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Peyrot M.,Loyola University Maryland | Burns K.K.,University of Alberta | Davies M.,University of Leicester | Forbes A.,King's College London | And 8 more authors.
Diabetes Research and Clinical Practice | Year: 2013

Aims: The Diabetes Attitudes Wishes and Needs 2 (DAWN2) study aims to provide a holistic assessment of diabetes care and management among people with diabetes (PWD), family members (FM), and healthcare professionals (HCPs) and explores potential drivers leading to active management. Methods: DAWN2 survey over 16,000 individuals (∼9000 PWD, ∼2000 FM of PWD, and ∼5000 HCPs) in 17 countries across 4 continents. Respondents complete a group-specific questionnaire; items are designed to allow cross-group comparisons on common topics. The questionnaires comprise elements from the original DAWN study (2001), as well as psychometrically validated instruments and novel questions developed for this study to assess self-management, attitudes/beliefs, disease impact/burden, psychosocial distress, health-related quality of life, healthcare provision/receipt, social support and priorities for improvement in the future. The questionnaires are completed predominantly online or by telephone interview, supplemented by face-to-face interviews in countries with low internet access. In each country, recruitment ensures representation of the diabetes population in terms of geographical distribution, age, gender, education and disease status. Discussion: DAWN2 aims to build on the original DAWN study to identify new avenues for improving diabetes care. This paper describes the study rationale, goals and methodology. © 2012 Elsevier Ireland Ltd.


Hermanns N.,Research Institute of the Diabetes Academy Mergentheim FIDAM | Kulzer B.,Research Institute of the Diabetes Academy Mergentheim FIDAM | Maier B.,Research Institute of the Diabetes Academy Mergentheim FIDAM | Mahr M.,Research Institute of the Diabetes Academy Mergentheim FIDAM | Haak T.,Research Institute of the Diabetes Academy Mergentheim FIDAM
Patient Education and Counseling | Year: 2012

Objective: In a randomized, multi-centre trial, the effect of an education programme (MEDIAS 2 ICT) involving intensive insulin treatment for people with type 2 diabetes was compared with an established education programme as an active comparator condition (ACC). Methods: We investigated whether MEDIAS 2 ICT was non-inferior to ACC in overall glycaemic control. Secondary outcomes were the diabetes-related distress, diabetes knowledge, quality of life, self-care behavior, lipids, blood pressure and weight. Results: 186 subjects were randomized. After a six month follow-up the mean HbA1c decrease was 0.37% (from 8.2 ± 1.1% to 7.8 ± 1.5%) in the ACC and 0.63% (from 8.5 ± 1.5% to 7.9 ± 1.2%) in MEDIAS 2 ICT. The mean difference between both groups was -0.26% (95% CI -0.63 to -0.14) in favor of MEDIAS 2 ICT. This result was within the predefined limit for non-inferiority. Diabetes-related distress was significantly more reduced in MEDIAS 2 ICT (-3.4 ± 7.1) than in ACC (0.4 ± 9.0; p = 0.31). Conclusion: MEDIAS 2 ICT is as effective in lowering HbA1c as previously established education programmes, but showed superiority in reducing diabetes-related distress. Practical implications: MEDIAS 2 ICT provides an alternative for education of people with type 2 diabetes treated by multiple injection therapy. © 2011 Elsevier Ireland Ltd.


Schmitt A.,Research Institute of the Diabetes Academy Mergentheim FIDAM | Reimer A.,Research Institute of the Diabetes Academy Mergentheim FIDAM | Kulzer B.,Research Institute of the Diabetes Academy Mergentheim FIDAM | Haak T.,Research Institute of the Diabetes Academy Mergentheim FIDAM | And 2 more authors.
Journal of Behavioral Medicine | Year: 2015

