Comparison of education group strategies and home visits in type 2 diabetes mellitus: clinical trial 1

ABSTRACT Objective: to compare the adherence and empowerment of patients with type 2 diabetes mellitus for self-care practices and glycemic control in group education strategies and home visits. Method: Clinical trial with ten randomized clusters, performed with 238 patients with type 2 diabetes mellitus distributed in group education, home visit, and control group. Socio-demographic data, glycated hemoglobin and those obtained from the self-care and empowerment questionnaires were collected. Statistical analysis was performed separately by educational strategy. Results: the mean age of the patients was 57.8 years old (SD = 9.4 years old), with a predominantly female participation (66.4%). Both strategies presented similar results regarding adherence to self-care practices and patient empowerment. There was also a reduction in glycated hemoglobin levels; however, only in the education group, the difference presented statistical significance (p <0.001). Conclusion: the strategies were effective; however, group education presented better glycemic control results in relation to the home visit. International registry: NCT02132338 and national: RBR-92j38t in the clinical trials registry.


Introduction
Type 2 diabetes mellitus (DM2) is 90% of the diagnoses of this chronic condition. It is a global health problem due to its high incidence and it is related to inadequate self-care behaviors, such as sedentary lifestyle and inappropriate diet. It is estimated that there are 415 million people in the world aged between 20 and 79 years old who have this condition and the expectation is that this number increases progressively, reaching 642 million in 2040. In Brazil, 14.3 million individuals have this diagnosis (1)(2) .
As a way of collaborating in activities that promote control of this chronic condition, educational strategies such as group education and home visits have presented positive results, aiming at self-care practices in type 2 diabetes mellitus, in the context of adequate nutrition, physical exercise (3), and capacity for problem solving, among other things. When based on the approach of empowerment, through dialogue, patient appreciation, knowledge, and attitudes these strategies are considered effective in promoting and preventing complications (4)(5) .
For this study, self-care was defined as the actions that patients take to lead a healthy lifestyle for their own well-being and health, such as the adoption of concrete behaviors of self-medication, healthy eating, and physical exercise. In this perspective, the empowerment approach supports self-care education in DM2 and stimulates the autonomy of the patient.
Also, the literature indicates that the qualified and intentional involvement of the patient to make decisions is effective in coping with this chronic condition (3)(4)(5) . It is believed that group education and home visits based on an accessible and emancipatory education that favors problematization, the construction of knowledge and skills, as well as the approach to empowerment, can influence behavior change and encourage the patient self-care practices (2,(5)(6) .
However, there is little research that evaluates the effectiveness of educational strategies in primary health care (2,6) . According to previous studies, the existing findings are incipient and heterogeneous regarding educational interventions and study samples, and there is no single standardized program to reach patients with diabetes (7)(8)(9) . Another study comparing educational strategies for this public, proposes the continuity of research of this nature, aiming to understand the threshold between individual and group strategies, considering this process as dynamic and requiring continuous evaluation (10) . Based on the above, the DM2 empowerment education program, developed by the School of Nursing of the Federal University of Minas Gerais (EEUFMG) in primary health care in the city of Divinópolis (MG), used home visit and education group strategies to promote adherence to self-care practices and patient empowerment, aiming at improving glycemic control.
The aforementioned DM2 empowerment program was a 12-month randomized clinical trial that included group education strategies, home visits, and telephone intervention support when needed. These strategies were selected because it was believed that together they could achieve a greater diversity of patients with this chronic condition, promoting the improvement of self-care and glycemic control. The study was conducted by a team of nurse researchers, with the support of a nutritionist and physiotherapist. The patients who participated in the intervention were compared with the patients who received only usual care performed by the health services. However, to date, these strategies have not been analyzed independently by the educational program (2) .
Thus, this study aimed to compare the adherence and empowerment of patients with type 2 diabetes mellitus for self-care practices and glycemic control in group education strategies and home visits.

