The present study was a single-blind randomized controlled trial with code registered in Iranian clinical trial site (IRCT20200407046979N1) that conducted on patients with epilepsy aged between 18 and 50 years old referred to Shiraz Namazi Hospital in southern Iran, in 2020-2021. The sample size was considered 46 individuals with first type error of 0.05 and 80% power and using study by Kazemi Majd et al. (2017)(26). The sample size was calculated with following sample size formula. Considering a maximum of 20% of patients’ loss during the study, 5 patients were added to each group.
$$n={\left({z}_{\frac{\alpha }{2}}+{z}_{\beta }\right)}^{2}\left(\frac{{\sigma }_{1}^{2}+{\sigma }_{1}^{2}}{{(\mu -{\mu }_{0)}}^{2}}\right)={\left(1.96+1.64\right)}^{2}\left(\frac{{1.33}^{2}+{1.43}^{2}}{{\left(6.69-5.57\right)}^{2}}\right)\approx 23$$
\(\alpha =0.05 ,{z}_{\frac{\alpha }{2}}=1.96\) \(\beta =0.1 ,{z}_{\beta }=1.64\)
Inclusion criteria in this study were the followings: definitive diagnosis of epilepsy, age range of 18 to 50 years old, having at least one seizure during the last trimester, having of at least 2 years of epilepsy, treated with at least one anticonvulsant drug, and willingness and ability to learn using WhatsApp application. The exclusion criteria included the exacerbation of the disease and incidence of disability or life-threatening conditions of patients, refractory epilepsy, having a specific physical illness (heart disease, etc.) and history of mental illness (depression, etc.) or suffering from an acute illness during the study period, a lack of willingness and consent to participate or to continue the study, and participating in a disease self-management training program during past 6 months. Sampling method used for the patients was simple random. The list of epilepsy patients referred to Namazi Hospital affiliated to Shiraz University of Medical Sciences was prepared and then the eligible patients were randomly selected using lottery. At the next stage, the patients were randomly divided into two intervention groups (28 patients) and a control group (28 patients) using random allocation software(27) (figure 1). Afterward, demographic information form and Morisky medication adherence scale were used to collect data. The demographic questionnaire included information on age, sex, level of education, marital status, number of seizures in the last 3 months, type of seizure, and family history of epilepsy.
Morisky Medication Adherence Scale (MMAS-8): This questionnaire was firstly developed by Morisky, Ang, Kruselwood, and Ward (2008) (28). This questionnaire has 2 items, including seven two-choice questions and one four-choice question. In terms of the tool’s structure, this questionnaire has no subscales and is a single factor. The method of scoring the questionnaire is that this questionnaire has 7 questions in the form of a closed answer with a two-point Likert scale (yes and no), which are assigned a score between 0 and 8, respectively. Of note, questions 1 and 2 are scored reversely. The first seven questions are graded with zero and One and the eighth question is graded with 0.25, 0.5, 0.75, and 1, which has a score less than six according to this questionnaire. A low level of adherence indicates a score of six to less than eight, an average level of adherence and a score of eight indicates a high level of adherence of the patient. In Iran, the validation of the Morisky scale was examined negarandeh and et al. (2013). Its reliability was also confirmed using retesting and internal consistency methods, so that reliability was reported as 0.8 using Cronbach’s alpha coefficient (29).
Implementation
At first, the questionnaire was designed in a web environment and the link of the online Questionnaires before and after the intervention was sent to the patients through the WhatsApp application. Thereafter, the Model 5A self-management program was applied for the intervention group. The implementation of the program for patients during two stages of familiarization with the disease and implementation of medication adherence skills based on the 5A care model (which includes 5 stages) for the patients in the intervention group, training sessions by the researcher (the MA nursing student), 5 sessions per week (Fridays 12:00 o’clock – 14:00 afternoon), and during the week in the form of questions and answers on WhatsApp personal page, were used for the first 4 stages of the 5A self-management model as well as the last stage of this model, which was implemented by the patient himself for a two-month period under the researcher’s weekly supervision and follow-up. The 5A self-management program for the intervention group was implemented as follows: The first stage of the Assess: This stage was performed in the first and second weeks.
In this phase, the person’s condition in terms of disease history, use of drugs, questions on the reason for not taking drugs, sleep and nutrition status and activity, and finally filling out the electronic scale of medication adherence and acquisition Conscious consent were obtained. The second stage of Advice: This stage was performed in the third week, and the intervention was done to discuss about the risks and side effects of not taking drugs and consequently the increased seizures, the benefits of timely use of drugs, and its effect on reducing seizures. The third stage of the Agree: This stage was done in the fourth week and both the patient and the researcher agreed on changing the behavior and re-informing about the timely use of the prescribed drug and its benefits. Fourth stage of Assist: This stage was done in the fifth week, the emphasis of which was on the timely use of medicine, the benefits of taking medicine, and reviewing the content of the previous sessions. Fifth stage of Arrange: This stage was performed in the sixth to eighth weeks. Additionally, in the sixth week, the performance of medication adherence was monitored, and the drug registration form was completed at the end of each session by phone and SMS for each patient. In the seventh week, giving general information on epilepsy and re-emphasizing on the timely use of drugs and reviewing the content of previous sessions. Finally, in the eighth week, the study was completed and the questionnaires were filled after the intervention by the patients.
Subsequently, all the patients in both intervention and control groups completed the electronic questionnaire of demographic information, the electronic scale of Morisky medication adherence by passing two months from the intervention.
Data Analysis
In order to achieve the objectives of this research, the obtained data were analyzed using descriptive statistics and inferential statistics and data collected by SPSS software version 21. Wilcoxon test was then used for intra-group comparison and Mann-Whitney test was used for intergroup comparison. Significance level was considered at 0.05.