Nursing Therapeutics Education and Heart Failure (HF): a Study Protocol

Summary

Purpose: Heart Failure (HF) is a clinical multifactorial syndrome, it can cause arrhythmias for which international guidelines suggest the implantation of an implantable cardiac defibrillator (ICD). The educational nursing program would improve clinical outcomes in patients with HF and ICD like control their sickness, known and acknowledge symptoms, improve their skills to self-care.

The main aim of this study is to assess how much the nursing-therapeutics skills and an educational intervention, in patients with HF during the follow-up period after the implantation of ICD reduces clinical costs, re-hospitalizations, and mortality at 180 days.

Methods: The investigators start a multicenter randomized clinical trial. The sample is made of 128 subjects (64 patients treatment group and 64 control group). The investigators measured the self-care level administering to HF patients the "Self-Care of Heart Failure Index (SCHFI) v. 6.2", and the self-perception of own life quality using a Numeric Rating Scale from 0 to 100. Secondary outcomes recorded are i) the numbers of accesses to the ED (Emergency Department) and/or hospitalizations during the follow-up period, ii) mortality rate due to HF, and iii) infection rate of the device pocket.

Data Analysis: Categorical variables will be presented in terms of frequencies and percentages. The statistical power was fixed at the 80%. Data will be considered significant for a p-value ≤ 0.05. The Cox proportional hazards model will be used to analyze mortality in subjects involved in the educational program.

Conditions

• Heart Failure
• Arrhythmia

Interventions

BEHAVIORAL

Nursing therapeutics education

Educational intervention will focus on 1. Appropriate lifestyles 2. Early recognition of signs/prodromal symptoms of HF 3. Early recognition of signs of inflammation of the ICD-pocket 4. Good management of the device 1\) Therapy, body weight, diet, smoking, alcohol, rest, exercise, job and sex 2) Dyspnea, edema and fovea, rapid weight gain, loss of appetite, fatigue, asthenia, insomnia, mental confusion 3) Signs and symptoms of inflammation: hyperpyrexia, rubor, dolor, calor and tumor 4) Identification tag, vibration, metal detectors, air travel, use of electronic devices, diagnostic PET and MRI

Sponsors & Collaborators

• University of Rome Tor Vergata

  collaborator OTHER

• University of Turin, Italy

  lead OTHER

Principal Investigators

• Maria Michela Gianino, Professor · University of Turin, Italy

• Sebastiano Marra, MD · University of Turin, Italy

• Angela Durante, RN · Catholic University of Sacred Heart

• Riccardo Sperlinga, MSC · Catholic Universit of Sacred Heart

Study Design

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2015-04-30

Primary Completion

2017-10-29

Completion

2018-04-30

Countries

• Italy

Study Locations