Top

04-10-2018 | Diabetes self-management | Article

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

Journal: Diabetology & Metabolic Syndrome

Authors: Sigrid Panisch, Tim Johansson, Maria Flamm, Henrike Winkler, Raimund Weitgasser, Andreas C. Sönnichsen

Publisher: BioMed Central

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

Engelgau MM, Geiss LS, Saaddine JB, Boyle JP, Benjamin SM, Gregg EW, et al. The evolving diabetes burden in the United States. Ann Intern Med. 2004;140(11):945–50.CrossRefPubMed

King H, Aubert RE, Herman WH. Global burden of diabetes, 1995-2025: prevalence, numerical estimates, and projections. Diabetes Care. 1998;21(9):1414–31.CrossRefPubMed

Ofman JJ, Badamgarav E, Henning JM, Knight K, Gano AD Jr, Levan RK, et al. Does disease management improve clinical and economic outcomes in patients with chronic diseases? A systematic review. Am J Med. 2004;117(3):182–92.CrossRefPubMed

Pimouguet C, Le GM, Thiebaut R, Dartigues JF, Helmer C. Effectiveness of disease-management programs for improving diabetes care: a meta-analysis. CMAJ. 2011;183(2):E115–27.CrossRefPubMedPubMedCentral

Rubin RR, Peyrot M. Quality of life and diabetes. Diabetes Metab Res Rev. 1999;15(3):205–18.CrossRefPubMed

Solli O, Stavem K, Kristiansen IS. Health-related quality of life in diabetes: the associations of complications with EQ-5D scores. Health Qual Life Outcomes. 2010;8:18.CrossRefPubMedPubMedCentral

Wexler DJ, Grant RW, Wittenberg E, Bosch JL, Cagliero E, Delahanty L, et al. Correlates of health-related quality of life in type 2 diabetes. Diabetologia. 2006;49(7):1489–97.CrossRefPubMed

Fortin M, Bravo G, Hudon C, Lapointe L, Almirall J, Dubois MF, et al. Relationship between multimorbidity and health-related quality of life of patients in primary care. Qual Life Res. 2006;15(1):83–91.CrossRefPubMed

Grandy S, Fox KM. EQ-5D visual analog scale and utility index values in individuals with diabetes and at risk for diabetes: findings from the study to help improve early evaluation and management of risk factors leading to diabetes (SHIELD). Health Qual Life Outcomes. 2008;6:18.CrossRefPubMedPubMedCentral

10.

Hodek JM, Ruhe A, Greiner W. Multimorbidity and health-related quality of life among elderly persons. Bundesgesundheitsblatt Gesundheitsforschung Gesundheitsschutz. 2009;52(12):1188–201.CrossRefPubMed

11.

Holmes J, McGill S, Kind P, Bottomley J, Gillam S, Murphy M. Health-related quality of life in type 2 diabetes (TARDIS-2). Value Health. 2000;3(Suppl 1):47–51.CrossRefPubMed

12.

Koopmanschap M. Coping with type II diabetes: the patient’s perspective. Diabetologia. 2002;45(7):S18–22.PubMed

13.

Peters SA, Huxley RR, Woodward M. Diabetes as a risk factor for stroke in women compared with men: a systematic review and meta-analysis of 64 cohorts, including 775,385 individuals and 12,539 strokes. Lancet. 2014;383(9933):1973–80.CrossRefPubMed

14.

Peters SA, Huxley RR, Woodward M. Diabetes as risk factor for incident coronary heart disease in women compared with men: a systematic review and meta-analysis of 64 cohorts including 858,507 individuals and 28,203 coronary events. Diabetologia. 2014;57(8):1542–51.CrossRefPubMed

15.

Sonnichsen AC, Winkler H, Flamm M, Panisch S, Kowatsch P, Klima G, et al. The effectiveness of the Austrian disease management programme for type 2 diabetes: a cluster-randomised controlled trial. BMC Fam Pract. 2010;11:86.CrossRefPubMedPubMedCentral

16.

Ose D, Miksch A, Urban E, Natanzon I, Szecsenyi J, Kunz CU, et al. Health related quality of life and comorbidity. A descriptive analysis comparing EQ-5D dimensions of patients in the German disease management program for type 2 diabetes and patients in routine care. BMC Health Serv Res. 2011;11:179.CrossRefPubMedPubMedCentral

17.

Miksch A, Hermann K, Trieschmann J, Roelz A, Heiderhoff M, Laux G, et al. Gender-specific differences in quality of life of patients with type 2 diabetes with or without participating in DMP. Gesundheitswesen. 2008;70(4):250–5.CrossRefPubMed

18.

