Effectiveness of personalized face-to-face and telephone nursing counseling interventions for cardiovascular risk factors: a controlled clinical trial 1

Abstract Objective: to evaluate the effect and gender differences of an innovative intervention involving in-person and telephone nursing counseling to control cardiovascular risk factors (arterial hypertension, dyslipidemia, and overweight), improve health-related quality of life and strengthen self-efficacy and social support in persons using the municipal health centers' cardiovascular health program. Method: a randomized controlled clinical trial involving participants randomized into the intervention group who received traditional consultation plus personalized and telephone nursing counseling for 7 months (n = 53) and the control group (n = 56). The study followed the Consolidated Standards of Reporting Trials Statement. Results: women in the intervention group presented a significant increase in the physical and mental health components compared to the control group, with decreases in weight, abdominal circumference, total cholesterol, low-density lipoprotein cholesterol, and the atherogenic index. The effects attributable to the intervention in the men in the intervention group were increased physical and emotional roles and decreased systolic and diastolic pressure, waist circumference, total cholesterol, low-density lipoprotein cholesterol, atherogenic index, cardiovascular risk factor, and 10-year coronary risk. Conclusion: this intervention is an effective strategy for the control of three cardiovascular risk factors and the improvement of health-related quality of life.


Introduction
The World Health Organization considers noncommunicable diseases (NCDs) to be the leading causes of death and disability worldwide, with cardiovascular diseases being one of the principal NCDs (1) . In Chile, cardiovascular diseases (ischemic heart disease and cerebrovascular disease) are the leading causes of mortality (2) . Additionally, they are also one of the leading causes of disability and impaired quality of life. Hypertension and dyslipidemia are common risk factors in addition to the corresponding lifestyle factors. In Chile, the Cardiovascular Health Program (Programa de Salud Cardiovascular, PSCV) has contributed to an increase in the coverage of people with arterial hypertension and to greater control of arterial pressure (AP) and total cholesterol levels (3) .
However, cardiovascular diseases are still prevalent and cardiovascular risk factors continue to increase (4) , probably due to the way in which the provision of care is presented.
Studies are in agreement that cardiovascular diseases are strongly related to lifestyle and biological risk factors (5) . Therefore, intervention studies measure cardiovascular risk factors such as cholesterol, systolic pressure, body mass index (BMI), diet, and physical activity levels in addition to health-related quality of life (HRQoL), self-efficacy, and social support (6) . Moreover, health care for these diseases should recognize the biological peculiarities of each gender, including differences in cardiovascular risk factors in terms of both prevalence and the way they are presented via different pathophysiological mechanisms in men and women (7) , because these factors influence the specific HRQoL diagnosis of these patients.
Evidence points to the effectiveness of nursing interventions that combine in-person methodology with telephone interventions (8) . Moreover, studies have suggested that it is the responsibility of nurses to implement strategies that contribute to the control of modifiable risk factors for cardiovascular disease (9) and have reported significant improvements in AP, cholesterol, BMI, physical activity, and feeding indicators in the intervention groups (10) .
In Chile, a recent intervention performed by nurses implemented and evaluated a telephone support model for the self-management of chronic disease (apoyo telefónico para el auto-manejo de enfermedad crónica -ATAS) that was initiated in public primary care centers for people with diabetes mellitus type 2 (11) . The results showed that the intervention improved the care of the PSCV controls, stabilized the glycated hemoglobin levels, and decreased the ingestion of unhealthy foods.
The perception of self-efficacy also increased.

Objective
To evaluate the effect and gender differences of an innovative intervention involving in-person and telephone nursing counseling to control cardiovascular risk factors (arterial hypertension, dyslipidemia, and overweight), improve the HRQoL, and strengthen self-efficacy and social support in persons using the cardiovascular health program of the municipal health centers in Concepción.

