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

Heart Failure Clinical Trial

— PEAC-IC  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05081414
• Other study ID #: 2021-01
• Secondary ID: PE 1118/2019Proc
• Status: Completed
• Phase: N/A
• Start date: October 26, 2021
• Est. completion date: March 30, 2023

Study information

• Verified date: March 2023
• Source: University of Sao Paulo
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 56
• Est. completion date: March 30, 2023
• Est. primary completion date: October 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Heart Failure

Intervention

Behavioral:
• Program for Teaching Self-Care in HF (PEAC-IC)
As described previously

Locations

Country	Name	City	State
Brazil	Instituto Dante Pazzanese de Cardiologia	São Paulo	SP

Sponsors (2)

Lead Sponsor	Collaborator
University of Sao Paulo	Instituto Dante Pazzanese de Cardiologia

Country where clinical trial is conducted

Brazil, 

References & Publications (8)

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. — View Citation

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. — View Citation

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, S — View Citation

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 behavio — View Citation

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. — View Citation

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. — View Citation

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 Perspe — View Citation

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 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Primary	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	Change in quality of Life	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.
Secondary	Change in search for emergency medical care due to clinical decompensation of Heart Failure	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.
Secondary	Change in hospitalization due to clinical decompensation of Heart Failure	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.
Secondary	Change in feeling of Powerlessness	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.
Secondary	Change in Depressive symptoms	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.