Why the study?
A three-pronged complex intervention underpinned by the extant cycle theory was developed to improve selfcare and deliver whole person care for patients with heart failure.
Population
301 patients aged ≥ 18 years with heart failure
Comparison
Three-pronged complex intervention vs not reported
Design
3-centre, 2-arm, 1:1, open, adaptive stratified, randomized controlled trial
Key result
A trial evaluating a complex intervention for heart failure recruited 301 patients (mean age 59.8 years), with 94.1% in the intervention arm having a Selfcare in Heart Failure Index score ≤70.
Authors
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High self-care deficits predominate in heart failure trial populations; extends rationale for complex interventions targeting knowledge barriers.
RCT (n=301)
Open-label
1:1, adaptive stratified
Yes
Kamath et al. (2023) conducted an RCT in heart failure (n=301). Complex intervention (lay health worker assessment, m-health remote monitoring, and dose optimization) was evaluated. A trial evaluating a complex intervention for heart failure recruited 301 patients (mean age 59.8 years), with 94.1% in the intervention arm having a Selfcare in Heart Failure Index score ≤70.