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

NCT ID: NCT05081414

Last Updated: 2023-04-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 56 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-10-26
• Study Completion Date: 2023-03-30

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.

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.

Conditions

Heart Failure

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: SINGLE

Study Groups

Intervention Group

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

Group Type: EXPERIMENTAL

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

Intervention Type: BEHAVIORAL

As described previously

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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

As described previously

Intervention Type: BEHAVIORAL

Eligibility Criteria

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).

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Instituto Dante Pazzanese de Cardiologia

OTHER

Sponsor Role: collaborator

University of Sao Paulo

OTHER

Sponsor Role: lead

Responsible Party

Michele Nakahara Melo

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Michele Nakahara-Melo, MsC

Role: PRINCIPAL_INVESTIGATOR

University of Sao Paulo

Diná Monteiro da Cruz, PhD

Role: STUDY_CHAIR

University of Sao Paulo

Ana Paula da Conceição, PhD

Role: STUDY_DIRECTOR

Instituto Dante Pazzanese de Cardiologia

Locations

Instituto Dante Pazzanese de Cardiologia

São Paulo, São Paulo, Brazil

Countries

Brazil

References

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.

Reference Type: BACKGROUND

PMID: 26444158 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 19838469 (View on PubMed)

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.

Reference Type: RESULT

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Reference Type: RESULT

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Reference Type: RESULT

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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.

Reference Type: RESULT

PMID: 23579040 (View on PubMed)

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.

Reference Type: RESULT

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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.

Reference Type: RESULT

PMID: 33141495 (View on PubMed)

Other Identifiers

PE 1118/2019

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

Process 2020/15834-8

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

2021-01

Identifier Type: -

Identifier Source: org_study_id