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Propelling Nurse-Led Structured Intervention to Enhance Self-Care among Patients with Chronic Heart Failure (PROACT-HF): A Cluster Randomized Controlled Trial Study Protocol.

Momoko OkazakiTakahiro SuzukiAtsushi MizunoToshimi IkegameNoriki ItoMai OnodaIkuko MiyawakiYuka MoriyamaTaku YabukiSatomi YamadaDaisuke YoneokaYuko IwasawaKyoko TagamiKumiko Yoshikawa
Published in: Journal of personalized medicine (2024)
This is a cluster-randomized controlled trial. A total of 40 facilities with certified HF nurses will be allocated to two-arm clusters at a 1:1 ratio, randomly to the intervention or usual care arms. A total of 210 participants will be assigned from the hospital. Participants will be adults aged 18 years or older diagnosed with chronic HF who are classified as Stage C according to the ACCF/AHA Heart Failure staging system. In the intervention group, patients will receive structured nursing support. This begins with weekly support, including phone calls, for the first month, then transitions to monthly support thereafter. The aim is to ensure the stability of their living conditions, promote medication adherence, and encourage self-management. In the control group, patients will receive the usual care. Primary outcomes will assess the improvement or continuation of self-care behavior as measured by changes in EHFScBS (European Heart Failure Self-Care Behavior Scale) scores. Secondary outcomes include occurrence of readmission within 30 days, 3 months, 6 months, and 1 year after discharge, duration of home care until readmission, and blood levels of BNP and NT-proBNP.
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