title: 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.
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.
authors.affiliation: Research Institute of the Diabetes Academy Mergentheim (FIDAM), Johann Hammer-Str. 24, 97980, Bad Mergentheim, Germany.|Otto-Friedrich-University of Bamberg, Department of Clinical Psychology and Psychotherapy, Bamberg, Germany.
authors.forename: Dominic
authors.initials: D
authors.lastname: Ehrmann
authors.affiliation: Research Institute of the Diabetes Academy Mergentheim (FIDAM), Johann Hammer-Str. 24, 97980, Bad Mergentheim, Germany.
authors.forename: Nikola
authors.initials: N
authors.lastname: Bergis-Jurgan
authors.affiliation: Research Institute of the Diabetes Academy Mergentheim (FIDAM), Johann Hammer-Str. 24, 97980, Bad Mergentheim, Germany.|Diabetes Centre Mergentheim, Diabetes Clinic, Theodor-Klotzbuecher-Str. 12, 97980, Bad Mergentheim, Germany.
authors.forename: Thomas
authors.initials: T
authors.lastname: Haak
authors.affiliation: Research Institute of the Diabetes Academy Mergentheim (FIDAM), Johann Hammer-Str. 24, 97980, Bad Mergentheim, Germany.|Diabetes Centre Mergentheim, Diabetes Clinic, Theodor-Klotzbuecher-Str. 12, 97980, Bad Mergentheim, Germany.|Otto-Friedrich-University of Bamberg, Department of Clinical Psychology and Psychotherapy, Bamberg, Germany.
authors.forename: Bernhard
authors.initials: B
authors.lastname: Kulzer
authors.affiliation: Research Institute of the Diabetes Academy Mergentheim (FIDAM), Johann Hammer-Str. 24, 97980, Bad Mergentheim, Germany.|Diabetes Centre Mergentheim, Diabetes Clinic, Theodor-Klotzbuecher-Str. 12, 97980, Bad Mergentheim, Germany.|Otto-Friedrich-University of Bamberg, Department of Clinical Psychology and Psychotherapy, Bamberg, Germany.
authors.forename: Norbert
authors.initials: N
authors.lastname: Hermanns
mesh_terms: D000328:Adult; D057186:Comparative Effectiveness Research; D003922:Diabetes Mellitus, Type 1 / Q000628:therapy*; D005260:Female; D006442:Glycated Hemoglobin / Q000032:analysis; D006801:Humans; D007003:Hypoglycemia / Q000453:epidemiology / Q000517:prevention & control; D008297:Male; D008875:Middle Aged; D010353:Patient Education as Topic / Q000379:methods; D016896:Treatment Outcome
chemical_list: D006442:Glycated Hemoglobin; C517652:hemoglobin A1c protein, human