NCT Number: NCT07065578
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.
Trial opening soon.
Get Notified18 year and older
All sexes
Interventional
Not applicable
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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
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
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
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
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
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
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
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.
Time frame: Measured at baseline and week 6 (T4)
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)
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)
Using hospital data: number of HF-related ER and hospital admissions
Time frame: Measured at baseline and week 6 (T4)
Using hospital data: Length of stay in days
Time frame: Measured at baseline and week 6 (T4)
Using hospital data: Number of unscheduled (telephone) consultations with the HF outpatient clinic).
Time frame: Measured at week 1 (T1) and week 2-3 (T2 )
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 baseline and week 1 (T1)
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, week 1(T1), week 2-3 (T2), week 6 (T4)
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: week 2-3 (T2)
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: Measured at week 2-3 (T2) and at week 6 (T4)
Confidence will be measured using the 10-item Self Care Self-Efficacy Scale measuring self-care self-efficacy in chronic illness. The standardized score range from 0-100. Scores >70 indicate better self-care confidence.
Time frame: Measured at week 4 (T3) and week 6 (T4)
Symptom management skills will be evaluated with 8-item Control Attitudes Scale-Revised. Range score is 8-40, higher scores indicate greater perceived control.
Time frame: Measured at week 1 (T1), week 2-3 (T2), week 4 (T3), week 6 (T4)
Treatment fidelity will be evaluated with the user logs of the platform of patient and nurse. Written feedback from HF nurses to patients in each module will be evaluated using self-assessments for the HF nurses. The number of minutes of the verbal feedback in each module will be registered by nurses.
Time frame: Measured at week 4 (T3)
Descriptive analysis of self-assessments made by patients in module 2.
Time frame: Measured at the end of the intervention week 7-8
Experiences of patients will be evaluated using semi-structured interviews. We aim to include 5 participants per version per module (total 40 participants). All participating HF nurses are asked to share their experiences with the research team at the end of the intervention.
Contact information is provided by the study sponsor or research team.
Heleen Westland, PhD
CONTACT
Michelle van Rijn, MSc
CONTACT
UMC Utrecht
Other
Optimization of the STAR Intervention on Self-care Symptom Management in Patients With Heart Failure
Acronym: STAR
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