Efficacy of the PEAC-IC: a Randomized Controlled Clinical Trial (PEAC-IC)

March 31, 2023 updated by: Michele Nakahara Melo, University of Sao Paulo

Efficacy of The Program for Teaching Self-Care in Heart Failure (PEAC-IC): a Randomized Controlled Clinical Trial

A randomized parallel single-center clinical trial, blinded for the evaluation of the outcomes and statistical analysis. The current hypothesis is that PEAC-IC will improve self-care behavior, knowledge about heart failure, health-related quality of life, and the number of hospitalizations and searches for emergency services in the participants with heart failure.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Heart failure (HF) is an insidious chronic syndrome that impacts the quality of life of people affected by it. One of the ways of controlling the progression of the syndrome is self-care, which involves behaviors to maintain health and to monitor and manage the symptoms of the disease. Several studies have shown that when the person with HF has adequate self-care, there is a reduction in the rate of morbidity and mortality, hospital readmissions, and an improvement in the quality of life. Despite the benefits of self-care, it is still deficient among people with HF in Brazil and worldwide. To improve self-care, educational interventions for the development of skills and behaviors must be performed by nurses, due to their role concerning health education. The Programa Educativo para o Autocuidado na Insuficiência Cardíaca - PEAC-IC is an intervention created to promote the achievement of positive results for people with HF. In a pilot study, PEAC-IC was assessed for acceptability and feasibility, with satisfactory preliminary results. Main objective: To compare the effect of the PEAC-IC with the usual care on self-care behavior, on knowledge about heart failure, on health-related quality of life, and on the number of hospitalizations and searches for emergency services due to HF. Method: This is a randomized parallel single-center clinical trial, blinded for the evaluation of the outcomes and statistical analysis. Participants (1. adults and elderly hospitalized for HF, adults and elderly with HF follow in outpatient care) who meet the participation criteria will be randomized in a simple random way between the intervention and control groups. The intervention group will receive the usual care and the PEAC-IC, offered in one face-to-face session and five structured telephone contacts. The control group will receive only the usual care, which consists of guidance during hospital discharge and delivery of a discharge planning form and outpatient follow-up with medical and nursing consultations and exams when indicated. Both groups will have the outcome variables assessed at baseline, in the seventh week, in the third and sixth months after allocation in the trial. This study will be carried out at the Clinical Cardiological Unit with 42 active beds and a cardiomyopathy outpatient clinic that offer a multidisciplinary health care of approximately 70 clinically stable patients with HF of the Instituto Dante Pazzanese de Cardiologia (IDPC), a public teaching hospital specializing in cardiovascular care. The research will be appreciated by the Research Ethics Committee and will only start after a favorable opinion at the University of São Paulo School of Nursing and the hospital.

Study Type

Interventional

Enrollment (Actual)

56

Phase

  • 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

  • Brazil
    • SP
      • São Paulo, SP, Brazil
        • Instituto Dante Pazzanese de Cardiologia

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

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Be regularly enrolled in the outpatient clinic;
  2. Having a confirmed diagnosis of HF, regardless of the etiology or having been hospitalized due to clinical mismatch of the syndrome
  3. Have clinical conditions that allow to participate in interviews, as assessed by the researcher;
  4. Have an active telephone contact;
  5. Be able to listen, speak, read and write portuguese, as assessed by the researcher;

Exclusion Criteria:

  1. Patients in the postoperative period of cardiac surgery (up to 60 days after the operation or requiring surgical intervention after inclusion in the study) or any surgical intervention that may increase the demands of self-care.
  2. Patients proven to be diagnosed with COVID-19
  3. Patients in palliative care, according to the evaluation of the institution's health team, at any time of the research, that is, even after inclusion and randomization.
  4. Display adequate self-care and confidence in self-care (≥70 points) on the all EAC-IC subscales (SCHFI 6.2 brazilian version).

