENTAL

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

Other: STAR condition 3

Condition 4

EXPERIMENTAL

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

Other: STAR condition 4

Condition 5

EXPERIMENTAL

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

Other: STAR condition 5

Condition 6

EXPERIMENTAL

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

Other: STAR condition 6

Condition 7

EXPERIMENTAL

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

Other: STAR condition 7

Condition 8

EXPERIMENTAL

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

Other: STAR condition 8

Interventions

STAR condition 1 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 1

STAR condition 2 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 2

STAR condition 3 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 3

STAR condition 4 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 4

STAR condition 5 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 5

STAR condition 6 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 6

STAR condition 7 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 7

STAR condition 8 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

Condition 8

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosed with HF (irrespective of ejection fraction) and symptomatic NYHA class II or III.
• 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').

You may not qualify if:

• Participants living in a care facility (e.g. nursing home, revalidation center).
• Language barrier preventing sufficient understanding and communication in Dutch.

Sponsors & Collaborators

• UMC Utrecht: lead
• Dutch Heart Foundation: collaborator

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Officials

• Heleen Westland, PhD

  UMC Utrecht

  PRINCIPAL INVESTIGATOR

• Tiny Jaarsma, PhD

  UMC Utrecht and Linköping University

  STUDY CHAIR

Central Study Contacts

Michelle van Rijn, MSc

CONTACT

0031646927611; m.m.vanrijn-3@umcutrecht.nl

Heleen Westland, PhD

CONTACT

0031631119465; h.westland@umcutrecht.nl

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr.

Model Details: 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.

Study Record Dates

• First Submitted: June 19, 2025
• First Posted: July 15, 2025
• Study Start: July 1, 2025
• Primary Completion (Estimated): March 31, 2027
• Study Completion (Estimated): March 31, 2027
• Last Updated: July 15, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share