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

Abstract

Background: Heart Failure (HF) is a common chronic disease that has a high readmission rate and is associated with worsening symptoms and major financial impacts. Disease management implemented during or after an HF hospitalization has been shown to reduce hospitalization and mortality rates. Particularly for outpatients, it is necessary to provide self-care interventions. Structured nurse-led support such as timely follow-ups, including phone calls, is beneficial for improving self-care assessments. Evidence for nurse-led support has been investigated but is less than conclusive. The aim of this study is to compare the effectiveness of a nurse-led structured intervention for outpatients with chronic HF against the usual medical care in terms of self-care behaviors and occurrence of symptom exacerbation or rehospitalization.

Methods and analysis: 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.

Keywords: European Heart Failure Self-Care Behavior Scale; heart failure; nurse-led structured intervention; self-care.

Figure 1

Schematic representation of the interventions in the intervention and control groups. This illustrates the frequency of interventions and the timing of questionnaire surveys in both the intervention and control groups. For the intervention group, there is a phone call on the third day, followed by face-to-face or phone interventions once a week for a month. After this initial month, both interventions continue once a month. In the control group, participants typically receive the usual care and are mostly asked to attend outpatient appointments two weeks later.

Figure 2

Baseline data collection sheet. This represents the pre-discharge data collection sheet, including the EHFScBS, European Heart Failure Self-Care Behavior Scale; NYHA, New York Heart Association; ACCF/AHA, American College of Cardiology Foundation/American Heart Association; MAGIC, Meta-Analysis Global Group in Chronic Heart Failure; BMI, body mass index; LVEF, left ventricular ejection fraction; BNP, brain natriuretic peptide; HDS-R, Revised Hasegawa’s dementia scale; MMSE, Mini Mental State Examination; and PHQ-9, Patient Health Questionnaire-9.