Method
A clinical trial was conducted with randomized clusters involving 238 patients with type 2 diabetes mellitus treated in ten family health strategies (ESF) of primary health care in the city of Divinópolis (MG), which concluded participation in the diabetes empowerment program, from December 2014 to January 2016.
For the systematization of the educational interventions and the setting of this study, the ten family health strategies (ESF) of the municipality with the highest number of DM2 patients were selected, so each ESF was considered a cluster.
The sample size calculation considered the cluster effect (11) . The value of the intra-class correlation coefficient was estimated at ρ = 0.008, taking previous studies with similar populations as a reference (12)(13) . The sample also used: α = 0.05 (level of significance); ω = 0.90 (test power); d = 1 (standardized effect on the dependent variable), n = 80.9 (average size of clusters), N = 1320 (total population) and k = 10 units of the ESF (clusters). For each large study group (control group -CG and intervention group -IG), a minimum number of 65 patients was determined. Considering 35% as Santos JC, Cortez DN, Macedo MML, Reis EA, Reis IA, Torres HC a value for the friction rate, the minimum number at the beginning of the study should be 100 patients in each group.
Through a lottery carried out in the R (2015) 14) environment, three ESFs were allocated to group education (93 patients), two for the home visit (34 patients) and five ESFs were allocated to the control group (111 patients). After allocation of the ESF to the strategies, the comparison groups were found to be homogeneous in terms of education level and glycated hemoglobin. The division of the five ESFs that would receive the intervention between the home visit and group education considered that the home visit is an educational strategy operationally more expensive than the group education.
Randomization by cluster rather than by individuals was chosen because it allowed a better operationalization of the study and to avoid that the contact between individuals attended by the same team, but belonging to different educational strategies, could bias the results obtained (15) .
The inclusion criteria for participation in the research consisted of having type 2 diabetes mellitus, age guidelines (16) .
Educational strategies focused on adherence and empowerment for self-care in type 2 diabetes mellitus worked through the behavior change protocol and addressed the following items: 1) exploration of the problem; 2) feelings and emotions; 3) feeding, with emphasis on feeding frequency and fiber intake; 4) nutrients (carbohydrates, proteins, fats, vitamins, and minerals); 5) reading of food labels; 6) benefits of physical activity and 7) complications of type 2 diabetes mellitus (12) . The strategies were conducted by health researchers (five nurses, a nutritionist, and a physiotherapist), the ESF professionals collaborated with the availability of the DM2 patient registry, providing and indicating locations for the development of the group, and some as interlocutors between the researcher and the participant in the study. Questionnaires were used to collect sociodemographic data at the initial time (Ti). Also, instruments were used to measure adherence and empowerment for self-care for type 2 diabetes mellitus.
A glycated hemoglobin test was also performed to be used as a clinical indicator. Glycated hemoglobin and the instruments related to adherence and empowerment for self-care were also applied in two moments: at the initial time (Ti), before the beginning of the educational strategies, and at the final time (Tf). The collection was done through semi-structured interviews, conducted by the study researchers themselves in a quiet and reserved environment, and these professionals were also responsible for applying educational strategies.
For the sociodemographic characterization of the patients, a questionnaire was elaborated to collect data of the following variables: gender, categorized as "female" or "male"; age, self-reported, in years; marital status, self-declared and later categorized as "with partner" or "without partner"; education level, self-declared and later categorized into "incomplete elementary school" and "complete elementary school through post-graduation"; occupation, self-declared and later categorized as "active" or "inactive"; and disease time, categorized as "0 to 4 years," "5 to 10 years," or "over 10 years." Self-care adherence was measured through the Self-Care Questionnaire in Diabetes Mellitus (ESM), which consists of eight closed questions about selfcare behaviors related to diet and physical exercise adopted in the seven days prior to the instrument's collection. The ESM questionnaire is parameterized in two ways, depending on the item to be answered: the first form is in relation to the number of days of the week, from zero to seven; the second form used is a scale governed by the occurrence of behavior, categorized as "never," "rarely," "sometimes," "usually," and "always." For analysis, the sum of the alternatives of each item totals one point, and the instrument has a total score of eight points. In items that evaluate the consumption of high fat and sweet foods, the  and high, from 3.8 to 5.0 (18) .