Evidence of the negative impact of depression on glycaemic control is equivocal, and diabetes-related distress has been proposed as potential mediator. 466 diabetes patients were cross-sectionally assessed for depression (Center for Epidemiologic Studies Depression Scale), diabetes-related distress (Diabetes Distress Scale), and glycaemic control (HbA1c). We distinguished the associations of depression and diabetes distress with glycaemic control using analysis of variance and multiple regression. Neither patients with depression only nor diabetes distress only differed significantly from controls regarding HbA1c. However, HbA1c was substantially increased when both conditions were present (9.2 vs. 8.6 %, P = 0.01). As in previous studies, we observed a significant association between depression and hyperglycaemia (P < 0.01). However, a mediation analysis revealed that this association in fact depended on the presence of diabetes distress (P < 0.01). Depression seems to be associated with hyperglycaemia particularly when accompanied by diabetes distress, suggesting that adjusting clinical procedures regarding diabetes distress may facilitate the identification and care of high-risk patients. © 2014, Springer Science+Business Media New York.


Schmitt A.,Research Institute of the Diabetes Academy Mergentheim FIDAM | Gahr A.,Research Institute of the Diabetes Academy Mergentheim FIDAM | Hermanns N.,Research Institute of the Diabetes Academy Mergentheim FIDAM | Kulzer B.,Research Institute of the Diabetes Academy Mergentheim FIDAM | And 2 more authors.
Health and Quality of Life Outcomes | Year: 2013

Background: Though several questionnaires on self-care and regimen adherence have been introduced, the evaluations do not always report consistent and substantial correlations with measures of glycaemic control. Small ability to explain variance in HbA1c constitutes a significant limitation of an instrument's use for scientific purposes as well as clinical practice. In order to assess self-care activities which can predict glycaemic control, the Diabetes Self-Management Questionnaire (DSMQ) was designed.Methods: A 16 item questionnaire to assess self-care activities associated with glycaemic control was developed, based on theoretical considerations and a process of empirical improvements. Four subscales, 'Glucose Management' (GM), 'Dietary Control' (DC), 'Physical Activity' (PA), and 'Health-Care Use' (HU), as well as a 'Sum Scale' (SS) as a global measure of self-care were derived. To evaluate its psychometric quality, 261 patients with type 1 or 2 diabetes were assessed with the DSMQ and an established analogous scale, the Summary of Diabetes Self-Care Activities Measure (SDSCA). The DSMQ's item and scale characteristics as well as factorial and convergent validity were analysed, and its convergence with HbA1c was compared to the SDSCA.Results: The items showed appropriate characteristics (mean item-total-correlation: 0.46 ± 0.12; mean correlation with HbA1c: -0.23 ± 0.09). Overall internal consistency (Cronbach's alpha) was good (0.84), consistencies of the subscales were acceptable (GM: 0.77; DC: 0.77; PA: 0.76; HU: 0.60). Principal component analysis indicated a four factor structure and confirmed the designed scale structure. Confirmatory factor analysis indicated appropriate fit of the four factor model. The DSMQ scales showed significant convergent correlations with their parallel SDSCA scales (GM: 0.57; DC: 0.52; PA: 0.58; HU: n/a; SS: 0.57) and HbA1c (GM: -0.39; DC: -0.30; PA: -0.15; HU: -0.22; SS: -0.40). All correlations with HbA1c were significantly stronger than those obtained with the SDSCA.Conclusions: This study provides preliminary evidence that the DSMQ is a reliable and valid instrument and enables an efficient assessment of self-care behaviours associated with glycaemic control. The questionnaire should be valuable for scientific analyses as well as clinical use in both type 1 and type 2 diabetes patients. © 2013 Schmitt et al.; licensee BioMed Central Ltd.


