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

Lübomira Spassova, Debora Vittore, Dirk W Droste, Norbert Rösch, Lübomira Spassova, Debora Vittore, Dirk W Droste, Norbert Rösch

Abstract

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.

Figures

Fig. 1
Fig. 1
Systolic blood pressure. Significant decrease of systolic blood pressure in IC group
Fig. 2
Fig. 2
LDL. Significant decrease of LDL levels in IC group
Fig. 3
Fig. 3
Triglycerides. Significant decrease of triglyceride levels in IC group

References

    1. World Health Organization (WHO). Cardiovascular diseases (CVDs). Fact sheet 317. 2013. . Accessed 30 April 2015.
    1. Kernan WN, Ovbiagele B, Black HR, Bravata DM, Chimowitz MI, Ezekowitz MD, et al. Guidelines for the prevention of stroke in patients with stroke and transient ischemic attack: a guideline for healthcare professionals from the American Heart Association/American Stroke Association. Stroke J Am Heart Assoc. 2014;45(7):2160–36.
    1. Droste DW, Keipes M. The reduction of stroke risk, risk of myocardial infarction and death by healthy diet and physical activity. Bulletin de la Société des Sciences Médicales du Grand-Duché de Luxembourg. 2013;2:51–62.
    1. Nelson RO, Hayes SC. Theoretical explanations for reactivity in self-monitoring. Behav Modif. 1981;5(1):3–14. doi: 10.1177/014544558151001.
    1. Perk J, De Backer G, Gohlke H, Graham I, Reiner ž, Verschuren M, et al. European Guidelines on cardiovascular disease prevention in clinical practice (version 2012) Eur Heart J. 2012;33:1635–701. doi: 10.1093/eurheartj/ehs092.
    1. Spassova L, Rösch N, Vittore D, Droste DW. CAPSYS: Computer-aided Prevention through Automated Lifestyle Coaching. In: Proceedings of IADIS International Conference on e-Health: 2013. p. 169–73.
    1. Folstein MF, Folstein SE, McHugh PR. Mini-Mental State (a practical method for grading the state of patients for the clinician) J Psychiatr Res. 1975;12(3):189–98. doi: 10.1016/0022-3956(75)90026-6.
    1. Spassova L, Rösch N, Vittore D, Droste DW. Pilot Testing of a Computer-aided Prevention System (CAPSYS) - Study Protocol of a Randomized Controlled Trial. In: CARDIOTECHNIX: 2014. p. 50–4.
    1. Andrade J, Ignaszewski A. Cardiovascular risk assessment: Identification of individuals at increased risk. Br Columbia Med J. 2008;50(5):246–51.
    1. Berry JD, Dyer A, Cai X, Garside DB, Ning H, Thomas A, et al. Lifetime risks of cardiovascular disease. N Engl J Med. 2012;366(4):321–9. doi: 10.1056/NEJMoa1012848.
    1. The EuroQol Group EuroQol - a new facility for the measurement of health-related quality of life. Health Policy. 1990;16(3):199–208. doi: 10.1016/0168-8510(90)90421-9.
    1. Brooke J. Usability Evaluation in Industry. In: Jordan PW, Thomas B, Weerdmeester BA, McClelland AL, editors. London: Taylor & Francis: 1996. p. 189–94.
    1. Sauro J, Lewis JR. Quantifying the user experience - practical statistics for user research. Amsterdam: Elsevier; 2012.
    1. Lewis JR. Predicting Net Promoter Scores from System Usability Scale Scores. . Accessed 30 April 2015.
    1. Reichheld FF. The one number you need to grow. Harv Bus Rev. 2003;81(12):46–54.
    1. Lawes CMM, Bennett DA, Feigin VL, Rodgers A. Blood pressure and stroke - an overview of published reviews. Stroke. 2004;35:1024–33. doi: 10.1161/01.STR.0000116869.64771.5A.
    1. Cholesterol Treatment Trialists’ (CTT) Collaborators Efficacy and safety of cholesterol-lowering treatment: prospective meta-analysis of data from 90 056 participants in 14 randomised trials of statins. The Lancet. 2005;366:1267–78. doi: 10.1016/S0140-6736(05)67394-1.
    1. Varbo A, Nordestgaard BG, Tybjaerg-Hansen A, Schnohr P, Jensen GB, Benn M. Nonfasting triglycerides, cholesterol, and ischemic stroke in the general population. Ann Neurol. 2011;69(4):628–34. doi: 10.1002/ana.22384.
    1. Stuart KL, Wyld B, Bastiaans K, Stocks N, Brinkworth G, Mohr P, et al. A telephone-supported cardiovascular lifestyle programme (CLIP) for lipid reduction and weight loss in general practice patients: a randomised controlled pilot trial. Public Health Nutr. 2014;17(3):640–7. doi: 10.1017/S1368980013000220.
    1. Goode AD, Reeves MM, Eakin EG. Telephone-delivered interventions for physical activity and dietary behavior change: an updated systematic review. Am J Prev Med. 2012;42(1):81–8. doi: 10.1016/j.amepre.2011.08.025.

Source: PubMed

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