Clinical trial NCT05081414: Efficacy of the PEAC-IC: a Randomized Controlled Clinical Trial
Official title: Efficacy of The Program for Teaching Self-Care in Heart Failure (PEAC-IC): a Randomized Controlled Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Heart Failure
Keywords: Nursing
Self-Care
Heart-Failre
Health Education
Clinical Trial
Lead sponsor: University of Sao Paulo
Sponsor class: OTHER
Collaborators: name: Instituto Dante Pazzanese de Cardiologia
First posted: 2021-10-18
Enrollment: 56
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: SUPPORTIVE_CARE

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.

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).

Primary outcomes:
measure: Change in Self-care behavior
timeFrame: 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.
measure: Change in Knowledge on Heart Failure
timeFrame: 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:
measure: Change in quality of Life
timeFrame: 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.
measure: Change in search for emergency medical care due to clinical decompensation of Heart Failure
timeFrame: 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.
measure: Change in hospitalization due to clinical decompensation of Heart Failure
timeFrame: 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.
measure: Change in feeling of Powerlessness
timeFrame: 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.
measure: Change in Depressive symptoms
timeFrame: 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.
Other outcomes:
Locations:
city: São Paulo
country: Brazil
facility: Instituto Dante Pazzanese de Cardiologia
state: SP
Study officials:
affiliation: University of Sao Paulo
name: Michele Nakahara-Melo, MsC
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Sao Paulo
name: Diná Monteiro da Cruz, PhD
role: STUDY_CHAIR
affiliation: Instituto Dante Pazzanese de Cardiologia
name: Ana Paula da Conceição, PhD
role: STUDY_DIRECTOR
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