Ehrmann D.,Research Institute of the Diabetes Academy Mergentheim FIDAM | Kulzer B.,Research Institute of the Diabetes Academy Mergentheim FIDAM | Kulzer B.,Diabetes Center Mergentheim | Haak T.,Research Institute of the Diabetes Academy Mergentheim FIDAM | And 3 more authors.
Diabetic Medicine | Year: 2015

Aim: To investigate the longitudinal bi-directionality of diabetes-related distress and depressive symptoms. Methods: A total of 509 patients receiving intensified insulin therapy completed the Centre for Epidemiological Studies Depression scale questionnaire for the assessment of depressive symptoms as well as the Problem Areas in Diabetes questionnaire for the assessment of diabetes-related distress at baseline and at 6-month follow-up. Separate logistic and linear regression analyses for incidence and persistence were performed with demographic (age, gender, BMI) and medical (diabetes type, HbA1c, diabetes duration, late complications) control variables. Results: Diabetes-related distress at baseline increased the risk of the incidence of elevated depressive symptoms by 2.56-fold (odds ratio 2.56; 95% CI 1.15-5.72; P=0.02) when controlling for demographic and medical variables. In addition, diabetes-related distress at baseline doubled the chance of the persistence of elevated depressive symptoms (odds ratio 2.04, 95% CI 1.04-3.99; P=0.04) when controlling for demographic and medical variables. The chance of having persistent elevated diabetes-related distress was increased 5.94-fold (odds ratio 5.94, 95% CI 2.60-13.59; P<0.0001) when elevated depressive symptoms were present at baseline. None of the medical variables had an influence on incidence or persistence. Conclusions: Diabetes-related distress was identified as a risk factor for the incidence and persistence of depressive symptoms. Reducing diabetes-related distress could help to prevent the development of elevated depressive symptoms. Furthermore, depressive symptoms were identified as an amplifier for diabetes-related distress. Diabetes-related distress and depressive symptoms were independent risk factors for each other and should be monitored in routine care to disentangle their influence. © 2015 Diabetes UK.


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.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.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; -0.01, 95% CI -0.33 to 0.31) and hypoglycaemia unawareness (-0.5 1.4 vs. -0.3 1.4; 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.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.


PubMed | Research Institute of the Diabetes Academy Mergentheim FIDAM
Type: Journal Article | Journal: Patient education and counseling | Year: 2012

In a randomized, multi-centre trial, the effect of an education programme (MEDIAS 2 ICT) involving intensive insulin treatment for people with type 2 diabetes was compared with an established education programme as an active comparator condition (ACC).We investigated whether MEDIAS 2 ICT was non-inferior to ACC in overall glycaemic control. Secondary outcomes were the diabetes-related distress, diabetes knowledge, quality of life, self-care behavior, lipids, blood pressure and weight.186 subjects were randomized. After a six month follow-up the mean HbA1c decrease was 0.37% (from 8.21.1% to 7.81.5%) in the ACC and 0.63% (from 8.51.5% to 7.91.2%) in MEDIAS 2 ICT. The mean difference between both groups was -0.26% (95% CI -0.63 to -0.14) in favor of MEDIAS 2 ICT. This result was within the predefined limit for non-inferiority. Diabetes-related distress was significantly more reduced in MEDIAS 2 ICT (-3.47.1) than in ACC (0.49.0; p=0.31).MEDIAS 2 ICT is as effective in lowering HbA1c as previously established education programmes, but showed superiority in reducing diabetes-related distress.MEDIAS 2 ICT provides an alternative for education of people with type 2 diabetes treated by multiple injection therapy.


PubMed | Research Institute of the Diabetes Academy Mergentheim FIDAM
Type: | Journal: Health and quality of life outcomes | Year: 2013

