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Comparison of the Efficacy of a Diabetes Education Programme for Type 1 Diabetes (PRIMAS) in a Randomised Controlled Trial Setting and the Effectiveness in a Routine Care Setting: Results of a Comparative Effectiveness Study

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  • Dominic Ehrmann
  • Nikola Bergis-Jurgan
  • Thomas Haak
  • Bernhard Kulzer
  • Norbert Hermanns

Abstract

Background: The effectiveness of an intervention in clinical practice is often reduced compared to the efficacy demonstrated in a randomised controlled trial (RCT). In this comparative effectiveness study, the RCT-proven efficacy of a diabetes education programme for type 1 diabetic patients (PRIMAS) was compared to the effectiveness observed in an implementation trial (IT) under routine care conditions. Methods: 75 patients with type 1 diabetes received PRIMAS through an RCT, whereas 179 patients were observed in an implementation trial. Baseline characteristics and treatment outcomes at the 6-month follow-up (improvement of HbA1c, hypoglycaemia problems, and diabetes-related distress) were compared. Results: At baseline, the type 1 diabetic patients in the RCT had a significant longer diabetes duration (18.7±12.3 vs. 13.8±12.7 yrs., p = .005), lower self-efficacy scores (21.9±4.7 vs. 23.7±6.1, p = .02) and a greater number of diabetes complications (0.8±1.3 vs. 0.4±0.9, p = .02). After 6 months, PRIMAS achieved comparable effects under RCT and implementation trial conditions, as demonstrated by improvement in HbA1c (-0.36%±1.1 vs. -0.37±1.2; Δ -0.01, 95% CI -0.33 to 0.31) and hypoglycaemia unawareness (-0.5±1.4 vs. -0.3±1.4; Δ 0.18, 95% CI -0.21 to 0.57). The likelihood of clinical improvement did not depend on the trial setting (RCT vs. IT: OR 1.18, 95% CI 0.60 to 2.33). The participants with worse glycaemic control (OR 1.40, 95% CI 1.02 to 1.92), hypoglycaemia problems (OR 2.13, 95% CI 1.53 to 2.97) or elevated diabetes distress (OR 1.40, 95% CI 1.03 to 1.89) had a better chance of clinical improvement. Conclusions: The effectiveness of PRIMAS under routine care conditions was comparable to the efficacy demonstrated in the RCT. Clinical improvement was independent of the setting in which PRIMAS was evaluated. The PRIMAS education programme for type 1 diabetes can be delivered under conditions of routine care without a loss of effectiveness, compared to its original evaluation in an RCT.

Suggested Citation

  • Dominic Ehrmann & Nikola Bergis-Jurgan & Thomas Haak & Bernhard Kulzer & Norbert Hermanns, 2016. "Comparison of the Efficacy of a Diabetes Education Programme for Type 1 Diabetes (PRIMAS) in a Randomised Controlled Trial Setting and the Effectiveness in a Routine Care Setting: Results of a Compara," PLOS ONE, Public Library of Science, vol. 11(1), pages 1-12, January.
    • Handle: RePEc:plo:pone00:0147581
    DOI: 10.1371/journal.pone.0147581
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    References listed on IDEAS

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    1. Glasgow, R.E. & Lichtenstein, E. & Marcus, A.C., 2003. "Why Don't We See More Translation of Health Promotion Research to Practice? Rethinking the Efficacy-to-Effectiveness Transition," American Journal of Public Health, American Public Health Association, vol. 93(8), pages 1261-1267.
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    1. Citlali Calderon & Lorena Carrete & Jorge Vera-Martínez & María Esther Gloria-Quintero & María del Socorro Romero-Figueroa, 2021. "A Social Marketing Intervention to Improve Treatment Adherence in Patients with Type 1 Diabetes," IJERPH, MDPI, vol. 18(7), pages 1-14, March.

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