Adherence in elderly patients with NCDs: Which is the best, educational or social support? A comparative study in Ecuador

Background: Adherence to treatment is one of the mainstays of non-communicable diseases adequate control. Non – adherence can affect several aspects to both the patient and the health system. For this reason, it is important to have intervention strategies available to prevent detachment and improve adherence to treatment. The objective of this study is to evaluate the effectiveness of the educational strategy compared with the social and family support for the improvement of adherence in patients with chronic noncommunicable diseases. Methods: A quasi-experimental study was conducted in 159 participants with diagnosis of arterial hypertension or/and diabetes mellitus type 2 plus polypharmacy. Participants were divided in two groups and strategies: Group A: educational (n = 79) and Group B social/family support (n = 80), follow up three months for each group. For group "A", informative group workshops were assigned; while for group "B" therapeutic agreements were established. Adherence to treatment pre- and post-intervention were evaluated using the four item Morisky Green Levine scale of public domain. At the end of the intervention period, an intra and intergroup analysis were performed and a Z test for difference in proportions was applied; the RR was used as a measure of association, and Chi2 as a measure of significance. Results: A total of 152 patients complete the intervention. In group A, pre-intervention non-adherence was 58.2%, post-intervention of 45.3% and final reduction of the failure was 12.9% (p<0,001). In group B, pre-intervention non-adherence was 55%, post-intervention 46.8%, and final reduction of adherence failure of 8.2%, (p> 0.05). Statistically significant difference was obtained between the decrease in the failure reached after the application of the educational strategy compared to social / family support strategy (p = 0.001). Conclusions: Educational strategy is more effective than social/family support strategy, to reduce the failure of therapeutic adherence. There was not association of These results are comparable with the prospective, interventional study by Adepu et al. conducted in the Medicine Outpatient Department, in which it obtained a 15% decrease in adherence failure in the intervention

sociodemographic factors and adherence to treatment.

Background
By 2001 adherence was defined by World Health Organization (WHO) as: "the extent to which the patient follows medical instructions". This definition presents some difficulties; the term "medical" does not describe the magnitude of the interventions that need to be used to treat chronic diseases. On the other hand, the word "instructions" leads the patient to be a passive actor receiving guidelines and advice, when must be an active entity throughout the treatment. Finally in 2003, WHO defined adherence as "the extent to which a person's behavior (taking medication, following a diet and/or making changes in lifestyle) corresponds to the recommendations agreed upon by a health care provider" using the previous concepts proposed by Haynes and Rand.[1,2,3] Adherence behavior is the most important factor to assess the effectiveness of the prescribed therapeutic regimen in a patient with a chronic disease. In 2017, WHO reports that in the European Region is the most affected by noncommunicable diseases, these conditions account for an estimated 86% of the deaths and 77% of the disease and some of them as a result of non-adherence. In Europe is estimated that 20% to 30% of patients do not adhere to therapeutic short regimens, and when long-term medication is prescribed, 50% of patient are non-adherents. [4] Some researchers have studied the extent of non-adherence among certain medical conditions, indicating that only 51% of hypertension patients at the United States adhere to their prescribed drug treatment regimens. Also, nearly a half of all adults have at least one chronic disease, and the rate of non-adherence varies from 25% to 50%, and it extends according to the characteristics of the patient, the disease and insurance coverage. [5,6] Other interesting findings have been reported in Asia where the adherence percentage fluctuates according to the age found in diabetic patients: elderly group (28.1%), middleaged group (36.2%) and younger group (51.8%). Moreover, the mean adherence rate in people with hypertension on this population ranges from 50 to 70%. [7,8] In a study conducted in 7 cities in Latin America, adherence failure percentage was found that ranges from 30 to 40% in chronic diseases, such as arterial hypertension, diabetes and dyslipidemia. [9] However, in Ecuador the adherence average does not differ from another population, being of 51.7% reported in some clinical studies, which indicates that 1 out of 2 patients do not take the medication in the way that is considered appropriate. [10] Adequate control of the most prevalent chronic diseases has become one of the main determinants for prevention of complications and premature deaths. It is estimated that approximately 40.8% of a certain captive population of diabetic patients in Ecuador has achieved good glycemic control, with an average glycosylated hemoglobin of 7.8 ± 1.7%. [11] Only 51.1% of the hypertensive population has an adequate blood pressure control level and more than two thirds of both diabetic and hypertensive population maintain inadequate control of their disease. [12] Therefore, the main objective of the implementation of one or several adherence improvement strategies is to achieve therapeutic adherence to improve or eliminate unhealthy behaviors with the purpose of obtaining advantages in terms of quality of life and propose an impact favorable on the reduction of health costs. [6,13] There are several studies that have demonstrated the effectiveness of interventions on adherence and the impact on the control and cost of the disease and its determinants. [14,15,16] The improvement of therapeutic adherence should be an intermediate objective in the care of patients and not as a final goal. Despite the importance directed to the prevention and improvement of adherence, the final goal of medical practice should always be the adequate control of the disease, rehabilitation or as far as possible cure of the process, to provide a favorable quality of life of the patients.
The main objective of this study was to evaluate the effectiveness of the educational strategy compare with strategy of social and family support for the reduction of therapeutic adherence failure in elderly patients with hypertension or/and diabetes mellitus type 2, and polypharmacy. who met the inclusion criteria: age over 65 years, diagnosis of diabetes and / or hypertension plus polypharmacy (use of 3 or more drugs); that did not present exclusion criteria: severe physical and/or cognitive impairment that prevents participation in educational workshops and follow-up meetings and/or clinical complications of the disease: diabetic decompensation, hypertensive emergency that warrants hospital admission.

