Danish Evaluation of Your Heart Forecast (DANY): study protocol for a cluster randomised controlled trial on an interactive risk-communication tool aimed at improving adherence of patients with high blood pressure

Anders Elkær Jensen, Jens Søndergaard, Niels Kristian Kjær, Rod Jackson, Jesper Bo Nielsen, Anders Elkær Jensen, Jens Søndergaard, Niels Kristian Kjær, Rod Jackson, Jesper Bo Nielsen

Abstract

Background: To improve communication of risk messages, they must be communicated in a way that is understandable and relevant to the patient. Communicating risk of cardiovascular disease is a complex and individualised task, since the risk itself is a combination of multiple personal risk factors. Raised blood pressure is but one of these risk factors. In Denmark, only one-third of hypertensive patients are adequately treated, with regards to national clinical guidelines. One reason for this problem is low treatment adherence; tools with documented effects for increasing adherence of patients are limited. Our objective is to evaluate the effect of a personalised, interactive and dynamic risk-assessment and risk-communication tool: 'Your Heart Forecast' (YHF) on blood pressure control, primary non-compliance, health literacy and patient empowerment.

Methods: Cluster-randomised controlled trial in general practice. Effect measures are adherence, blood pressure, lipid levels and empowerment at inclusion and after 6 and 12 months. To identify other benefits or possible adverse effects of the intervention, qualitative interviews will be conducted with a subgroup of patients.

Discussion: The investigators will explore effects of Your Heart Forecast on patients' health literacy, adherence, empowerment and blood pressure control. The DANish evaluation of Your heart forecast (DANY) project will be the first to rigorously evaluate effects of YHF in Denmark and to link adherence of hypertensive patients exposed to YHF with the national databases of prescriptions and health services provided.

Trial registration: Clinicaltrials.gov, NCT04058847. Registered on 16 August 2019.

Keywords: CVD risk; Cardiovascular risk; Dynamic; General practice; Heart age; Interactive; Primary care; Protocol; Risk communication; Your Heart Forecast.

Conflict of interest statement

The authors declare that they have no competing interests.

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References

    1. Sørensen K, Pelikan JM, Röthlin F, Ganahl K, Slonska Z, Doyle G, et al. Health literacy in Europe: Comparative results of the European health literacy survey (HLS-EU) Eur J Pub Health. 2015;25:1053–1058. doi: 10.1093/eurpub/ckv043.
    1. Berkman ND, Sheridan SL, Donahue KE, Halpern DJ, Crotty K. Low health literacy and health outcomes: An updated systematic review. Ann Intern Med. 2011;155:97–107. doi: 10.7326/0003-4819-155-2-201107190-00005.
    1. Madsbad S, Larsen ML, Adeler HF, Kryhlmand M, Vestergaard M. Implementering af kliniske vejledninger i almen praksis. Effekten af journal- audit og efteruddannelse. Ugeskr Læger. 2006;168:1640–1645.
    1. College of Danish General Practitioners. Iskæmisk hjerte-kar-sygdom. Clin Guidel. 2018; . Accessed 23 Oct 2019.
    1. Pedersen KMK, Andersen JSJ, Søndergaard J. General practice and primary health care in Denmark. J Am Board Fam Med. 2012;25:S34–S38. doi: 10.3122/jabfm.2012.02.110216.
    1. Regionernes Lønnings-og takstnævn (RLTN) Praktiserende lægers organisation (PLO) Vejledning i anvendelse af Overenskomstens ydelser. 2014. pp. 1–29.
    1. Reuther LØ, Paulsen MS, Andersen M, Schultz-larsen P, Christensen HR, Munck A, et al. Is a targeted intensive intervention effective for improvements in hypertension control? A randomized controlled trial. Fam Pract. 2012;29:626–632. doi: 10.1093/fampra/cms031.
    1. Paulsen MS, Sondergaard J, Reuther L, Larsen PS, Munck AP, Larsen PV, et al. Treatment of 5413 hypertensive patients: A cross-sectional study. Fam Pract. 2011;28:599–607. doi: 10.1093/fampra/cmr027.
    1. Soureti A, Hurling R, Murray P, van Mechelen W, Cobain M. Evaluation of a cardiovascular disease risk assessment tool for the promotion of healthier lifestyles. Eur J Cardiovasc Prev Rehabil. 2010;17:519–523. doi: 10.1097/HJR.0b013e328337ccd3.
    1. Brust-Renck PG, Royer CE, Reyna VF. Communicating Numerical Risk. Rev Hum Factors Ergon. 2013;8:235–276. doi: 10.1177/1557234X13492980.
    1. Wells S, Kerr A, Eadie S, Wiltshire C, Jackson R. “Your heart forecast”: A new approach for describing and communicating cardiovascular risk? Heart. 2010;96:708–713. doi: 10.1136/hrt.2009.191320.
    1. Perestelo-Pérez L, Rivero-Santana A, Boronat M, Sánchez-Afonso JA, Pérez-Ramos J, Montori VM, et al. Effect of the statin choice encounter decision aid in Spanish patients with type 2 diabetes: A randomized trial. Patient Educ Couns. 2016;99:295–299. doi: 10.1016/j.pec.2015.08.032.
    1. De Geest S, Sabaté E. Adherence to long-term therapies: Evidence for action. Eur J Cardiovasc Nurs. 2003;2:323. doi: 10.1016/S1474-5151(03)00091-4.
    1. Prochaska JO, Velicer WF. The transtheoretical model of health behaviour change. Am J Health Promot. 1997;12:38–48. doi: 10.4278/0890-1171-12.1.38.
    1. Maindal HT, Sokolowski I, Vedsted P. Translation, adaptation and validation of the American short form Patient Activation Measure (PAM13) in a Danish version. BMC Public Health. 2009;9:209. doi: 10.1186/1471-2458-9-209.

Source: PubMed

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