Methods
Design and type of study: This study was a randomized controlled clinical trial that followed the   years of age) that were the beneficiaries of the public and private health systems of Chile with a Cronbach's alpha of 0.7 (13) . The General Self-Efficacy Scale (14) is A higher score indicates greater general self-efficacy.
The use of this scale in Chile was published in 2010 (15) ; this study indicated that the scale was reliable and Baeza (17) . The Cronbach's alpha reliability coefficient was 0.87. BMI (18) was measured with a scale and stadiometer.
Arterial pressure (19) was measured with a mercury sphygmomanometer and stethoscope. The abdominal circumference was measured using a tape measure with calipers (18) . The lipid profile * was measured using blood were adapted to the characteristics of the Chilean population following a standard procedure (20) . The data corresponding to the application of the instruments were collected by a volunteer from the health field and a senior year nursing student after training by the researchers. The anthropometric measurements, AP,

Intervention
Nursing counseling is understood to be an existential process that focuses on the meaning of the person's health-related life experiences and then becomes a process of dialogue (21) based on effective communication and face-to-face support. From this perspective, feelings, thoughts, and attitudes are explored and expressed to clarify behavior or conduct in relation to a particular health situation and thus aid in decision-making (21) . The counseling has HRQoL as its process in the individual user and the influence on their quality of life (22) . Furthermore, the principles of the theory of Human Becoming were contemplated for the development of this intervention (23) .
A total of 15 sessions were proposed, including The participant will reveal his/her recognition of strategies to benefit his/her HRQoL ‡.

May 28 2 X Less Risk, More Health
The participant will be able to: Understand and identify cardiovascular risk factors. Identify protective factors and strategies to strengthen them.

Hypertension
The participant will be able to understand and identify aspects related to hypertension and recognize it as a disease that must be treated. Strengthening the support network between the user and the nursing professional.

Dyslipidemia
The participant will be able to understand and identify aspects related to dyslipidemia and recognize it as a disease that must be treated. Strengthen the support network between the user and the nursing professional.

Discussion
The data from this study show a predominance of females. This finding is consistent with the results obtained in a Spanish study (25) , which showed that differences between the genders in cardiovascular risk factors, such as arterial hypertension and dyslipidemia, were higher in women, influenced by social class, and accentuated by age. By categorizing the variable of age in completed years into ranges, a higher percentage was observed in the groups of people 55-64 and 45-54 years of age. The largest number of people with hypertension are within these ranges (25) . The prevalence of cardiovascular disease was reported to increase with age; additionally, the risk profile in women was reported to be greater than the risk profile in men (26) . The counseling intervention  (28) . The results obtained concerning the AP levels of the women participating in this study showed the need to prolong the nursing intervention because significant changes were achieved in these variables after 18 months (29) . Unlike the women, the men exhibited significantly decreased systolic pressure and diastolic pressure. This result is consistent with an intervention performed for 6 months aimed at people with excess weight and hypertension where the reduction of AP was significant in men (30) . This finding  (29) . The results obtained in this study showed that implementing personalized and telephone nursing counseling for cardiovascular health can be the basis for preventive interventions for cardiovascular disease and the promotion of health. Despite the positive effects produced by this nursing intervention, we recommend allowing more than seven months to develop this modality of intervention and to establish this type of differentiated nursing care by gender as a continuous process over time because one year is a short time in which to achieve long-term changes and evaluate the results (31) . However, significant changes were achieved in both men and women with the continued development of this intervention that augur greater effects. The intervention was performed in a personalized manner, in-person and by telephone, to respond to the call made to nursing as a discipline for innovative efforts to contribute to the challenge of halting cardiovascular disease through interventions that develop interactive, culturally relevant models and incorporate the specific contexts of each individual in order to achieve behavioral changes in people with chronic diseases (32) .
The limitations in the study are that the instruments used did not quantify the social support provided by the Finally, we concluded that this type of in-person and Vílchez-Barboza V, Paravic Klijn T, Salazar A, Sáez Carrillo K.
telephonic personalized nursing counseling intervention was effective in controlling the cardiovascular risk and improving the health-related quality of life in men and women with hypertension, overweight, and dyslipidemia.