Effect of an orientation group for patients with chronic heart failure: randomized controlled trial 1

ABSTRACT Objective: To evaluate the effect of the orientation group on therapeutic adherence and self-care among patients with chronic heart failure. Method: Randomized controlled trial with 27 patients with chronic heart failure. The intervention group received nursing consultations and participated in group meetings with the multi-professional team. The control group only received nursing consultations in a period of four months. Questionnaires validated for use in Brazil were applied in the beginning and in the end of the study to assess self-care outcomes and adherence to treatment. Categorical variables were expressed through frequency and percentage distributions and the continuous variables through mean and standard deviation. The comparison between the initial and final scores of the intervention and control groups was done through the Student’s t-test. Results: The mean adherence in the intervention group was 13.9 ± 3.6 before the study and 4.8 ± 2.3 after the study. In the control group it was 14.2 ± 3.4 before the study and 14.7 ± 3.5 after the study. The self-care confidence score was lower after the intervention (p=0.01). Conclusion: The orientation group does not improve adherence to treatment and self-care management and maintenance and it may reduce confidence in self-care. Registry REBEC RBR-7r9f2m.


Introduction
Despite the development of new technologies, scientific advances and the achievement of better social and economic conditions in recent decades, a high incidence of heart failure (HF) is still frequently observed in Brazil and in the world (1) .
Limiting symptoms such as fatigue, dyspnea and angina are common in these patients and may be accompanied by memory loss and difficulty in concentration, making them incapable and restricting them in their activities of daily living (2)(3) . This decrease in functional capacity may compromise adherence to treatment and self-care, leading to higher rates of hospitalization and death (4) .
A study found a low rate of self-care in 116 patients with HF and attributed this data to the rates of 44.8% patients with cognitive impairment and 52.6% with no nursing follow-up (5) .
Educational programs are an important tool to improve the management of self-care by the multi-professional team specialized in the follow-up of patients with HF (6) .
However, it is difficult to identify the appropriate strategies and scenarios, since the interventions are heterogeneous, as well as the number of professionals involved, hindering the evaluation of results (5) .
Thus, nurses working in specialized HF clinics seek strategies that can increase adherence to treatment and enhance self-care, improving quality of life and reducing hospital readmissions (5)(6)(7) . Group interventions are one of the strategies for disease management programs (8)(9)(10)(11) .
However, there are no studies that have proven their effectiveness in adherence to treatment and in self-care management, maintenance and confidence.
An integrative review of 42 articles on interventions proposed and implemented by nurses to optimize selfcare in patients with HF found that most of the studies were directed to patients, excluding the participation of caregivers and family members, and addressed three to four factors of self-care, such as diet, adherence to medication, daily weight, physical activity and monitoring of signs and symptoms of decompensated HF. There was a predominance of verbal instructions, but written materials and information technology such as CD-ROMs, DVDs and videos, as well as telehealth, were also used. Few studies discussed group activities (12) .
Orientation groups are used as a supplement to the guidelines provided during the outpatient visit. A study conducted in the Netherlands evaluated self-care and quality of life among 317 HF patients for 12 months after participating in 21 group sessions. The intervention showed improvements in cognitive management of symptoms (p<0.001), self-care behavior (p=0.008) and quality of life (p=0.005), but no effect was found in six and 12 months of follow-up (10) .
A systematic review evaluated orientation groups in populations with chronic diseases such as asthma, hypertension, heart failure, diabetes mellitus, arthritis, among others, but provided little evidence on the achievement of good outcomes in quality of life and health management. The study suggested that more studies should be carried out, especially in order to compare the orientation groups with other strategies (11) .
Thus, this study aimed to evaluate the effect of the orientation group on adherence to treatment and self-care among patients with chronic HF in a specialized clinic.

