Cost-effectiveness analysis of cognitive behaviour therapy for treatment of minor or mild-major depression in elderly patients with type 2 diabetes: study protocol for the economic evaluation alongside the MIND-DIA randomized controlled trial (MIND-DIA CEA)

Chernyak, Nadja; Petrak, Frank; Plack, Kristin; Hautzinger, Martin; Müller, Matthias J.; Giani, Guido; Icks, Andrea

doi:10.1186/1471-2318-9-25

Cited by 9 publications

(5 citation statements)

References 49 publications

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“…The questionnaire used for the study was developed to conduct trial economic evaluations of interventions for patients with diabetes. 16 , 17 First, available health care utilization and comorbidity questionnaires were reviewed and then a new questionnaire more suitable for reflecting the specific aspects of diabetes was elaborated in close cooperation with clinical experts. We conducted interviews with patients from self-help groups and general practitioners in order to evaluate and further improve the questionnaire, using cognitive techniques such as paraphrasing to check whether the questions were consistently understood and could be answered by all the respondents.…”

Section: Methodsmentioning

confidence: 99%

How do patients with diabetes report their comorbidity? Comparison with administrative data

Hoffmann¹,

Haastert²,

Brüne³

et al. 2018

CLEP

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AimsPatients with diabetes are probably often unaware of their comorbidities. We estimated agreement between self-reported comorbidities and administrative data.MethodsIn a random sample of 464 diabetes patients, data from a questionnaire asking about the presence of 14 comorbidities closely related to diabetes were individually linked with statutory health insurance data.ResultsSpecificities were >97%, except cardiac insufficiency (94.5%), eye diseases (93.8%), peripheral arterial disease (92.6%), hypertension (90.9%), and peripheral neuropathy (85.8%). Sensitivities were <60%, except amputation (100%), hypertension (83.1%), and myocardial infarction (67.2%). A few positive predictive values were >90% (hypertension, myocardial infarction, and eye disease), and six were below 70%. Six negative predictive values were >90%, and two <70% (hypertension and eye disease). Total agreement was between 42.7% (eye disease) and 100% (dialysis and amputation). Overall, substantial agreement was observed for three morbidities (kappa 0.61–0.80: hypertension, myocardial infarction, and amputation). Moderate agreement (kappa 0.41–0.60) was estimated for angina pectoris, heart failure, stroke, peripheral neuropathy, and kidney disease. Factors associated with agreement were the number of comorbidities, diabetes duration, age, sex, and education.ConclusionsMyocardial infarction and amputation were well reported by patients as comorbidities; eye diseases and foot ulceration rather poorly, particularly in older, male, or less educated patients. Patient information needs improving.

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Section: Methodsmentioning

confidence: 99%

How do patients with diabetes report their comorbidity? Comparison with administrative data

Hoffmann¹,

Haastert²,

Brüne³

et al. 2018

CLEP

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“…The three outcomes estimated for the economic analysis will be depression-free years, quality adjusted life years (QALYs), and cumulative cost accrued in each arm of the trial. A detailed protocol of the cost-effectiveness analysis alongside the MIND-DIA study was published previously [ 42 ].…”

Section: Methodsmentioning

confidence: 99%

Cognitive behavioural therapy in elderly type 2 diabetes patients with minor depression or mild major depression: study protocol of a randomized controlled trial (MIND-DIA)

et al. 2010

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BackgroundThe global prevalence of diabetes among adults will be 6.4% in 2010 and will increase to 7.7% by 2030. Diabetes doubles the odds of depression, and 9% of patients with diabetes are affected by depressive disorders. When subclinical depression is included, the proportion of patients who have clinically relevant depressive symptoms increases to 26%. In patients aged over 65 years, the interaction of diabetes and depression has predicted increased mortality, complications, disability, and earlier occurrence of all of these adverse outcomes. These deleterious effects were observed even in minor depression, where the risk of mortality within 7 years was 4.9 times higher compared with diabetes patients who did not have depressive symptoms. In this paper we describe the design and methods of the Minor Depression and Diabetes trial, a clinical trial within the 'Competence Network for Diabetes mellitus', which is funded by the German Federal Ministry of Education and Research.Methods/DesignPatients' inclusion criteria are: Type 2 diabetes mellitus, 65 to 85 years of age, 3 to 6 depressive symptoms (minor depression or mild major depression). Our aim is to compare the efficacy of diabetes-specific cognitive behavioural therapy adapted for the elderly vs. intensified treatment as usual vs. a guided self-help intervention regarding improvement of health related quality of life as the primary outcome. The trial will be conducted as a multicentre, open, observer-blinded, parallel group (3 groups) randomized controlled trial. Patients will be randomized to one of the three treatment conditions. After 12 weeks of open-label therapy in all treatment conditions, both group interventions will be reduced to one session per month during the one-year long-term phase of the trial. At the one-year follow-up, all groups will be re-examined regarding the primary and secondary parameters, for example reduction of depressive symptoms, prevention of moderate/severe major depression, improvement of glycaemic control, mortality, and cost effectiveness. Depending on additional funding, the sample will be continuously observed as a prospective cohort; the primary outcome will be changed to mortality for all subsequent follow-up measurements.Trial registrationCurrent Controlled Trials Register (ISRCTN58007098).

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“…Only one other economic evaluation examined costs beyond the health care system, although this is also examined in three ongoing studies, one in the Netherlands (Horn et al, 2007) and two in Germany (Chernyak et al, 2010;Chernyak et al, 2009;Petrak et al, 2010). The completed study is for a clinical trial of a primary care nurse-led minimal psychological intervention (MPI) compared with usual care in the Netherlands (Jonkers et al, 2009).…”

Section: Economic Evaluations Of Interventions For Prevention or Trea...mentioning

confidence: 99%

Economic aspects of the association between diabetes and depression: A systematic review

Molosankwe

Patel

Gagliardino

et al. 2012

Journal of Affective Disorders

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Cost-effectiveness analysis of cognitive behaviour therapy for treatment of minor or mild-major depression in elderly patients with type 2 diabetes: study protocol for the economic evaluation alongside the MIND-DIA randomized controlled trial (MIND-DIA CEA)

Cited by 9 publications

References 49 publications

How do patients with diabetes report their comorbidity? Comparison with administrative data

How do patients with diabetes report their comorbidity? Comparison with administrative data

Cognitive behavioural therapy in elderly type 2 diabetes patients with minor depression or mild major depression: study protocol of a randomized controlled trial (MIND-DIA)

Economic aspects of the association between diabetes and depression: A systematic review

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