Correction: Care management intervention to strengthen self-care of multimorbid patients with type 2 diabetes in a German primary care network: A randomized controlled trial.

[This corrects the article DOI: 10.1371/journal.pone.0214056.].

Care management intervention to strengthen self-care of multimorbid patients with type 2 diabetes in a German primary care network: A randomized controlled trial.

PURPOSE: This study aimed to assess the effectiveness of a care management intervention in improving self-management behavior in multimorbid patients with type 2 diabetes; care was delivered by medical assistants in the context of a primary care network (PCN) in Germany. METHODS: This study is an 18-month, multi-center, two-armed, open-label, patient-randomized parallel-group superiority trial (ISRCTN 83908315). The intervention group received the care management intervention in addition to the usual care. The control group received usual care only. The primary outcome was the change in self-care behavior at month 9 compared to baseline. The self-care behavior was measured with the German version of the Summary of Diabetes Self-Care Activities Measure (SDSCA-G). A multilevel regression analysis was applied. RESULTS: We assigned 495 patients to intervention (n = 252) and control (n = 243). At baseline, the mean age was 68 ±11 years, 47.8% of the patients were female and the mean HbA1c was 7.1±1.2%. The primary analysis showed no statistically significant effect, but a positive trend was observed (p = 0.206; 95%-CI = -0.084; 0.384). The descriptive analysis revealed a significantly increased sum score of the SDSCA-G in the intervention group over time (P = 0.012) but not in the control group (p = 0.1973). CONCLUSION: The sum score for self-care behavior markedly improved in the intervention group over time. However, the results of our primary analysis showed no statistically significant effect. Possible reasons are the high baseline performance in our sample and the low intervention fidelity. The implementation of this care management intervention in PCNs has the potential to improve self-care behavior of multimorbid patients with type 2 diabetes.

Meeting the needs of multimorbid patients with Type 2 diabetes mellitus - A randomized controlled trial to assess the impact of a care management intervention aiming to improve self-care.

AIMS: This study explored the impact of a care management intervention aiming to improve self-care behavior in multimorbid individuals with Type 2 diabetes mellitus on health-related quality of life (HRQoL). METHODS: A patient-level randomized parallel-group superiority trial with 32 primary care practice teams, 11 care managers and 495 patients was conducted. The intervention was delivered as add-on to an already implemented disease management program and embedded in a network of primary care practices. Hierarchical linear modeling was used to analyze impacts of the care management approach on HRQoL. RESULTS: Small improvements of HRQoL in the intervention arm were found after nine months (r = 0.024; 95%CI = [0.000, 0.047]). However, compared to standard care no significant differences of HRQoL changes were observed (r = 0.022; 95%CI = [-0.011, 0.054]). Subgroup analyses showed effects for female participants favoring the intervention arm (r = 0.059; 95%CI = [0.010, 0.108]). No significant differences between intervention and control arm for several other subgroups were observed, including subgroups defined by comorbidities. CONCLUSION: Additional care management did not influence HRQoL over and above standard disease management. Improving diabetes patients' self-care behavior in the context of structured disease management programs may be difficult to achieve. Women might benefit from additional care management, but this finding needs to be confirmed in future research.

Health-Related Quality of Life in Primary Care: Which Aspects Matter in Multimorbid Patients with Type 2 Diabetes Mellitus in a Community Setting?

BACKGROUND AND OBJECTIVE: Knowledge about predictors of health-related quality of life for multimorbid patients with type 2 diabetes mellitus in primary care could help to improve quality and patient-centeredness of care in this specific group of patients. Thus, the aim of this study was to investigate the impact of several patient characteristics on health-related quality of life of multimorbid patients with type 2 diabetes mellitus in a community setting. RESEARCH DESIGN AND METHODS: A cross-sectional study with 32 primary care practice teams in Mannheim, Germany, and randomly selected multimorbid patients with type 2 diabetes mellitus (N = 495) was conducted. In order to analyze associations of various patient characteristics with health-related quality of life (EQ-5D index) a multilevel analysis was applied. RESULTS: After excluding patients with missing data, the cohort consisted of 404 eligible patients. The final multilevel model highlighted six out of 14 explanatory patient variables which were significantly associated with health-related quality of life: female gender (r = -0.0494; p = .0261), school education of nine years or less (r = -0.0609; p = .0006), (physical) mobility restrictions (r = -0.1074; p = .0003), presence of chronic pain (r = -0.0916; p = .0004), diabetes-related distress (r = -0.0133; p < .0001), and BMI (r = -0.0047; p = .0045). CONCLUSION: The findings of this study suggest that increased diabetes-related distress, chronic pain, restrictions in (physical) mobility, female gender, as well as lower education and, increased BMI have a noteworthy impact on health-related quality of life in multimorbid patients with type 2 diabetes mellitus seen in primary care practices in a community setting. The highlighted aspects should gain much more attention when treating multimorbid patients with type 2 diabetes mellitus.