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
Intervention / Treatment
Experimental: Intervention Group
Beyond the active comparator, this group will receive the PEAC-IC, as described previously.
Behavioral: Program for Teaching Self-Care in HF (PEAC-IC)
As described previously
No Intervention: Control Group
The Control Group will receive the usual care in the health care institution, which consists of guidance during hospital discharge and delivery of a discharge planning form and outpatient follow-up with medical and nursing consultations and exams when indicated.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Self-care behavior
Time Frame: Self-Care of Heart Failure Index v.6.2 will be assessed at the - T1: research participant allocation, T2: seven weeks after allocation, 3 months after T2 and 6 months after T2.
Self-care behavior will be assessed by the Brazilian version of the Self-Care of Heart Failure Index v.6.2 (SCHFI), the Self-Care Scale for Patients with Heart Failure, adapted and validated for use in Brazil. This scale consists of 22 items divided into three subscales. The scores for each subscale can range from 0 to 100 points, and scores equal to or greater than 70, in any subscale, reflect adequate self-care.
Self-Care of Heart Failure Index v.6.2 will be assessed at the - T1: research participant allocation, T2: seven weeks after allocation, 3 months after T2 and 6 months after T2.
Change in Knowledge on Heart Failure
Time Frame: Disease Knowledge Questionnaire will be assessed at the - T1: research participant allocation, T2: seven weeks after allocation, 3 months after T2 and 6 months after T2.
The "Disease Knowledge Questionnaire will assess knowledge on Heart failure for Patients with Heart Failure", created and validated for use in Brazil. It consists of 19 items: the HF pathophysiology contents, its concept, diagnosis, risk factors, symptoms, lifestyle habits, treatment, medications used, self-care, and physical exercise. For each item, there are four alternatives: one is the correct answer; one is incomplete; one is incorrect and one is "I don't know". According to the total score obtained, can be categorized as excellent (51 to 57 points); good (40 to 50 points); acceptable (29 to 39 points); little knowledge (17 to 28 points) and insufficient knowledge (< 17 points).
Disease Knowledge Questionnaire will be assessed at the - T1: research participant allocation, T2: seven weeks after allocation, 3 months after T2 and 6 months after T2.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in quality of Life
Time Frame: Health-related Quality of Life will be assessed at the - T1: research participant allocation, T2: seven weeks after allocation, 3 months after T2 and 6 months after T2.
Quality of Life will be asses using the Minnesota Living with Heart Failure Questionnaire, the validated Portuguese version. The instrument consists of 21 items that assess the participants' perception regarding how much the signs and symptoms of HF made it impossible/limited the daily activities or the activities that the participants would like to perform/perform. These items refer to the physical, emotional and socioeconomic aspects that the presence of HF can impact and the answers range from zero to five points (0: nothing; 1: very little to 5: too much). The final score is obtained through the sum of the answers of the 21 items and can range from zero to 105 points, the higher the score, the worse the quality of life and the lower the score, the better quality of life.
Health-related Quality of Life will be assessed at the - T1: research participant allocation, T2: seven weeks after allocation, 3 months after T2 and 6 months after T2.
Change in search for emergency medical care due to clinical decompensation of Heart Failure
Time Frame: Will be assessed at the - T1: research participant allocation (number of times during the last 12 months), T2: seven weeks after allocation, 3 months after T2 and 6 months after T2.
Number of times reported by the participant or family member/caregiver of fearch for emergency medical care due to clinical decompensation of Heart Failure
Will be assessed at the - T1: research participant allocation (number of times during the last 12 months), T2: seven weeks after allocation, 3 months after T2 and 6 months after T2.
Change in hospitalization due to clinical decompensation of Heart Failure
Time Frame: Will be assessed at the - T1: research participant allocation (number of times during the last 12 months), T2: seven weeks after allocation, 3 months after T2 and 6 months after T2.
Number of times reported by the participant or family member/caregiver of hospitalization due to clinical decompensation of Heart Failure
Will be assessed at the - T1: research participant allocation (number of times during the last 12 months), T2: seven weeks after allocation, 3 months after T2 and 6 months after T2.
Change in feeling of Powerlessness
Time Frame: Will be assessed at the - T1: research participant allocation (number of times during the last 12 months), T2: seven weeks after allocation, 3 months after T2 and 6 months after T2.
The feeling of powerlessness will be assessed by the Powerlessness assessment tool, created and validated in adults in the process of hospitalization. It consists of 12 items divided into three domains: the ability to perform a behavior, perception of the ability to make decisions and emotional response to control situations. The possibilities of answering the 12 items range from 'never to 'always' scored from 1 to 5. A cutoff score is not provided for interpreting the results. However, the higher the score, the more intense the feeling of impotence. The score obtained through this instrument will be treated as a continuous quantitative variable, for further categorization under the guidance of a statistician.
Will be assessed at the - T1: research participant allocation (number of times during the last 12 months), T2: seven weeks after allocation, 3 months after T2 and 6 months after T2.
Change in Depressive symptoms
Time Frame: Will be assessed at the - T1: research participant allocation (number of times during the last 12 months), T2: seven weeks after allocation, 3 months after T2 and 6 months after T2.
The Depressive symptoms will be assessed by the Depression Scale CES-D (Center for Epidemiologic Studies Depression Scale) which aims to identify depressive mood and a possible vulnerability to depression. This instrument was created by the NIMH - National Institute of Mental Health and consists of 20 items that measure the occurrence of depressive symptoms, such as mood, somatic symptoms, interactions with other people, and motor functioning, from the frequency of symptoms in the last week to interview. The score for the 20 items can range from 0 to 3 and the response options range from rarely or never, a few times, sometimes, almost always, or always. Thus, the total score varies between zero and sixty points. The occurrence of depressive symptoms is considered from a score of ≥ 16 points
Will be assessed at the - T1: research participant allocation (number of times during the last 12 months), T2: seven weeks after allocation, 3 months after T2 and 6 months after T2.