Method
This is a randomized controlled trial with parallelgroup developed with two groups at the same time, an intervention group (orientation group and nursing consultation) and a control group (nursing consultation).
The study was conducted between October 2012 and February 2014. The inclusion criteria were patients on follow-up in a clinic specialized in heart failure, in the city of Niteroi/RJ, Brazil, who were over 18 years old, diagnosed with HF and included in functional class I to III according to the New York Heart Association (NYHA).
Exclusion criteria were patients with an acute myocardial infarction (AMI) in the three months prior to the study; patients who underwent coronary artery bypass surgery in the month prior to the study or who were indicated for surgery; patients with neurological/cognitive dysfunction; patients who did not live in the cities of Niteroi, São Gonçalo or Rio de Janeiro; and patients who did not have a landline. The intervention occurred during 120 days, with two (02) nursing consultations and sixteen (16) fortnightly group meetings with the intervention group (IG).
The 105 eligible patients were contacted and blindly randomized to the control group and intervention group.
Only 56 patients answered the request and then were invited to the study, received orientation and signed a consent form (TCLE) informing on the benefits and risks of the study. At the first visit, the first evaluation of adherence and self-care maintenance, management and confidence was carried out through questionnaires previously adapted and validated for use in Brazil (13)(14) .
At each nursing visit, a specialist nurse conducted anamnesis, physical examination and evaluation of complementary and laboratory tests. Nursing diagnoses were identified and an educational intervention was conducted through reading of a Guideline on Heart Failure (15) from the Coração Valente Heart Failure Clinic with the patient and companions. This guideline is used in the conventional follow-up of these patients. In addition, the nursing visit was also used to improve the prescribed treatment.
The intervention "orientation group" was based on the classification of Support Group from the Nursing Intervention Classification (NIC) (16) . This intervention is defined as "using a group environment to provide its members with emotional support and health-related information".
Eight different topics were programmed for the orientation group, based on the recommendations of the Brazilian Guideline for Heart Failure (15) according to figure 1. The topics were presented with 15 days intervals, however, the same topics were repeated for two consecutive weeks, favoring the participation of the patients. The topics, the objectives and the interventions used are described below.
Week Theme Objective Intervention 1 and 2 Definition of heart failure and main care To define Heart Failure and its main symptoms Bingo presentation; Presentation of a video.

and 4
Symptoms of decompensated HF, how to intervene?
To present the main signs and symptoms of heart failure and the main activities to reduce them.  Patients who did not participate in at least three meetings with the orientation group were excluded, which totaled one (01) loss per month.
The control group (CG) received the conventional follow-up from the HF Clinic, which consists of nursing, nutritional, physiotherapy and medical consultations.
During the nursing consultation, the patients of this group also received an educational intervention based on the Guideline on Heart Failure.
The outcomes assessed in this study were adherence to treatment (17) and self-care maintenance, management and confidence among patients with HF (10) in a specialized clinic. Outcomes were assessed at the first visit and reassessed after four months of follow-up.
Adherence to treatment was assessed through a questionnaire with 10 questions, with scores ranging from 0 to 26 points; higher scores indicate better adherence.
Adherence is considered adequate when the patient reaches 18 points score, which corresponds to 70% (15) .
On the self-care maintenance scale, responses range from "never/rarely" to "always/daily". On the self-care management scale, responses range from "unlikely" to "very likely" and on the self-care confidence they range from "not confident" to "extremely confident". The questions are about weight and edemas, physical activity, attendance at consultations, diet, medications, signs and symptoms of decompensated HF, management of signs and symptoms, and confidence in decision making (14) .
The scores of each subscale were calculated separately, and each ranged from 0 to 100 points. A self-care score of 70 or more points was considered adequate (14) .
The sample estimate was based on the standard deviation of a previous clinical trial (14) for the same outcomes conducted with HF patients who received nursing interventions. This study set a 95% confidence interval, a margin of error of five percentage points, and power of 80%. Therefore, the inclusion of 20 patients (10 in each group) was estimated. A nine-point difference between groups was considered, based on the outcome of the study in question. The sample calculation was performed using the Winpepi statistical program (v. 14.46).

Results
Of the 105 patients eligible to participate in the study, fifty-six (56) met the inclusion criteria. Of these, twentynine (29) were allocated in the intervention group (IG) and twenty seven (27) in the control group (CG).
During the study, the IG had eighteen (18)  The outcomes adherence to treatment and self-care maintenance, management and confidence were evaluated in the initial and final moments of the study, with the scores of the intervention group, the control group and the total sample are presented in Table 2.
The initial scores of adherence (14.1 ± 3.4), selfcare maintenance (43.8 ± 15.5), self-care management (56.3 ± 29.1) and self-care confidence (62.0 ± 23.9) were lower than the expected for the total population, which was above 18 points for adherence and 70 points on the self-care scales.
There were no significant differences in the outcomes assessed in the initial and final moments between the control and intervention groups. The mean difference obtained at the initial moment and at the end of the followup period in the control group and in the intervention group were in adherence (0.47) (p=0.79); maintenance (-3.54) (p=0.54); management (15.73) (p= 0.32) and confidence (-29.38), but the latter was the only statistically significant one (p=0,005), according to Table 3.
There were no significant differences in the control and intervention groups between the initial and final results. The exception was the self-care confidence score that had a significant negative difference in the intervention group, meaning it was higher in the beginning of the study.     (9) and Control Group (11).