Assessing self-management in patients with diabetes mellitus type 2 in Germany: validation of a German version of the Summary of Diabetes Self-Care Activities measure (SDSCA-G).

BACKGROUND: One of the most widely used self-reporting tools assessing diabetes self-management in English is the Summary of Diabetes Self-Care Activities (SDSCA) measure. To date there is no psychometric validated instrument in German to assess self-management in patients with diabetes mellitus. Therefore, this study aimed to translate the SDSCA into German and examine its psychometric properties. METHODS: The English version of the SDSCA was translated into German following the guidelines for cultural adaptation. The German version of the SDSCA (SDSCA-G) was administered to a random sample of 315 patients with diabetes mellitus type 2. Reliability was analyzed using Cronbach's alpha coefficient and item characteristics were assessed. Exploratory and confirmatory factor analysis (EFA and CFA) were carried out to explore the construct validity. A multivariable linear regression model was used to identify the influence of predictor variables on the SDSCA-G sum score. RESULTS: The Cronbach's alpha for the SDSCA-G (all items) was α = 0.618 and an acceptable correlation between the SDSCA-G and Self-management Diabetes Mellitus-Questionnaire (SDQ) (ρ = 0.664) was identified. The EFA suggested a four factor construct as did the postulated model. The CFA showed the goodness of fit of the SDSCA-G. However, item 4 was found to be problematic regarding the analysis of psychometric properties. The omission of item 4 yielded an increase in Cronbach's alpha (α = 0.631) and improvements of the factor structure and model fit. No statistically significant influences of predictor variables on the SDSCA-G sum score were observed. CONCLUSION: The revised German version of the SDSCA (SDSCA-G) is a reliable and valid tool assessing self-management in adults with type 2 diabetes in Germany.

Practice network-based care management for patients with type 2 diabetes and multiple comorbidities (GEDIMAplus): study protocol for a randomized controlled trial.

BACKGROUND: Care management interventions in the German health-care system have been evaluated with promising results, but further research is necessary to explore their full potential in the context of multi-morbidity. Our aim in this trial is to assess the efficacy of a primary care practice network-based care management intervention in improving self-care behaviour among patients with type 2 diabetes mellitus and multiple co-occurring chronic conditions. METHODS/DESIGN: The study is designed as a prospective, 18-month, multicentre, investigator-blinded, two-arm, open-label, individual-level, randomized parallel-group superiority trial. We will enrol 582 patients with type 2 diabetes mellitus and at least two severe chronic conditions and one informal caregiver per patient. Data will be collected at baseline (T0), at the primary endpoint after 9 months (T1) and at follow-up after 18 months (T2). The primary outcome will be the differences between the intervention and control groups in changes of diabetes-related self-care behaviours from baseline to T1 using a German version of the revised Summary of Diabetes Self-Care Activities (SDSCA-G). The secondary outcomes will be the differences between the intervention and control groups in: changes in scores on the SDSCA-G subscales, glycosylated haemoglobin A level, health-related quality of life, self-efficacy, differences in (severe) symptomatic hypoglycaemia, cost-effectiveness and financial family burden. The intervention will be delivered by trained health-care assistants as an add-on to usual care and will consist of three main elements: (1) three home visits, including structured assessment of medical and social needs; (2) 24 structured telephone monitoring contacts; and (3) self-monitoring of blood glucose levels after T1 in 3-month intervals. The control group will receive usual care. The confirmatory primary analysis will be performed following the intention-to-treat (ITT) principle. The efficacy of the intervention will be quantified using two-level linear regression stratified by type of medical treatment adjusted for baseline values on the SDSCA-G. Secondary analyses will be performed according to the ITT principle. In health economic evaluations, we will estimate the incremental cost-effectiveness ratios. DISCUSSION: We hope that the results of this study will provide insights into the efficacy of practice network-based care management among patients with complex health-care needs. TRIAL REGISTRATION: Current Controlled Trials ISRCTN 83908315 (ISRCTN assigned 25 February 2014).