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

NCT02425488 | Terminated DMC

• 1 other identifier: HFICD
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 2

Brief 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

Keywords

Nursing; Outcome and Process Assessment; Cardiac Resynchronization Therapy Devices; Heart Failure; Education

Outcome Measures

Primary Outcomes (1)

• Self-care levels (Self-Care Heart Failure Index (SCHFI) version 6.2)

  Increase of the Self Care competence, management and confidence with heart failure and the cardiac device

  12 months

Secondary Outcomes (4)

• Quality life perception

  12 months

• Visits to the ED

  12 months

• Mortality

  180 days

• Infection

  10 days

Other Outcomes (1)

• Costs saving

  12 months

Study Arms (2)

Nursing therapeutics education

EXPERIMENTAL

People who are educated by the nurse (Behavioral intervention: Nursing therapeutics education) and follow all the program (12 months)

Behavioral: Nursing therapeutics education

Non NET

NO INTERVENTION

People who receive basic information without follow the educational program but clinically controlled

Interventions

Nursing therapeutics education BEHAVIORAL

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

Nursing therapeutics education

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients affected by heart failure following elective hospitalization during which an ICD was implanted on an arrhythmic and/or ischemic basis.
• Patients who have given written consent for the research.

You may not qualify if:

• Patients with syndromes and diseases that compromise their understanding of information, learning and all cognitive activities in general.
• Minors.

Sponsors & Collaborators

• University of Turin, Italy: lead
• University of Rome Tor Vergata: collaborator

Study Sites (2)

Cardiovascular Department, Rivoli Hospital, ASL TO3

Rivoli, Turin, 10098, Italy

Location

Cardiovascular Department, Città della Salute e della Scienza, University Hospital

Turin, 100126, Italy

Location

Related Publications (7)

• Hickey A, Barker M, McGee H, O'Boyle C. Measuring health-related quality of life in older patient populations: a review of current approaches. Pharmacoeconomics. 2005;23(10):971-93. doi: 10.2165/00019053-200523100-00002.

  PMID: 16235972 BACKGROUND

• Moss AJ, Zareba W, Hall WJ, Klein H, Wilber DJ, Cannom DS, Daubert JP, Higgins SL, Brown MW, Andrews ML; Multicenter Automatic Defibrillator Implantation Trial II Investigators. Prophylactic implantation of a defibrillator in patients with myocardial infarction and reduced ejection fraction. N Engl J Med. 2002 Mar 21;346(12):877-83. doi: 10.1056/NEJMoa013474. Epub 2002 Mar 19.

  PMID: 11907286 BACKGROUND

• Pulignano G, Del Sindaco D, Minardi G, Tarantini L, Cioffi G, Bernardi L, Di Biagio D, Leonetti S, Giovannini E. Translation and validation of the Italian version of the European Heart Failure Self-care Behaviour Scale. J Cardiovasc Med (Hagerstown). 2010 Jul;11(7):493-8. doi: 10.2459/JCM.0b013e328335fbf5.

  PMID: 20407384 BACKGROUND

• Stromberg A. Educating nurses and patients to manage heart failure. Eur J Cardiovasc Nurs. 2002 Feb;1(1):33-40. doi: 10.1016/S1474-5151(01)00011-1.

  PMID: 14622865 BACKGROUND

• Aspromonte N, Di Tano G, Latini R, Masson S, Valle R, Emdin M. [Role of biomarkers for risk stratification in the tailored follow-up of heart failure patients]. G Ital Cardiol (Rome). 2010 May;11(5 Suppl 2):17S-23S. Italian.

  PMID: 20873464 BACKGROUND

• MacIntyre K, Capewell S, Stewart S, Chalmers JW, Boyd J, Finlayson A, Redpath A, Pell JP, McMurray JJ. Evidence of improving prognosis in heart failure: trends in case fatality in 66 547 patients hospitalized between 1986 and 1995. Circulation. 2000 Sep 5;102(10):1126-31. doi: 10.1161/01.cir.102.10.1126.

  PMID: 10973841 RESULT

• Cocchieri A, Riegel B, D'Agostino F, Rocco G, Fida R, Alvaro R, Vellone E. Describing self-care in Italian adults with heart failure and identifying determinants of poor self-care. Eur J Cardiovasc Nurs. 2015 Apr;14(2):126-36. doi: 10.1177/1474515113518443. Epub 2013 Dec 23.

  PMID: 24366984 RESULT

Related Links

• Italian register for discharge

MeSH Terms

Conditions

Heart Failure; Arrhythmias, Cardiac

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Maria Michela Gianino, Professor

  University of Turin, Italy

  STUDY DIRECTOR

• Sebastiano Marra, MD

  University of Turin, Italy

  STUDY CHAIR

• Angela Durante, RN

  Catholic University of Sacred Heart

  PRINCIPAL INVESTIGATOR

• Riccardo Sperlinga, MSC

  Catholic Universit of Sacred Heart

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor in Hygiene and Public Health

Study Record Dates

• First Submitted: April 20, 2015
• First Posted: April 24, 2015
• Study Start: April 1, 2015
• Primary Completion: October 29, 2017
• Study Completion: April 1, 2018
• Last Updated: May 7, 2018

Record last verified: 2018-05

Data Sharing

• IPD Sharing: Will not share

Locations

IT (2)