Study design: The study was a community quasi-experimental clinical trial, with pre- and post-intervention analysis with two groups of captive population (group A and B), with a 3 months follow-up. The research protocol was approved by the Ethical Committee, Faculty of Medicine, Pontificia Universidad Católica del Ecuador (No. CB. 71 – 2018). The intervention process of both groups was carried out in the Hospital Padre Carollo, Quito - Ecuador.
Sample size: A simple size calculation, based on the study conducted by Al Mazroui and a universe of 753 patients, considering an expected difference of 32% in the intervention group and 18% in the control group. The calculated sample was 148 patients, with a significance of 95% and α error = 5%. The total number of study participants was 159, distributed in two groups, in a non-randomized way, as closely as possible: 79 participants for the Educational strategy group (A) and 80 participants for the Social and family support strategy group (B).
Subjects: Elderly people attended in the outpatient clinic of the Hospital Padre Carollo; 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.
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 (April - July 2018), after which the Morisky Green Levine scale was applied again to the participants of group A and B, categorizing the participants as adherent or no-adherent.
Interventions: Two strategies were designed. Strategy A: EDUCATIONAL: It is based on several techniques, in which both individual and group didactic approaches are carried out. Aimed the patient voluntarily adopting positive attitudes towards medication through the improvement of knowledge about illness, treatment and the importance of adherence.
The technique of group educational sessions was used, using verbal, audiovisual and written aids. Seven educational sessions were completed with an average duration of 30 - 45 minutes each, twice a month. Each session address different topics related to the importance of therapeutic adherence, strengthening in terms of knowledge and skills, regarding chronic disease and its treatment. In each of the workshops given, a record of attendance of the participants was kept. Five was the minimum number of attendances to establish as adequate for the intervention taking account 70% of assistance.
Strategy B: SOCIAL AND FAMILY SUPPORT: Includes interventions aimed to improve adherence through good social support, and mainly involving family members or their peers in the control of the disease to achieve proper management. It does not include Out-of-pocket spending or financial support.
The instrument of family contracts was used, with the aim of educating and agreeing therapeutic actions with the family or it pairs, in order to achieve compliance with the medical indications, with periodic, bi-monthly follow-up to verify the achievement of agreements.
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.
Data analysis: A database was created in Microsoft Excel 2016; statistical analysis was performed using the SPSS software package version 25 and the EpiData software version 3.1. Descriptive analysis, quantitative means and standard deviations were obtained. For bi-varial analysis, Relative Risk (RR) was used as a measure of association and Chi square (X2) as a hypothesis test, A p-Value of <0.05 was considered statistically significant. For quantitative variables the Kolmogorov normality test was applied; using the T-Student for normal distribution, and the Mann-Whitney U for those with asymmetric distribution. For the intragroup and intergroup analysis, the Z test was used to differentiate proportions, as a test of statistical significance.