Discussion
This study evaluated for the first time the effect of an orientation group on the outcomes adherence to treatment and self-care maintenance, management and confidence in patients with chronic HF in a specialized clinic in Brazil.
The outcomes were assessed through questionnaires previously translated, adapted and validated for use in Brazil. The results showed that the orientation group was not effective for improving adherence and self-care, and could lead to a reduction in self-care confidence. directly influence this aspect (18)(19) .
The initial scores of the sample were low in adherence (14.11 ± 3.41), self-care maintenance (43.82 ± 15.54), self-care management (56.26 ± 29.10) and self-care confidence (62.01 ± 23.94). Using as evaluation methods two scales used worldwide for self-care assessment, the Self-care Heart Failure Index and the European Heart Failure Self-Care, a comparison between self-care in 15 countries showed better indexes in developed countries (9,(20)(21) .
In a study with 197 Americans with HF, 56.1% with NYHA III, the self-care maintenance score was (70.5 ± 14.3), the self-care management score was (65. 4 ± 22.4) and self-care confidence score was (70.2 ± 16.6) (22) . All these values are higher than we found in this study. The education of the patient related to better educational and socioeconomic conditions, may be the explanation for the difference between these scores, since in this study more than 80% of the interviewees had only elementary education I and II.
In the Chinese population, with a population of 182 patients with HF, from three hospitals, 71% men and 79% with NYHA II/III, the scores were: self-care maintenance (43.5 ± 16.7), self-care management (51.4 ± 21.6) and self-care confidence (52.0 ± 21.1);. They had self-care maintenance scores similar to this study and lower confidence score (21) .
The comprehension of the orientation provided may vary depending on the level of education, and the intervention should be adapted to this condition. In addition, access to the medication prescribed may be impaired, since it may be difficult for patients to correctly understand what is prescribed in order to acquire these medications (18) .
Therefore, low education level and income are predictors for low adherence to treatment and self-care, leading to decompensated HF and increasing hospital readmissions (23) .
In this study, the strategies used in the orientation group were based on recreational activities, such as movies On the other hand, the negative change in the self-care confidence score in the IG can be attributed to the knowledge acquired during the orientation group meetings. Perhaps, the comprehension of the condition, the stage of the disease, its incurability, and the difficulties experienced by several patients may amplify the patients' perception and make them feel insecure to state that they are extremely confident in these issues.
People normally can't judge themselves, so they usually feel capable and confident to carry out tasks. Unaware of their ignorance, they overestimate their experience and talent, and consider themselves competent (24) . This overestimation is more frequent among the less capable, since the more competent can recognize their true level of abilities and compare it with others (5) .
Thus, before the intervention group, the participants were more confident. As they became more competent to evaluate their health status and self-care, their selfreport was more real, which may explain their lower level of self-care confidence.
It is also important to understand the full scope of the concepts of adherence and self-care. These matters go beyond monitoring of signs and symptoms, and should include issues such as comfort, environment, emotional factors, support system such as family and friends, basic hygiene, sleep and rest, eating habits, daily activities, work, leisure and ability to communicate and interact with the world (25) . A study that aimed to discover why patients with HF participated or not in a self-care support program found that the main reasons for permanence in these programs were support, friendship, exchanging information, acceptance and control of the disease, exchange of experiences and combating depression. However, the most relevant causes for abandonment were the physical impairment imposed by illness, depression, uninteresting educational materials, and very small groups or individual strategies (26) .
Thus, the results found should be analysed with caution, and multicenter studies with longer follow-up periods should be conducted in order to obtain a better evaluation of the orientation group and its effect on adherence and self-care. However, this study was relevant, since, in a controlled manner, through a randomized controlled trial, it evidenced the difficulties of investigating the effect of group interventions for patients with HF.
A 6-month home and telephone follow-up study demonstrated a 27% relative reduction in the outcomes hospitalization, emergency care, or death. The study also improved HF knowledge and self-care actions (27) .
Thus, longer follow-up periods with combined strategies seem to be better for promoting adherence and enhancing self-care for this type of patients. Therefore, this may be an alternative to improve these outcomes among individuals in support groups.

Conclusion
The Orientation Group did not alter adherence and self-care among patients with HF in a specialized clinic.
However, it is an important educational strategy in the Rev. Latino-Am. Enfermagem 2017;25:e2982.
Therefore, this study is significant because it demonstrated that well-structured strategies may not achieve the expected goal, but can provide evidence for the construction of more effective interventions.
Multicenter studies with larger samples and in medium-and long-term may produce positive results in the outcomes adherence and self-care through group interventions.