Results
There were 111 comprised the control group (46.6%), 93 (39.1%) from the group education strategy and 34 (14.3%) from the strategy home visit of the 238 diabetes patients who completed the empowerment program. Following the randomized trial guidelines (14) ,   (Table 3).  Adherence to self-care was also analyzed in relation to the time of illness, and the effects of group education and home visit were considered statistically different from zero for patients with longer disease duration and patients with lower disease duration. However, only among the patients with the longer time of illness, a difference was detected between the three groups of the study, with advantage for the home visit.

Discussion
The data of this study show that the strategies of consequently improving glycemic control (20,22) . Participating patients demonstrated that they were actively involved in the decision-making process, building and developing goals to achieve satisfactory results in controlling diabetes.
These results also corroborate those presented in an educational program in diabetes, which, due mainly to the interaction and participation of the patients, obtained effective results in improving self-care practices and metabolic control of type 2 diabetes mellitus, confirming the results of this study (27) . In a complementary way, there is a study about the empowerment in adherence to the therapeutic regimen in people with diabetes, carried out in Portugal. In this study, it was found that the majority of participants with a high level of empowerment obtained greater therapeutic adherence to the treatment of diabetes. In other words, the greater the incentive to patient empowerment, the greater will be their adherence to self-care practices (25) .
According to the authors, educational strategies based on empowerment that aim at patient involvement and their co-responsibility for self-care may reinforce the control of this chronic condition (27). Once empowered, patients' behavioral changes, propitiated by this approach, can extend to subsequent years, ensuring continuity of care for this condition (28) .
Another study conducted with 295 people with type 2 diabetes mellitus in Taiwan, demonstrated that using the empowerment approach to manage this condition can improve knowledge and self-efficacy of the patient that is a belief in their ability to good therapeutic behavior. So, by working with this variable, it is possible to modify life habits, culminating in the improvement of glycemic control (29) .
Regarding adherence to self-care, the ESM questionnaire identified an improvement in both educational strategies, through the adoption of positive behaviors for the control of type 2 diabetes mellitus, such as healthy eating and physical exercise. These results are in agreement with studies that point to group education and home visit as important strategies in the self-care awareness of this condition (29) . However, there are also studies that point out that for these educational strategies to be effective, a commitment of the patient, as well as a proactive and prepared team, is important (8) .
Besides the variables mentioned above, glycated hemoglobin was also an important indicator of self-care behaviors mediated by the empowerment approach. In this study, there was a significant decrease in HbA1c in the group education strategy. However, the home visit did not improve this indicator, which may be related to the fact that contact time was lower than that of group education. In a study about the contact time in educational practices in type 2 diabetes mellitus, it is suggested that educational strategies that total 12 hours of duration are more effective in achieving better results (30) .
The control group that received the traditional  (31) . This new context may have contributed to the reflection of professionals on the need to rethink the educational strategies developed (32) .
When facing publications of the same nature, this study demonstrated the importance of well-structured educational strategies for both group education and home viewing. Moreover, the way in which the methodology of educational strategies was delineated allows the replication of these strategies in the real conformation of primary health care to Brazilian health (4,(9)(10) .
Santos JC, Cortez DN, Macedo MML, Reis EA, Reis IA, Torres HC One limitation of this study is that the cognitive and/or intellectual capacity of the patients was not considered, even if they were participants with a wide age group. Also, the need to make the comparisons considering disease time, due to the inhomogeneity of the groups in relation to this variable, reduced the sample sizes in some cases and, consequently, the power of the statistical tests used.
Another limitation that may have occurred is in the place where the study was performed, a city in the interior of Minas Gerais, which has very own sociodemographic characteristics. In the future, it is suggested to replicate this study in a multicentric way or in metropolitan regions.

Conclusion
The strategies were effective, and group education presented better results in relation to the home visit for adherence and the empowerment of the patient with type 2 diabetes mellitus for self-care and glycemic control practices.