Ose D, Wensing M, Szecsenyi J, Joos S, Hermann K, Miksch A. Impact of primary care-based disease management on the health-related quality of life in patients with type 2 diabetes and comorbidity. Diabetes Care. 2009;32(9):1594–6.CrossRefPubMedPubMedCentral

19.

Laxy M, Stark R, Meisinger C, Kirchberger I, Heier M, von Scheidt W, et al. The effectiveness of German disease management programs (DMPs) in patients with type 2 diabetes mellitus and coronary heart disease: results from an observational longitudinal study. Diabetol Metab Syndr. 2015;7:77.CrossRefPubMedPubMedCentral

20.

Mehring M, Donnachie E, Bonke FC, Werner C, Schneider A. Disease management programs for patients with type 2 diabetes mellitus in Germany: a longitudinal population-based descriptive study. Diabetol Metab Syndr. 2017;9:37.CrossRefPubMedPubMedCentral

21.

Sonnichsen AC, Rinnerberger A, Url MG, Winkler H, Kowatsch P, Klima G, et al. Effectiveness of the Austrian disease-management-programme for type 2 diabetes: study protocol of a cluster-randomized controlled trial. Trials. 2008;9:38.CrossRefPubMedPubMedCentral

22.

The disease management programme for type 2 diabetes in Austria. http://www.therapie-aktiv.at. Accessed 23 Sep 2014.

23.

Weitgasser R. Diabetesschulung, “Neu” für Patienten mit Typ-2-Diabetes im Land Salzburg. Diabetes Stoffwechsel und Herz. 2009;18:25–7.

24.

Austrian Diabetes Association. Diabetes mellitus–guidelines for the practice. Revised and expanded 2007 edition. Wien Klin Wochenschr. 2009;121(Suppl 5):S1–87.

25.

EuroQol Group. EuroQol–a new facility for the measurement of health-related quality of life. The EuroQol Group. Health Policy. 1990;16(3):199–208.CrossRef

26.

Rabin R, Oemar M, Oppe M. EQ-5D-3L User Guide. Basic information on how to use the EQ-5D-3L instrument. [Version 4.0]. Rotterdam: EuroQol Group; 2011.

27.

Brundage M, Bass B, Davidson J, Queenan J, Bezjak A, Ringash J, et al. Patterns of reporting health-related quality of life outcomes in randomized clinical trials: implications for clinicians and quality of life researchers. Qual Life Res. 2011;20(5):653–64.CrossRefPubMed

28.

MLwinN Version 2.1. [computer program]. Version 2.1. 2009.

29.

Flamm M, Panisch S, Winkler H, Sonnichsen AC. Impact of a randomized control group on perceived effectiveness of a Disease Management Programme for diabetes type 2. Eur J Public Health. 2012;22(5):625–9.CrossRefPubMed

30.

Rakovac I, Plank J, Jeitler K, Beck P, Seereiner S, Mrak P, et al. Health status of type 2 diabetics in Austria—perspective of a quality improvement initiative. Wien Med Wochenschr. 2009;159(5–6):126–33.CrossRefPubMed

31.

Speight J, Reaney MD, Barnard KD. Not all roads lead to Rome-a review of quality of life measurement in adults with diabetes. Diabet Med. 2009;26(4):315–27.CrossRefPubMed

32.

Glasziou P, Alexander J, Beller E, Clarke P. Which health-related quality of life score? A comparison of alternative utility measures in patients with Type 2 diabetes in the ADVANCE trial. Health Qual Life Outcomes. 2007;5:21.CrossRefPubMedPubMedCentral

33.

Matza LS, Boye KS, Yurgin N. Validation of two generic patient-reported outcome measures in patients with type 2 diabetes. Health Qual Life Outcomes. 2007;5:47.CrossRefPubMedPubMedCentral

34.

Rabin R, de Charro F. EQ-5D: a measure of health status from the EuroQol Group. Ann Med. 2001;33(5):337–43.CrossRefPubMed

35.

Pickard AS, Neary MP, Cella D. Estimation of minimally important differences in EQ-5D utility and VAS scores in cancer. Health Qual Life Outcomes. 2007;5:70.CrossRefPubMedPubMedCentral

36.

Chaveepojnkamjorn W, Pichainarong N, Schelp FP, Mahaweerawat U. A randomized controlled trial to improve the quality of life of type 2 diabetic patients using a self-help group program. Southeast Asian J Trop Med Public Health. 2009;40(1):169–76.PubMed

37.

