Summary
Background
We evaluated the disease management programme (DMP) “Therapie Aktiv” for diabetes mellitus type 2 during the first year of implementation in a cluster-randomised controlled trial (RCT), which revealed an improvement of process quality, but only insignificant effects on HbA1c. To further analyse the effects of the DMP we followed up participants of the RCT for another year.
Methods
After completion of the RCT, the study was continued as an open observational trial. By patient’s choice, three groups were formed. Group 1 (DMP/DMP): interventions of the RCT (DMP), who remained in the DMP; group 2 (Control/DMP): controls of the RCT (usual care), who participated in the DMP during the second year; group 3 (Control/Control): controls of the RCT (usual care), who remained as controls. Primary outcome measure: HbA1c. Secondary outcome measures: BMI, lipids, blood pressure and measures of process quality.
Results
Only 801 of 1,489 RCT participants completed the study (53.8 %). Group 1: n = 355; group 2: n = 335; group 3: n = 111. After 2 years, pre-post-analysis revealed a significant reduction of HbA1c (0.37 %, p < 0.001) in both DMP groups, and a reduction of only 0.03 % (p = 0.975) in the control group. However, the difference between the groups was not significant (p = 0.065). There was a significant improvement of process quality in the DMP groups compared with controls.
Conclusion
The DMP clearly enhances process quality. Furthermore, the DMP yields a reduction of HbA1c within groups after 2 years, but significance is lost in between-group analysis. We conclude that the DMP has only a minor effect on metabolic control.
Zusammenfassung
Grundlagen
Im ersten Jahr der Implementierung haben wir das Disease Management Programm (DMP) „Therapie Aktiv“ für Diabetes mellitus Typ 2 im Rahmen einer cluster-randomisierten kontrollierten Studie (RCT) evaluiert. Es zeigte sich eine deutliche Verbesserung der Prozessqualität, jedoch keine signifikanten Effekte hinsichtlich HbA1c Reduktion. Um die Effektivität des DMPs über einen längeren Zeitraum zu untersuchen, beobachteten wir die RCT-Teilnehmer ein weiteres Jahr.
Methodik
Nach Beendigung des RCT wurde die Studie als offene Beobachtungsstudie weitergeführt. Basierend auf Patientenwahl ergaben sich 3 Gruppen: Gruppe 1 (DMP/DMP): Interventionsteilnehmer des RCT (DMP), die im DMP blieben; Gruppe 2 (Kontrolle/DMP): Kontrollen des RCT (Usual Care), die im zweiten Jahr ins DMP eintraten; Gruppe 3 (Kontrolle/ Kontrolle): Kontrollen des RCT (Usual Care), die als Kontrollen in der Studie blieben. Primäres Zielkriterium: HbA1c. Sekundäre Zielkriterien: BMI, Lipide, Blutdruck und Prozessqualitätsparameter.
Ergebnisse
Daten von lediglich 801 der 1.489 RCT-Teilnehmer (53,8%) konnten nach 2 Jahren analysiert werden. Gruppe 1: n = 355; Gruppe 2: n = 335; Gruppe 3: n = 111. Die Vorher-Nachher-Analyse ergab eine signifikante Reduktion des HbA1c (0,37 %, p < 0,001) in beiden DMP Gruppen, und lediglich eine Reduktion von 0,03 % (p = 0,975) in der Kontrollgruppe. Jedoch waren die Unterschiede zwischen den Gruppen nicht signifikant (p = 0,065). In beiden DMP Gruppen fanden sich, verglichen mit der Kontrollgruppe, signifikante Verbesserungen der Prozessqualität.
Schlussfolgerung
Die Prozessqualität wird durch das DMP deutlich verbessert. Weiters führt das DMP zu einer signifikanten HbA1c Reduktion innerhalb der Gruppe, jedoch geht die Signifikanz im Vergleich zwischen den Gruppen verloren. Wir schließen daraus, dass das DMP lediglich geringe Effekte auf die metabolische Kontrolle hat.
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Flamm, M., Panisch, S., Winkler, H. et al. Effectiveness of the Austrian disease management programme “Therapie Aktiv” for type 2 diabetes regarding the improvement of metabolic control, risk profile and guideline adherence: 2 years of follow up. Wien Klin Wochenschr 124, 639–646 (2012). https://doi.org/10.1007/s00508-012-0226-x
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DOI: https://doi.org/10.1007/s00508-012-0226-x