Clinical trial NCT06734065: Effect of Non-Invasive Lung Fluid Monitoring for Heart Failure Management in Primary Care
Official title: Effect of Non-Invasive Lung Fluid Monitoring Using ReDS Technology for Heart Failure Management in Primary Care Settings: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Heart Failure
Keywords: Heart failure
Primary care
Nursing
Monitoring
Self-care
Community
Lead sponsor: Linkoeping University
Sponsor class: OTHER_GOV
First posted: 2024-12-16
Enrollment: 330
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* Age ≥ 18 years, there is no upper age limit
* Diagnosed with heart failure regardless of left ventricular ejection fraction
* Having New York Heart Association (NYHA) Class III/IV irrespective of prior hospitalisation for heart failure, or NYHA II with a history of at least one hospitalisation for heart failure within the previous 12 months
* Elevated N-terminal pro-B-type natriuretic peptide (NT-proBNP) within 12 months: (a) ≥450 pg/ml for patients under 50 years; (b) ≥900 pg/ml for patients aged 50-75 years; (c) ≥1800 pg/ml for patients over 75 years.

Exclusion Criteria:

* NYHA I
* Life expectancy \<6 months
* Physical characteristics that prevented use of the ReDS (body mass index \< 22 or \>39, and height less than 155 cm or higher than 195 cm)
* Implantation of a left ventricular assist device or cardiac transplantation.

Primary outcomes:
measure: Total number of acute healthcare visits for heart failure, unplanned heart failure hospitalisations, and all-cause death
timeFrame: 3 months
Secondary outcomes:
measure: Total number of acute healthcare visits for heart failure
timeFrame: 1 month, 3 months and 6 months
measure: Total number of unplanned hospitalisations for heart failure
timeFrame: 1 month, 3 months and 6 months
measure: Total number of all-cause death
timeFrame: 1 month, 3 months and 6 months
measure: Number of days alive out of hospital
timeFrame: 1 month, 3 months and 6 months
measure: Changes in NT-proBNP/BNP levels
timeFrame: Baseline, 3 months and 6 months
measure: Changes in the remote dielectric sensing (ReDS) values
timeFrame: Baseline, 3 months and 6 months
measure: Changes in the 12-item Kansas City Cardiomyopathy Questionnaire scores
timeFrame: Baseline, 1 month, 3 months and 6 months
measure: Changes in the five-level EuroQol five-dimensional questionnaire (EQ-5D-5L) scores
timeFrame: Baseline, 1 month, 3 months and 6 months
measure: Changes in the heart failrue self-care behaviour scores
timeFrame: Baseline, 1 month, 3 months and 6 months
Other outcomes:
measure: Healthcare costs
timeFrame: 1 month, 3 months and 6 months
Locations:
city: Flen
country: Sweden
facility: Primary care center Centrum Flen
Study officials:
References: