Comparison of the effect of pillbox reminders and SMS on the web on the of adherence patients with heart failure to the medication regimen: a randomized controlled trial

Abstract

Abstract: Background and purpose: heart failure is the last line of all cardiovascular diseases. Non-adherence to the medication regimen in this disease can lead to re-hospitalization, increased need for medical interventions, illness, mortality and increase in health care costs. In this regard, many effective interventions have been presented in order to improve adherence to the medication regimen in this group of patients. But there is still no consensus on the most effective and least expensive methods. Therefore, in a quantitative approach, we decided to conduct a study with the aim of comparing the effect of reminders using the pillbox and SMS on the web on the adherence of heart failure patients with the medication regimen. Materials and methods: In this parallel randomized controlled trial, 189 heart failure patients were eligible with inclusion criteria: at least 18 years old, ability to read and write in Farsi, primary diagnosis of chronic heart failure confirmed by a cardiologist, absence of cognitive problems based on AMT cognitive level status questionnaire, mobile phone availability and the ability to use it, heart failure class 2 and 3 based on the New York heart function classification scale for 3 months or more based on the diagnosis of the attending physician from Shahid Madani Hospital, Tabriz, Ward were studied. The available samples are randomized and using Random Allocation Software (RAS) with blocks of size 6 and 9 and allocation ratio 1:1:1 in three control groups and the first intervention group (pillbox reminder) and the second intervention group. (Text message reminder system on the web) were placed. In order to hide the allocation, the same closed opaque envelopes were used, and the envelopes were numbered from 1 to 189, and the type of intervention based on the random sequence of allocation was written on paper and placed inside the envelopes in order. The production of the allocation sequence and the preparation of envelopes based on it was done by a person not involved in the research. The control group (n=63) received routine follow-up as well as a simple medicine box to store monthly medicines, the first intervention group (n=63) received four weekly pillboxes and the second intervention group (n=63) received text messages based on the medication regimen of the patients and They also received a simple medicine box to store monthly medicines for 3 months. At the end of each month, the patients of all three groups were called and their adherence to drug treatment was measured using the MARS medication adherence questionnaire and the number of remaining drugs in the simple medicine box in the control and the second intervention groups and the number of remaining drugs in the pillbox in the first intervention group and the hospitalization rate due to heart failure was assessed through self-questioning. Data analysis was performed using non-parametric Kruskal-Wallis statistical tests and ANOVA and Repeated measure ANOVA software version 16 at a significance level of less than 0.05. Results: The subjects of the study in terms of basic characteristics other than age (p=0.028), economic status (p=0.001), history of diuretic drug use (p=0.038), history of sleep apnea (p=0.001), history of myocardial infarction (p=0.016), history of high blood pressure (p=0.041), history of diabetes (p=0.024) and number of daily medications (p=0.036) were the same. In terms of the average score of medication adherences, the interaction of time with the group was significant (p<0.05). After completing the intervention, medication adherence in the pillbox group (mean difference=1.33, 95% confidence interval=0.95 to 1.72, P<0.001) and texting (mean difference=1.32, 95% interval confidence = 0.93 to 1.72, P<0.001) was significantly higher than the control group. But medication adherence in SMS group wasnot significant compared to pillbox (mean difference = -0.01, 95% confidence interval = -0.39 to 0.37, P = 952). There was a significant difference between the three intervention groups in the hospitalization rate only at the end of the first month after the intervention (p=0.016). So, the hospitalization rate in SMS group was lower compared to another group. Discussion and conclusion: The results of this study showed that although the medication adherence was higher in the intervention groups compared to the control group, sending short messages on the web wasnot preferable to using a pillbox in reducing the rate of unintentional medication non-adherence in heart failure patients. And also, sending text messages in comparison to the pillbox led to a decrease in the hospitalizations rate only at the end of the first month. It is recommended to conduct further studies with a larger sample size, a longer intervention period, and sampling from several centers.