Health TrialsbyHealthPanel

Optimization of STAR

ConditionsHeart Failure NYHA Class IIHeart Failure NYHA Class III
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

This trial does not accept healthy volunteers

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

Design model

Factorial

Treatments tested in this trial

  • STAR condition 1

    Other intervention

    * 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 2

    Other intervention

    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 3

    Other intervention

    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 4

    Other intervention

    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 5

    Other intervention

    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 6

    Other intervention

    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 7

    Other intervention

    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 8

    Other intervention

    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

Treatment groups

320 Participants
are divided into 8 treatment groups

8

Treatment groups

See each treatment group below.

Group A: Condition 1Experimental treatment 1 intervention
Group B: Condition 2Experimental treatment 1 intervention
Group C: Condition 3Experimental treatment 1 intervention
Group D: Condition 4Experimental treatment 1 intervention
Group E: Condition 5Experimental treatment 1 intervention
Group F: Condition 6Experimental treatment 1 intervention
Group G: Condition 7Experimental treatment 1 intervention
Group H: Condition 8Experimental treatment 1 intervention

Trial outcomes

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.

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)

Secondary outcomes

1

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.

Time frame
Measured at baseline and week 6 (T4)
2

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.

Time frame
Measured at baseline and week 6 (T4)
3

Healthcare utilization

Using hospital data: number of HF-related ER and hospital admissions

Time frame
Measured at baseline and week 6 (T4)
4

Healthcare utilization 2

Using hospital data: Length of stay in days

Time frame
Measured at baseline and week 6 (T4)

Other outcomes

1

Illness perceptions

Illness perception will be measured with the 8-item Brief-Illness perception Questionnaire, assessing patients' cognitive and emotional representations of illness. The score range is 0-80. Higher scores indicate worse illness perception.

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

HF knowledge

15-item Dutch Heart Failure Knowledge Scale will be used to measure HF knowledge in general, HF treatment, and HF symptoms and symptom recognition. Range of score is 0-15, with higher scores representing optimal knowledge.

Time frame
Measured at baseline and week 1 (T1)
3

Interoception

The 37-item Multidimensional Assessment of Interoceptive Awareness version 2 will be used to measure eight dimensions of interoception (noticing, not-distracting, not-worrying, attention regulation, emotional awareness, self-regulation, body listening, trust). Scale scores are 0-5, where higher scores indicate more interoceptive awareness.

Time frame
Measured at baseline, week 1(T1), week 2-3 (T2), week 6 (T4)
4

Symptom attribution

The Illness Perception Questionnaire (revised) identity scale will be used to measure symptom attribution. Participants will be asked if they have experienced a number of symptoms since their illness, and if they feel the symptoms are related to their current illness. Response is by answering 'yes' or 'no' to each symptom. The number of yes-rated items are summed to give an overall score (range 0- 21). A high score represents strongly held beliefs about the number of symptoms attributed to HF.

Time frame
week 2-3 (T2)

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

UMC Utrecht

Lead sponsor

Dutch Heart Foundation

Collaborator

Source ClinicalTrials.gov

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