NCT05081414

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
56

participants targeted

Target at P25-P50 for not_applicable heart-failure

Timeline
Completed

Started Oct 2021

Shorter than P25 for not_applicable heart-failure

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 11, 2021

Completed
1 month until next milestone

First Posted

Study publicly available on registry

October 18, 2021

Completed
8 days until next milestone

Study Start

First participant enrolled

October 26, 2021

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 30, 2022

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 30, 2023

Completed
Last Updated

April 4, 2023

Status Verified

March 1, 2023

Enrollment Period

1 year

First QC Date

September 11, 2021

Last Update Submit

March 31, 2023

Conditions

Heart Failure

Keywords

NursingSelf-CareHeart-FailreHealth EducationClinical Trial

Outcome Measures

Primary Outcomes (2)

  • Change in Self-care behavior

    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

    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 Outcomes (5)

  • Change in 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

    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

    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

    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

    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.

Study Arms (2)

Intervention Group

EXPERIMENTAL

Beyond the active comparator, this group will receive the PEAC-IC, as described previously.

Behavioral: Program for Teaching Self-Care in HF (PEAC-IC)

Control Group

NO INTERVENTION

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.

Interventions

Program for Teaching Self-Care in HF (PEAC-IC)BEHAVIORAL

As described previously

Intervention Group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • Patients proven to be diagnosed with COVID-19
  • Display adequate self-care and confidence in self-care (≥70 points) on the all EAC-IC subscales (SCHFI 6.2 brazilian version).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Instituto Dante Pazzanese de Cardiologia

São Paulo, São Paulo, Brazil

Location

Related Publications (8)

  • da Conceicao AP, dos Santos MA, dos Santos B, da Cruz Dde A. Self-care in heart failure patients. Rev Lat Am Enfermagem. 2015 Jul-Aug;23(4):578-86. doi: 10.1590/0104-1169.0288.2591.

    PMID: 26444158BACKGROUND

  • Carvalho VO, Guimaraes GV, Carrara D, Bacal F, Bocchi EA. Validation of the Portuguese version of the Minnesota Living with Heart Failure Questionnaire. Arq Bras Cardiol. 2009 Jul;93(1):39-44. doi: 10.1590/s0066-782x2009000700008. English, Portuguese, Spanish.

    PMID: 19838469BACKGROUND

  • Ruppar TM, Cooper PS, Johnson ED, Riegel B. Self-care interventions for adults with heart failure: A systematic review and meta-analysis protocol. J Adv Nurs. 2019 Mar;75(3):676-682. doi: 10.1111/jan.13903. Epub 2018 Dec 21.

    PMID: 30397943RESULT

  • Sevilla-Cazes J, Ahmad FS, Bowles KH, Jaskowiak A, Gallagher T, Goldberg LR, Kangovi S, Alexander M, Riegel B, Barg FK, Kimmel SE. Heart Failure Home Management Challenges and Reasons for Readmission: a Qualitative Study to Understand the Patient's Perspective. J Gen Intern Med. 2018 Oct;33(10):1700-1707. doi: 10.1007/s11606-018-4542-3. Epub 2018 Jul 10.

    PMID: 29992429RESULT

  • Jaarsma T, Hill L, Bayes-Genis A, La Rocca HB, Castiello T, Celutkiene J, Marques-Sule E, Plymen CM, Piper SE, Riegel B, Rutten FH, Ben Gal T, Bauersachs J, Coats AJS, Chioncel O, Lopatin Y, Lund LH, Lainscak M, Moura B, Mullens W, Piepoli MF, Rosano G, Seferovic P, Stromberg A. Self-care of heart failure patients: practical management recommendations from the Heart Failure Association of the European Society of Cardiology. Eur J Heart Fail. 2021 Jan;23(1):157-174. doi: 10.1002/ejhf.2008. Epub 2020 Oct 20.

    PMID: 32945600RESULT

  • Jaarsma T, Stromberg A, Ben Gal T, Cameron J, Driscoll A, Duengen HD, Inkrot S, Huang TY, Huyen NN, Kato N, Koberich S, Lupon J, Moser DK, Pulignano G, Rabelo ER, Suwanno J, Thompson DR, Vellone E, Alvaro R, Yu D, Riegel B. Comparison of self-care behaviors of heart failure patients in 15 countries worldwide. Patient Educ Couns. 2013 Jul;92(1):114-20. doi: 10.1016/j.pec.2013.02.017. Epub 2013 Apr 8.

    PMID: 23579040RESULT

  • Riegel B, Dickson VV, Faulkner KM. The Situation-Specific Theory of Heart Failure Self-Care: Revised and Updated. J Cardiovasc Nurs. 2016 May-Jun;31(3):226-35. doi: 10.1097/JCN.0000000000000244.

    PMID: 25774844RESULT

  • Vellone E, De Maria M, Iovino P, Barbaranelli C, Zeffiro V, Pucciarelli G, Durante A, Alvaro R, Riegel B. The Self-Care of Heart Failure Index version 7.2: Further psychometric testing. Res Nurs Health. 2020 Dec;43(6):640-650. doi: 10.1002/nur.22083. Epub 2020 Nov 3.

    PMID: 33141495RESULT

MeSH Terms

Conditions

Heart FailureHealth Education

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular DiseasesAdherence InterventionsMedication AdherencePatient CompliancePatient Acceptance of Health CareTreatment Adherence and ComplianceHealth BehaviorBehavior

Study Officials

  • Michele Nakahara-Melo, MsC

    University of Sao Paulo

    PRINCIPAL INVESTIGATOR

  • Diná Monteiro da Cruz, PhD

    University of Sao Paulo

    STUDY CHAIR

  • Ana Paula da Conceição, PhD

    Instituto Dante Pazzanese de Cardiologia

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: PEAC-IC encompasses one presential session and five weekly telephone sessions, focusing on the promotion of self-care and a patient book with all information discussed in the presential session and more 2 diaries, one for the daily weight monitoring and other to assess the symptoms and the and another for monitoring symptoms, making decisions about them and the results obtained. The participants in the intervention group in addition to the patient book will also receive a mechanical scale and a liquid control jar to control the edema and water intake, respectively.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

September 11, 2021

First Posted

October 18, 2021

Study Start

October 26, 2021

Primary Completion

October 30, 2022

Study Completion

March 30, 2023

Last Updated

April 4, 2023

Record last verified: 2023-03

Data Sharing

IPD Sharing
Will share

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.

Shared Documents
STUDY PROTOCOL, SAP, ICF, CSR
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.
Access Criteria
Upon request to the responsible researchers.
More information

Locations

BR(1)