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

May 1, 2018 updated by: Prof. Maria Michela Gianino, University of Turin, Italy

Nursing Therapeutics Education and Heart Failure (HF): an Experimental Study

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Aims of the study The aim of this study is to examine the effects of a nursing intervention consisting of sanitary-therapeutic education during the follow-up period after the implantation of a defibrillator (ICD) in patients with congestive heart failure.

The effectiveness of the educational intervention will be assessed on the basis of the level of "self-care" in every individual and their lifestyle as well as on mortality rates, readmission to the hospital and ICD pocket infection.

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

    Materials and methods A multicenter randomized controlled study will be performed. The research project will involve two clinical centers in northern Italy: the "Città della Salute e della Scienza" University Hospital of Turin, which includes the "Molinette" Hospital (coordinator center), and the TO3 ASL, which includes the "Associated Hospitals of Rivoli".

    Subject recruitment and data collection will take place until data saturation is achieved, with an estimated period of approximately 12 months from the beginning of the study.

    Participants

    Inclusion criteria:

    • 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.

    Exclusion criteria:

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

    Primary outcome measures • Self-care levels (measured using the Self-Care Heart Failure Index, SCHFI v 6.2)

    • Quality of life perception (measured using a numerical rating scale from 0 to 100)

    Secondary outcome measures • Number of visits to the ED (Emergency Department) and/or hospitalizations during the follow-up period after the implantation of a defibrillator (ICD).

    • Mortality rate at 180 days after the implantation of the ICD due to HF-related causes.

    • Infection rate in the device pocket.

    Data, sources and collection tools • Socio-demographic and clinical data: For all of the included patients, demographic (gender, age, educational level, marital status, country of birth (Italian citizens or foreigners), social (through a family context survey) and clinical (classification of HF using the NYHA classification, the implantation date and type of ICD, the execution of and the changes in laboratory tests and electrocardiograms results, number of perceived discharges) data will be recorded. Data on the patient's diagnosis and possible associated diseases will be obtained through the analysis of clinical documentation and will be record in accordance with the International Statistical Classification of Diseases and Related Health Problems, 9th Revision (ICD-IX).

    • Economic data: For patients included in the study, the following data will be collected:

    • economic activity, occupational qualifications (if employed/ex-employed);

    • visits to the ED and/or hospitalizations during the follow-up period, verified through analysis of administrative documentation certifying visits and admissions (Verbal First Aid and Medical record);
    • the presence of a companion for the patients during their stay in the ED or hospital as well as their economic activity and professional qualifications;
    • any costs directly incurred by the patient or companion;
    • time spent by the nursing figure in providing therapeutic education. From society's point of view, the benefits received in the ED and hospitalizations will be assessed according to the charge currently in force in Italy. Indirect costs, represented by the time spent by the patient, and costs related to the time spent by caregivers will be valorized using values published by official sources such as ISTAT. Costs directly charged to the patient will be valued on the basis of the stated cost. Finally, the cost of time spent in educational activities will be assessed using the hourly average cost of a nurse and/or doctor in the clinical centers that participate in this study.
    • Self-Care Heart Failure Index (SCHFI) version 6.2. A tool validated in the Italian context that allows evaluation of a patient's awareness and capacity for self-care11. The obtained responses are organized on a four-level Likert scale (1 = never, 4 = every day). Specifically, this instrument is divided into three sections:

    Section A: (questions 1 to 10) investigates self-care skills; Section B: (questions 11 to 16) investigates an individual's symptomatology recognition skills; Section C: (questions 17 to 22) investigates the self-confidence related to self-care skills in detail.

    The total score is computed in the following manner:

    Section A: 10 is subtracted from the sum of the section results considering answers 1 to 10, and the result is multiplied by a coefficient of 3.33; Section B: 4 is subtracted from sum of the section results considering answers 11 to 16, and the result is multiplied by a coefficient of 5; Section C: 6 is subtracted from sum of the section results considering answers 17 to 22, and the result is multiplied by a coefficient of 5.56 All of the results have to be considered in terms of percentages. If the percentages for individual sections are all higher than the cut-off value (70%), then according to the literature11, the level of self-care is considered adequate. Otherwise, for lower values, the section showing an insufficient result will be strengthened.

    • Numeric Rating Scale: scale from 0 to 100 used for subjective measurement of the perceived quality of life. This tool will be evaluated by a committee of experts using a pre-test, which is currently under way.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
30

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Turin, Italy, 100126
        • Cardiovascular Department, Città della Salute e della Scienza, University Hospital
    • Turin
      • Rivoli, Turin, Italy, 10098
        • Cardiovascular Department, Rivoli Hospital, ASL TO3

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Nursing therapeutics education
People who are educated by the nurse (Behavioral intervention: Nursing therapeutics education) and follow all the program (12 months)
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
No Intervention: Non NET
People who receive basic information without follow the educational program but clinically controlled

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Self-care levels (Self-Care Heart Failure Index (SCHFI) version 6.2)
Time Frame: 12 months
Increase of the Self Care competence, management and confidence with heart failure and the cardiac device
12 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Quality life perception
Time Frame: 12 months
Increase in quality of life due to the development of management skills with heart disease
12 months
Visits to the ED
Time Frame: 12 months
Number of visits to the ED (Emergency Department) and/or hospitalizations during the follow-up period after the implantation of a defibrillator (ICD).
12 months
Mortality
Time Frame: 180 days
Mortality rate at 180 days after the implantation of the ICD due to HF-related causes
180 days
Infection
Time Frame: 10 days
Infection rate in the device pocket.
10 days

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Costs saving
Time Frame: 12 months
How many costs are saved by the health system, the society, the patient, the caregiver and the hospital; thanks to Nursing therapeutics education.
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Turin, Italy

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
University of Rome Tor Vergata

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Maria Michela Gianino, Professor, University of Turin, Italy
  • Study Chair: Sebastiano Marra, MD, University of Turin, Italy
  • Principal Investigator: Angela Durante, RN, Catholic University Of Sacred Heart
  • Principal Investigator: Riccardo Sperlinga, MSC, Catholic Universit of Sacred Heart

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 1, 2015

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 29, 2017

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 1, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 20, 2015

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 23, 2015

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 24, 2015

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 7, 2018

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 1, 2018

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • HFICD

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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