Methods
All subjects included in the study accepted their voluntary participation through informed consent.
Procedure for collecting information: A survey was used to obtain sociodemographic data, medical history, social support network. For the evaluation of adherence, the four item Morisky Green Levine scale, validated in 1986 and of public domain was used. It has a sensitivity of 93% and specificity of 53%, in detection of therapeutic noncompliance. [17] It is a validated short questionnaire in patients with chronic diseases. Due to its sensitivity and the affordability of its practice, this test has become an easy tool to use in ambulatory level of care. [18,19] An intervention was designated for each group during a planned time of three months

Tracing:
Intervention group A: The workshops were given every 2 weeks, completing a total of 7 workshops. In order to monitor the progress of the patient within the program, their condition and health status, weekly telephone calls were made and a total of 3 medical appointments were completed. Those who did not complete the minimum of 5 assistances were excluded from the study.
Intervention group B: It was carried out through weekly telephone contacts and three medical appointments during the whole process, in order to monitor the disease, assess the progress and fulfillment of the family contract. After completing the planned intervention time, those participants from whom the contact was lost were excluded from the study and therefore verification of compliance with the therapeutic contract.
During the follow-up period, no new rescue interventions were performed to improve adherence; only the advances made in each group were evaluated.

Results
A total of 159 participants from 231 met the inclusion criteria and were divided into two groups: group A (n = 79) and group B (n = 80). Throughout the intervention, losses were registered in both groups: 7 patients from group A and 4 from group B. Figure 1 illustrate the selection and distribution of participants during the investigation. The sociodemographic and clinic characteristics of both groups are presented in Table 1. The statistical analysis showed that the groups were heterogeneous in relation to gender, previous diagnosis, time of diagnosis of the disease and number of doses of medications per day, with p> 0.05; however, in these variables no significant risk association was found that influences the final adherence result.  Table 2 shows the calculation of the difference in proportions of the therapeutic adherence failure for each one of the groups through the application of a Z test, during the pre-and post-intervention; 12.9% in group A (p = 0.15) and 8.3% in group B, without statistically significant differences for both groups (p = 0.38).  (CI 2.9 -43.5) p 0.000). (Table 3)

Discussion
Adherence represents a great challenge for the health system, due to the increase in the incidence of chronic noncommunicable diseases in the elderly population, being this one the most susceptible to suffer the consequences of poor adherence. The results of this study allow to demonstrate that the timely implementation of an educational strategy contributes in the long term to the improvement of adherence; since it optimizes the knowledge about illness and treatment, generating an individual empowerment.
More than 50% of the study participants do not adhere to the prescribed treatment (58.2% group A and 55% group B). The lack of adherence to therapeutic treatment is one of the situations that is manifested as usual in clinical practice, as shown by several studies, reporting a failure of adherence between 40% -50% and in some cases even greater than 55%. [20,21,22] Educational strategy decreased the failure rate by 12. Previous systematic reviews have shown that the highest percentage of adherence failure reduction linked to an educational intervention strategy is 45.5% and the lowest is 4,8%.
In the following Table 4 a comparison is made between the studies carried out on the measurement of adherence.
Several studies have attempted to demonstrate the beneficial effect of implementing strategies for the improvement of therapeutic adherence, either as a single strategy or as a combination of these; mainly using techniques of educational reinforcement, counseling (including motivational interview or cognitive-behavioral therapy), and additional support from family or partners. [14,15,16]  showing that low social support is a risk factor for lack of adherence to therapeutic indications and contributes to an increase in cardiovascular risk. [31] Conclusions Present study was able to demonstrate that the educational strategy turned out to be more effective than social and family support strategy, to decrease the non-adherence. To achieve improvements in adherence, is required an interdisciplinary health team and a chronic care model within the local health system to deal effectively with noncommunicable conditions; being the family doctor who must lead the application of strategies that encourage a good adherence; with an integrating vision, that includes all the actors: patient, family and medical team in the process. To diminish the own complications derived from the disease and the sanitary cost, being necessary, to implement available strategies (educational, behavioral, therapeutic, social, combined) to improve or maintain an adequate adherence to the treatment, being a combination of these, the best option.

Limitations
The present study did not consider the out of pocket or financial support for medication of each one of patients. However, access to medicines is not enough to reduce the burden of chronic diseases, according to the World Health Organization.

Consent for publication: Not applicable.
Availability of data and materials: The material and statistical data used for the preparation of this study are available from the corresponding author upon reasonable request.

Funding. Not applicable
Competing of interest: The authors report they have no conflicts of interest with regards to the publication of this manuscript.  Selection and distribution of participants.