Remote dielectric sensing (ReDS) technology offers a non-invasive method for assessing lung congestion. This randomized controlled trial aims to evaluate the effectiveness and processes of the ReDS-guided heart failure management program in primary care settings for patients with heart failure.
Remote dielectric sensing (ReDS) technology offers a non-invasive method for assessing lung congestion. Our newly developed ReDS-guided heart failure management program, led by nurses, incorporates algorithms for a follow-up schedule, diuretic adjustments, and symptom monitoring. The specific aims of the study are: 1. To examine whether the program decreases the number of urgent healthcare visits for heart failure, unplanned heart failure hospitalisations, and all-cause death in patients with heart failure. 2. To evaluate the intervention processes and explore barriers to and facilitators for the implementation of the program. This is a multicentre 1:1 randomised controlled clinical trial with a 6-month follow-up. Study participants will be patients with diagnosed with heart failure. The primary outcome will be the total number of urgent healthcare visits for heart failure, unplanned heart failure hospitalisation, and all-cause death at 3 months. Secondary outcomes will include health-related quality of life, self-care behaviour, and healthcare cost. Throughout the randomised controlled trial, a process evaluation will be conducted to assess the fidelity, dose, and reach of the intervention program. Additionally, we will explore both barriers and facilitators for program implementation among study patients and healthcare professionals.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
330
Remote dielectric sensing (ReDS) system (Sensible Medical Innovations Ltd., Netanya, Israel) is a novel electromagnetic energy-based technology that accurately quantifies changes in lung fluid concentration non-invasively. Patients in the intervention group will receive a three-month, ReDS-guided heart failure management program in addition to usual care. The program, led by nurses, will integrate algorithms for diuretic use, a structured follow-up schedule, and self-care support tailored to pulmonary fluid levels assessed by ReDS.
Primary care center Centrum Flen
Flen, Sweden
RECRUITINGTotal number of acute healthcare visits for heart failure, unplanned heart failure hospitalisations, and all-cause death
Time frame: 3 months
Total number of acute healthcare visits for heart failure
Time frame: 1 month, 3 months and 6 months
Total number of unplanned hospitalisations for heart failure
Time frame: 1 month, 3 months and 6 months
Total number of all-cause death
Time frame: 1 month, 3 months and 6 months
Number of days alive out of hospital
Time frame: 1 month, 3 months and 6 months
Changes in NT-proBNP/BNP levels
Time frame: Baseline, 3 months and 6 months
Changes in the remote dielectric sensing (ReDS) values
The remote dielectric sensing (ReDS) system (Sensible Medical Innovations Ltd., Netanya, Israel) is a novel electromagnetic energy-based technology that accurately quantifies lung fluid content non-invasively. Normal ReDS values range from 20% to 35%. Values above 35% indicate hypervolemia, while values below 20% suggest dehydration.
Time frame: Baseline, 3 months and 6 months
Changes in the 12-item Kansas City Cardiomyopathy Questionnaire scores
The 12-item Kansas City Cardiomyopathy Questionnaire (KCCQ-12) is a validated instrument for quantitatively measuring health status for patients with heart failure. It contains four domains: physical limitation, symptom frequency, quality of life, and social limitations. The KCCQ-12 generates both summary and domain scores ranging from 0 to 100, where 0 represents the worst and 100 the best possible health status.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Time frame: Baseline, 1 month, 3 months and 6 months
Changes in the five-level EuroQol five-dimensional questionnaire (EQ-5D-5L) scores
The 5-level EuroQol-5 Dimension version (EQ-5D-5L) assesses five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension is rated on five levels, with higher scores indicating better health-related quality of life.
Time frame: Baseline, 1 month, 3 months and 6 months
Changes in the heart failrue self-care behaviour scores
The European Heart Failure Self-Care Behaviour Scale (EHFScBS) is a 9-item scale, with higher scores indicating poorer self-care (range: 9-45).
Time frame: Baseline, 1 month, 3 months and 6 months