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. 2018 Jul 19;2018(7):CD006732. doi: 10.1002/14651858.CD006732.pub4

NTR6227.

Trial name or title Secondary manifestations of arterial disease ‐ influence of cardiovascular prognosis and treatment effect predictions on patient and physician decision‐making: a three‐armed, blinded, randomized controlled trial
Methods RCT
Participants Inclusion criteria

  • Inclusion in the SMART study (NL45885.041.13)

  • Clinically manifest cardiovascular disease, such as a confirmed diagnosis or strong clinical suspicion of one of the following: coronary artery disease, cerebrovascular disease, peripheral artery disease.

  • Use of statin medication at baseline

  • Between 18 and 80 years of age

  • Rankin Scale < 3


Exclusion criteria

  • Pregnancy

  • Terminal malignancy or short life‐expectancy

  • No follow‐up possible

  • Inability to effectively communicate in Dutch

  • No informed consent (IC) signed

  • Baseline questionnaire not returned
Interventions The three‐arms of this trial are:
Standard‐communication practices only (Control Group)
Standard‐ communication practices plus personalized information on:

  • prediction passport: 10‐year risk of recurrent event and change in absolute risk associated with statin therapy;

  • educational videos;

  • telephone conversation.


Standard‐communication practices plus personalized information on:

  • prediction passport: recurrent cardiovascular event‐free life expectancy and change in recurrent cardiovascular event‐free life‐expectancy associated with statin therapy;

  • educational videos;

  • telephone conversation.
Outcomes Primary outcome

  • Patient experience with decision‐making, measured using the Decisional Conflict Scale (DCS)


Secondary outcomes

  • Prolonged Improved Patient Decision‐Making measured with Decisional Conflict Scale (DCS)

  • Self‐reported medication adherence

  • Patients’ illness perceptions

  • Understanding of therapy‐effects

  • General practitioners’ assessment of the intervention

  • Patient Activation

  • Patient Reported Shared Decision‐Making

  • Patient Perception of Statin Efficacy

  • Quality of Life questionnaire

  • Serum LDL‐c (mmol/L) levels
Starting date March 2017
Contact information Nicole N. M. Jaspers, +31 88 75 556 50, N.E.M.Jaspers@umcutrecht.nl
Notes