Though several questionnaires on self-care and regimen adherence have been introduced, the evaluations do not always report consistent and substantial correlations with measures of glycaemic control. Small ability to explain variance in HbA1c constitutes a significant limitation of an instruments use for scientific purposes as well as clinical practice. In order to assess self-care activities which can predict glycaemic control, the Diabetes Self-Management Questionnaire (DSMQ) was designed.A 16 item questionnaire to assess self-care activities associated with glycaemic control was developed, based on theoretical considerations and a process of empirical improvements. Four subscales, Glucose Management (GM), Dietary Control (DC), Physical Activity (PA), and Health-Care Use (HU), as well as a Sum Scale (SS) as a global measure of self-care were derived. To evaluate its psychometric quality, 261 patients with type 1 or 2 diabetes were assessed with the DSMQ and an established analogous scale, the Summary of Diabetes Self-Care Activities Measure (SDSCA). The DSMQs item and scale characteristics as well as factorial and convergent validity were analysed, and its convergence with HbA1c was compared to the SDSCA.The items showed appropriate characteristics (mean item-total-correlation: 0.46 0.12; mean correlation with HbA1c: -0.23 0.09). Overall internal consistency (Cronbachs alpha) was good (0.84), consistencies of the subscales were acceptable (GM: 0.77; DC: 0.77; PA: 0.76; HU: 0.60). Principal component analysis indicated a four factor structure and confirmed the designed scale structure. Confirmatory factor analysis indicated appropriate fit of the four factor model. The DSMQ scales showed significant convergent correlations with their parallel SDSCA scales (GM: 0.57; DC: 0.52; PA: 0.58; HU: n/a; SS: 0.57) and HbA1c (GM: -0.39; DC: -0.30; PA: -0.15; HU: -0.22; SS: -0.40). All correlations with HbA1c were significantly stronger than those obtained with the SDSCA.This study provides preliminary evidence that the DSMQ is a reliable and valid instrument and enables an efficient assessment of self-care behaviours associated with glycaemic control. The questionnaire should be valuable for scientific analyses as well as clinical use in both type 1 and type 2 diabetes patients.


PubMed | Research Institute of the Diabetes Academy Mergentheim FIDAM
Type: Journal Article | Journal: Diabetic medicine : a journal of the British Diabetic Association | Year: 2016

To compare the properties of the two most commonly used assessment tools for diabetes distress, the Problem Areas in Diabetes Scale (PAID) and the Diabetes Distress Scale (DDS), in order to discriminate their psychometric capabilities and functions.Six hundred and twenty-eight people with diabetes (67% Type1, 33% Type2) were cross-sectionally assessed with the PAID, the DDS and further self-report scales regarding coping, quality of life, depressive symptoms and self-care, and medical data were gained. We analysed the PAID and DDS for areas of contentual/psychometric divergence in assessing diabetes distress and compared their associations with criteria of interest.Content analysis: The PAID covers a greater variety of emotional concerns and shows a stronger focus on food-related problems and complications. The DDS is more reflective of physician-related distress and problems concerning diabetes self-management. Psychometric analysis: Exploratory factor analyses revealed four-factor structures of both scales, explaining 60% (PAID) and 67% (DDS) of variance. Confirmatory factor analyses confirmed that single-factor and four-factor models fit the data. Total scales proved high and subscales mostly satisfactory reliability. Associations with criteria of interest: The PAID was significantly more strongly associated with dysfunctional coping styles, quality of life and depressive symptoms. The DDS showed significantly stronger associations with diabetes self-care and metabolic outcomes.Our results support both PAID and DDS as good self-report measures of diabetes distress. The observed contentual/psychometric differences suggest that a justified choice with regard to the intended clinical or scientific purpose can improve the acquisition of the required data.


PubMed | Research Institute of the Diabetes Academy Mergentheim FIDAM
Type: Journal Article | Journal: Journal of behavioral medicine | Year: 2015

Evidence of the negative impact of depression on glycaemic control is equivocal, and diabetes-related distress has been proposed as potential mediator. 466 diabetes patients were cross-sectionally assessed for depression (Center for Epidemiologic Studies Depression Scale), diabetes-related distress (Diabetes Distress Scale), and glycaemic control (HbA1c). We distinguished the associations of depression and diabetes distress with glycaemic control using analysis of variance and multiple regression. Neither patients with depression only nor diabetes distress only differed significantly from controls regarding HbA1c. However, HbA1c was substantially increased when both conditions were present (9.2 vs. 8.6 %, P = 0.01). As in previous studies, we observed a significant association between depression and hyperglycaemia (P < 0.01). However, a mediation analysis revealed that this association in fact depended on the presence of diabetes distress (P < 0.01). Depression seems to be associated with hyperglycaemia particularly when accompanied by diabetes distress, suggesting that adjusting clinical procedures regarding diabetes distress may facilitate the identification and care of high-risk patients.

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