Randomised controlled trial to evaluate the efficacy and usability of a computerised phone-based lifestyle coaching system for primary and secondary prevention of stroke

BACKGROUND: One of the most effective current approaches to preventing stroke events is the reduction of lifestyle risk factors, such as unhealthy diet, physical inactivity and smoking. In this study, we assessed the efficacy and usability of the phone-based Computer-aided Prevention System (CAPSYS) in supporting the reduction of lifestyle-related risk factors. METHODS: A single-centre two-arm clinical trial was performed between January 2013 and February 2014, based on individual follow-up periods of six months with 94 patients at high risk of stroke, randomly assigned to an intervention group (IC: 48; advised to use the CAPSYS system) or a standard care group (SC: 46). Study parameters, such as blood pressure, blood values (HDL, LDL, HbA1c, glycaemia and triglycerides), weight, height, physical activity as well as nutrition and smoking habits were captured through questionnaires and medical records at baseline and post-intervention and analysed to detect significant changes. The usability of the intervention was assessed based on the standardised System Usability Scale (SUS) complemented by a more system-specific user satisfaction and feedback questionnaire. RESULTS: The statistical evaluation of primary measures revealed significant decreases of systolic blood pressure (mean of the differences = –9 mmHg; p = 0.03; 95 % CI = [–17.29, –0.71]), LDL (pseudo-median of the differences = –7.9 mg/dl; p = 0.04; 95 % CI = [–18.5, –0.5]) and triglyceride values (pseudo-median of the differences = –12.5 mg/dl; p = 0.04; 95 % CI = [–26, –0.5]) in the intervention group, while no such changes could be observed in the control group. Furthermore, we detected a statistically significant increase in self-reported fruit and vegetable consumption (pseudo-median of the differences = 5.4 servings/week; p = 0.04; 95 % CI = [0.5, 10.5]) and a decrease in sweets consumption (pseudo-median of the differences = –2 servings/week; p = 0.04; 95 % CI = [–4, –0.00001]) in the intervention group. The usability assessment showed that the CAPSYS system was, in general, highly accepted by the users (average SUS score: 80.1). CONCLUSIONS: The study provided encouraging results indicating that a computerised phone-based lifestyle coaching system, such as CAPSYS, can support the usual treatment in reducing cerebro-cardiovascular risk factors and that such an approach is well applicable in practice. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT02444715