Effects of a mobile phone application on medication adherence in homeless patients with type 2 diabetes, hypertension and hypercholesterolemia

Abstract

Background: Long-term adherence to chronic treatments remains exceptionally poor despite current effective therapeutic options. Current evidence suggests this trend is accentuated in

cardiovascular disease chronic treatments, with an estimated non-compliance rate of 50% in high- income countries. Individuals experiencing homelessness have long been known to have a higher

rate of non-adherence than the general population, and it's a growing and aging group, meaning it will see an increase in cardiovascular risk factors and disease in the following decades. There's little research on effective interventions for improving adherence in the homeless, and since new evidence demonstrates that their rate of mobile phone use is quickly aligning with that of the rest of the population, the application of adherence improvement interventions based on new technologies seems to be promising in this field. Objectives: This study aims to use a mobile phone application designed to improve pharmacological treatment compliance, Medisafe, to see its effects on medication adherence of the homeless population with Hypertension, Type 2 Diabetes, and Hypercholesterolemia. It will also look into the intervention effects on clinical attendance and disease control outcomes. Study population: The eligible participants will be male and female aged >18 years registered in the ''La Sopa'' homeless database of Girona, owners of a compatible smartphone, and currently taking medication for their diagnosis of Hypertension, Type 2 Diabetes, or Hypercholesterolemia. Design and methods: This is a randomized, pragmatic, controlled, open-label clinical trial. Each patient will be randomly allocated to one of two possible arms: control arm (receiving usual standard of care) or intervention arm (receiving the Medisafe app intervention along with the usual standard of care). The follow-up period of both groups will be of 12 months, measuring as primary outcome variables objective (Proportion of Days Covered) and subjective (Morisky Medication Adherence Scale) validated measurements of adherence. Secondary clinical outcome variables will be glycated hemoglobin, lipid panel, and blood pressure changes. For medical attendance, the number of clinical visits appointed and attended the year previous to the study will be compared to the ones during the year of the follow-up