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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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Usual care group | No Intervention | Patients in the usual care group will receive usual care. | |
| ReDS-guided heart failure management group | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ReDS-guided heart failure management program | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Total number of acute healthcare visits for heart failure, unplanned heart failure hospitalisations, and all-cause death | 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Total number of acute healthcare visits for heart failure | 1 month, 3 months and 6 months | |
| Total number of unplanned hospitalisations for heart failure | 1 month, 3 months and 6 months | |
| Measure | Description | Time Frame |
|---|---|---|
| Healthcare costs | 1 month, 3 months and 6 months |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Naoko Perkiƶ Kato, PhD | Contact | +46 (0)11-36 31 17 | naoko.perkio.kato@liu.se |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Primary care center Centrum Flen | Recruiting | Flen | Sweden |
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| ID | Term |
|---|---|
| D006333 | Heart Failure |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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|
| Total number of all-cause death |
| 1 month, 3 months and 6 months |
| Number of days alive out of hospital | 1 month, 3 months and 6 months |
| Changes in NT-proBNP/BNP levels | 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. | 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. | 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. | 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). | Baseline, 1 month, 3 months and 6 months |