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Internet based vascular risk factor management for patients with clinically manifest vascular disease: randomised controlled trial

BMJ 2012; 344 doi: https://doi.org/10.1136/bmj.e3750 (Published 12 June 2012) Cite this as: BMJ 2012;344:e3750
  1. J W P Vernooij, PhD student, internist in training1,
  2. H A H Kaasjager, internist2,
  3. Y van der Graaf, professor3,
  4. J Wierdsma, nurse practitioner1,
  5. H M H Grandjean, nurse practitioner2,
  6. M M C Hovens, internist2,
  7. G A de Wit, associate professor3,
  8. F L J Visseren, professor1
  9. on behalf of the SMART study group
  1. 1Department of Vascular Medicine, University Medical Center Utrecht, PO Box 85500, 3508 GA Utrecht, Netherlands
  2. 2Department of Internal Medicine, Rijnstate Hospital, Arnhem, Netherlands
  3. 3Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht
  1. Correspondence to: F Visseren F.L.J.Visseren{at}umcutrecht.nl
  • Accepted 20 April 2012

Abstract

Objective To investigate whether an internet based, nurse led vascular risk factor management programme promoting self management on top of usual care is more effective than usual care alone in reducing vascular risk factors in patients with clinically manifest vascular disease.

Design Prospective randomised controlled trial.

Setting Multicentre trial in secondary and tertiary healthcare setting.

Participants 330 patients with a recent clinical manifestation of atherosclerosis in the coronary, cerebral, or peripheral arteries and with at least two treatable risk factors not at goal.

Intervention Personalised website with an overview and actual status of patients’ risk factors and mail communication via the website with a nurse practitioner for 12 months; the intervention combined self management support, monitoring of disease control, and drug treatment.

Main outcome measures The primary endpoint was the relative change in Framingham heart risk score after 1 year. Secondary endpoints were absolute changes in the levels of risk factors and the differences between groups in the change in proportion of patients reaching treatment goals for each risk factor.

Results Participants’ mean age was 59.9 (SD 8.4) years, and most patients (n=246; 75%) were male. After 1 year, the relative change in Framingham heart risk score of the intervention group compared with the usual care group was −14% (95% confidence interval −25% to −2%). At baseline, the Framingham heart risk score was higher in the intervention group than in the usual care group (16.1 (SD 10.6) v 14.0 (10.5)), so the outcome was adjusted for the separate variables of the Framingham heart risk score and for the baseline Framingham heart risk score. This produced a relative change of −12% (−22% to −3%) in Framingham heart risk score for the intervention group compared with the usual care group adjusted for the separate variables of the score and −8% (−18% to 2%) adjusted for the baseline score. Of the individual risk factors, a difference between groups was observed in low density lipoprotein cholesterol (−0.3, −0.5 to −0.1, mmol/L) and smoking (−7.7%, −14.9% to −0.4%). Some other risk factors tended to improve (body mass index, triglycerides, systolic blood pressure, renal function) or tended to worsen (glucose concentration, albuminuria).

Conclusion An internet based, nurse led treatment programme on top of usual care for vascular risk factors had a small effect on lowering vascular risk and on lowering of some vascular risk factors in patients with vascular disease.

Trial registration Clinical trials NCT00785031.

Footnotes

  • We acknowledge the work of the nurse practitioners S Roos, R van de Meijden, M Seger, D van Koten, L Lensen, A Punt, S Hickox, B Sol, and D de Bie; of the research nurses C Joosten and I Klaassen; of the data manager R van Petersen; and of A Geerts and J Maaskant who built the website. The members of the SMART Study Group are: A Algra, Y van der Graaf, D E Grobbee, and G E H M Rutten, Julius Center for Health Sciences and Primary Care; F L J Visseren, Department of Vascular Medicine; F L Moll, Department of Vascular Surgery; L J Kappelle, Department of Neurology; W P Th M Mali, Department of Radiology; and P A F M Doevendans, Department of Cardiology; all University Medical Center Utrecht, Utrecht, Netherlands.

  • Contributors: All authors participated in the design and conduct of the trial. FLJV was the primary investigator together with YG and HAHK. FLJV, YG, and HAHK wrote the study protocol. HAHK, JW, HMHG, MMCH, and JWPV contributed to informing potential study patients and providing care for patients during the study. JWPV wrote the first draft of the manuscript; FLJV, YG, and GAW provided for a thorough revision. FLJV is the guarantor.

  • Funding: This study was financially supported by ZonMw, the Netherlands Organization for Health Research and Development, grant No 80-00702-98-084. The sponsor of this research participated in the design of the study but had no influence over the conduct of the study, the analyses of study data, or the content of this paper.

  • Competing interests: All authors have completed the ICMJE uniform disclosure form at www.icmje.org/coi_disclosure.pdf. The department of FLJV has received grant support from Merck, the Netherlands Organisation for Health Research and Development, and the Catharijne Foundation Utrecht; and speakers’ fees from Merck and AstraZeneca. HAHK has received fees for cardiovascular risk management education programmes from non-profit organisations. JWPV, YG, JW, HMHG, MMCH, and GAW declare: no financial relationships with any companies that might have an interest in the submitted work in the previous three years; and no other relationships or activities that could appear to have influenced the submitted work.

  • Ethical approval: The study was approved by the medical ethics committee of the University Medical Center Utrecht (No 08-119/O) and the local medical ethics committee of the Rijnstate Hospital Arnhem. All participants gave written informed consent.

  • Data sharing: Requests for analyses of de-identified data from this trial should be directed to Frank Visseren (F.L.J.Visseren{at}umcutrecht.nl).

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