Olivarius NF, Beck-Nielsen H, Andreasen AH, Horder M, Pedersen PA. Randomised controlled trial of structured personal care of type 2 diabetes mellitus. BMJ. 2001;323(7319):970–5.CrossRefPubMedPubMedCentral

38.

Davies MJ, Heller S, Skinner TC, Campbell MJ, Carey ME, Cradock S, et al. Effectiveness of the diabetes education and self management for ongoing and newly diagnosed (DESMOND) programme for people with newly diagnosed type 2 diabetes: cluster randomised controlled trial. BMJ. 2008;336(7642):491–5.CrossRefPubMedPubMedCentral

39.

Hill-Briggs F, Gary TL, Baptiste-Roberts K, Brancati FL. Thirty-six-item short-form outcomes following a randomized controlled trial in type 2 diabetes. Diabetes Care. 2005;28(2):443–4.CrossRefPubMed

40.

Sturt JA, Whitlock S, Fox C, Hearnshaw H, Farmer AJ, Wakelin M, et al. Effects of the diabetes manual 1:1 structured education in primary care. Diabet Med. 2008;25(6):722–31.CrossRefPubMed

41.

Sullivan MD, Anderson RT, Aron D, Atkinson HH, Bastien A, Chen GJ, et al. Health-related quality of life and cost-effectiveness components of the action to control cardiovascular risk in diabetes (ACCORD) trial: rationale and design. Am J Cardiol. 2007;99(12A):90i–102i.CrossRefPubMed

42.

Tankova T, Dakovska G, Koev D. Education and quality of life in diabetic patients. Patient Educ Couns. 2004;53(3):285–90.CrossRefPubMed

43.

Trento M, Passera P, Borgo E, Tomalino M, Bajardi M, Cavallo F, et al. A 5-year randomized controlled study of learning, problem solving ability, and quality of life modifications in people with type 2 diabetes managed by group care. Diabetes Care. 2004;27(3):670–5.CrossRefPubMed

44.

Tuthill A, Quinn A, McColgan D, McKenna M, O’Shea D, McKenna TJ. A prospective randomized controlled trial of lifestyle intervention on quality of life and cardiovascular risk score in patients with obesity and type 2 diabetes. Diabetes Obes Metab. 2007;9(6):917–9.CrossRefPubMed

45.

Varroud-Vial M, Simon D, Attali J, Durand-Zaleski I, Bera L, Attali C, et al. Improving glycaemic control of patients with Type 2 diabetes in a primary care setting: a French application of the Staged Diabetes Management programme. Diabet Med. 2004;21(6):592–8.CrossRefPubMed

46.

de Belvis AG, Pelone F, Biasco A, Ricciardi W, Volpe M. Can primary care professionals’ adherence to Evidence Based Medicine tools improve quality of care in type 2 diabetes mellitus? A systematic review. Diabetes Res Clin Pract. 2009;85(2):119–31.CrossRefPubMed

47.

Schafer I, Kuver C, Gedrose B, von Leitner EC, Treszl A, Wegscheider K, et al. Selection effects may account for better outcomes of the German Disease Management Program for type 2 diabetes. BMC Health Serv Res. 2010;31(10):351.CrossRef

48.

Kousoulis AA, Patelarou E, Shea S, Foss C, Ruud Knutsen IA, Todorova E, et al. Diabetes self-management arrangements in Europe: a realist review to facilitate a project implemented in six countries. BMC Health Serv Res. 2014;2(14):453.CrossRef

49.

Johansson T, Keller S, Winkler H, Ostermann T, Weitgasser R, Sonnichsen AC. Effectiveness of a peer support programme versus usual care in disease management of diabetes mellitus type 2 regarding improvement of metabolic control: a cluster-randomised controlled trial. J Diabetes Res. 2016;2016:3248547.CrossRefPubMed

50.

Paul G, Smith SM, Whitford D, O’Kelly F, O’Dowd T. Development of a complex intervention to test the effectiveness of peer support in type 2 diabetes. BMC Health Serv Res. 2007;31(7):136.CrossRef

Be confident that your patient care is up to date

Medicine Matters is being incorporated into Springer Medicine, our new medical education platform.

Alongside the news coverage and expert commentary you have come to expect from Medicine Matters diabetes, Springer Medicine's complimentary membership also provides access to articles from renowned journals and a broad range of Continuing Medical Education programs. Create your free account »