The impact of a disease management programme for type 2 diabetes on health-related quality of life: multilevel analysis of a cluster-randomised controlled trial

Sigrid Panisch; Tim Johansson; Maria Flamm; Henrike Winkler; Raimund Weitgasser; Andreas C Sönnichsen

doi:10.1186/s13098-018-0330-9

The impact of a disease management programme for type 2 diabetes on health-related quality of life: multilevel analysis of a cluster-randomised controlled trial

Diabetol Metab Syndr. 2018 Apr 10:10:28. doi: 10.1186/s13098-018-0330-9. eCollection 2018.

Authors

Sigrid Panisch^#¹, Tim Johansson^#², Maria Flamm², Henrike Winkler³, Raimund Weitgasser^{4

5}, Andreas C Sönnichsen^{6

7}

Affiliations

¹ 1Department of Mathematics, University of Salzburg, Hellbrunner Str. 34, 5020 Salzburg, Austria.
² 2Institute of General Practice, Family Medicine and Preventive Medicine, Paracelsus Medical University, Salzburg, Strubergasse 21, 5020 Salzburg, Austria.
³ 3Paris Lodron University, Kapitelgasse 4-6, 5020 Salzburg, Austria.
⁴ Department of Internal Medicine, Wehrle-Diakonissen Hospital, Haydnstrasse 18, 5020 Salzburg, Austria.
⁵ 5Paracelsus Medical University, Strubergasse 21, 5020 Salzburg, Austria.
⁶ 6Institute of General Practice and Family Medicine, Witten/Herdecke University, Alfred-Herrhausen-Straße 50, 58448 Witten, Germany.
⁷ 7Division of Population Health, Health Services Research and Primary Care, School of Health Sciences, University of Manchester, Oxford Rd, Manchester, M13 9PL UK.

^# Contributed equally.

Abstract

Background: Type 2 diabetes is a chronic disease associated with poorer health outcomes and decreased health related quality of life (HRQoL). The aim of this analysis was to explore the impact of a disease management programme (DMP) in type 2 diabetes on HRQoL. A multilevel model was used to explain the variation in EQ-VAS.

Methods: A cluster-randomized controlled trial-analysis of the secondary endpoint HRQoL. Our study population were general practitioners and patients in the province of Salzburg. The DMP "Therapie-Aktiv" was implemented in the intervention group, and controls received usual care. Outcome measure was a change in EQ-VAS after 12 months. For comparison of rates, we used Fisher's Exact test; for continuous variables the independent T test or Welch test were used. In the multilevel modeling, we examined various models, continuously adding variables to explain the variation in the dependent variable, starting with an empty model, including only the random intercept. We analysed random effects parameters in order to disentangle variation of the final EQ-VAS.

Results: The EQ-VAS significantly increased within the intervention group (mean difference 2.19, p = 0.005). There was no significant difference in EQ-VAS between groups (mean difference 1.00, p = 0.339). In the intervention group the improvement was more distinct in women (2.46, p = 0.036) compared to men (1.92, p = 0.063). In multilevel modeling, sex, age, family and work circumstances, any macrovascular diabetic complication, duration of diabetes, baseline body mass index and baseline EQ-VAS significantly influence final EQ-VAS, while DMP does not. The final model explains 28.9% (EQ-VAS) of the total variance. Most of the unexplained variance was found on patient-level (95%) and less on GP-level (5%).

Conclusion: DMP "Therapie-Aktiv" has no significant impact on final EQ-VAS. The impact of DMPs in type 2 diabetes on HRQoL is still unclear and future programmes should focus on patient specific needs and predictors in order to improve HRQoL.Trial registration Current Controlled trials Ltd., ISRCTN27414162.

Keywords: Cluster randomised controlled trial; Disease management programme; Health related quality of life (EQ-5D-3L questionnaire); Multilevel modeling; Sex-specific analysis; Type 2 diabetes mellitus.