Collaborators and Investigators

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

Sponsor

University of Sao Paulo

Collaborators

Instituto Dante Pazzanese de Cardiologia

Investigators

  • Principal Investigator: Michele Nakahara-Melo, MsC, University of Sao Paulo
  • Study Chair: Diná Monteiro da Cruz, PhD, University of Sao Paulo
  • Study Director: Ana Paula da Conceição, PhD, Instituto Dante Pazzanese de Cardiologia

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

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 (Actual)

October 26, 2021

Primary Completion (Actual)

October 30, 2022

Study Completion (Actual)

March 30, 2023

Study Registration Dates

First Submitted

September 11, 2021

First Submitted That Met QC Criteria

October 5, 2021

First Posted (Actual)

October 18, 2021

Study Record Updates

Last Update Posted (Actual)

April 4, 2023

Last Update Submitted That Met QC Criteria

March 31, 2023

Last Verified

March 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2021-01
  • PE 1118/2019 (Other Grant/Funding Number: CAPES)
  • Process 2020/15834-8 (Other Grant/Funding Number: FAPESP)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

All variables will be collected and transcribed into the Research Electronic Data Capture (REDCap) application, which will be used for data recording, secure storage, database manipulation. All variables collected will be documented as metadata, and the identity of the participants, such as name and initials, which allow any identification, will be removed from the spreadsheets that will be made available in the repositories. The researcher will keep, outside the application, a listing that will allow the participant to be identified, if necessary during the study. The sharing of metadata in the repositories will be subject to the consent of the participants, and such information will be included in the Consent Form.

The data will be stored in the cloud and a daily backup of the collected data is provided.

IPD Sharing Time Frame

The metadata will be available upon request to the responsible researchers as soon as the research is completed for an indefinite time.

The researchers responsible for the study that generated the database will be able to, independently, use it for secondary analyses, as long as they ensure reference to the primary study.

IPD Sharing Access Criteria

Upon request to the responsible researchers.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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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