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

PloS One
Dominic EhrmannNorbert Hermanns

Abstract

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. 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. 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...Continue Reading

References

Aug 19, 1995·BMJ : British Medical Journal·D G Altman, J M Bland
Jan 1, 1995·Diabetes Care·M M Funnell, L B Haas
Aug 1, 1997·Diabetologia·S BottI Mühlhauser
Jun 7, 2000·Diabetes Care·R M AndersonD G Marrero
Sep 15, 2000·BMJ : British Medical Journal·M CampbellP Tyrer
May 3, 2002·American Journal of Preventive Medicine·Susan L NorrisDavid McCulloch
Oct 26, 2002·BMJ : British Medical Journal·Edward H Wagner, Trish Groves
Dec 19, 2002·Diabetologia·I Mühlhauser, M Berger
Jan 20, 2004·Patient Education and Counseling·Shelley E EllisTom A Elasy
Mar 1, 2005·Diabetes Care·William H PolonskyRichard A Jackson
Jul 2, 2009·The New England Journal of Medicine·John K Iglehart
Jun 24, 2010·Clinical Trials : Journal of the Society for Clinical Trials·Douglas P KielClinton T Rubin
Jan 4, 2012·Diabetes Care·Martha M FunnellMichael A Weiss
Feb 13, 2013·Diabetes Research and Clinical Practice·Sean F DinneenUNKNOWN Irish DAFNE Study Group
Nov 12, 2013·Diabetes Research and Clinical Practice·Norbert HermannsThomas Haak

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Citations

May 5, 2016·Current Medical Research and Opinion·S FranchiniA Blasetti
Apr 4, 2021·International Journal of Environmental Research and Public Health·Citlali CalderonMaría Del Socorro Romero-Figueroa

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Software Mentioned

PRIMAS
DAFNE
SYSTAT

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