Dementia care initiative in primary practice – study protocol of a cluster randomized trial on dementia management in a general practice setting

<p>Abstract</p> <p>Background</p> <p>Current guidelines for dementia care recommend the combination of drug therapy with non-pharmaceutical measures like counselling and social support. However, the scientific evidence concerning non-pharmaceutical interventions for dementia patients and their informal caregivers remains inconclusive. Targets of modern comprehensive dementia care are to enable patients to live at home as long and as independent as possible and to reduce the burden of caregivers. The objective of the study is to compare a complex intervention including caregiver support groups and counselling against usual care in terms of time to nursing home placement. In this paper the study protocol is described.</p> <p>Methods/Design</p> <p>The IDA (Initiative Demenzversorgung in der Allgemeinmedizin) project is designed as a three armed cluster-randomized trial where dementia patients and their informal caregivers are recruited by general practitioners. Patients in the study region of Middle Franconia, Germany, are included if they have mild or moderate dementia, are at least 65 years old, and are members of the German AOK (Allgemeine Ortskrankenkasse) sickness fund. In the control group patients receive regular treatment, whereas in the two intervention groups general practitioners participate in a training course in evidence based dementia treatment, recommend support groups and offer counseling to the family caregivers either beginning at baseline or after the 1-year follow-up. The study recruitment and follow-up took place from July 2005 to January 2009. 303 general practitioners were randomized of which 129 recruited a total of 390 patients. Time to nursing home admission within the two year intervention and follow-up period is the primary endpoint. Secondary endpoints are cognitive status, activities of daily living, burden of care giving as well as healthcare costs. For an economic analysis from the societal perspective, data are collected from caregivers as well as by the use of routine data from statutory health insurance and long-term care insurance.</p> <p>Discussion</p> <p>From a public health perspective, the IDA trial is expected to lead to evidence based results on the community effectiveness of non-pharmaceutical support measures for dementia patients and their caregivers in the primary care sector. For health policy makers it is necessary to make their decisions about financing new services based on strong knowledge about the acceptance of measures in the population and their cost-effectiveness.</p> <p>Trial registration</p> <p>ISRCTN68329593</p

Dementia onset, incidence and risk in type 2 diabetes: a matched cohort study with the Fremantle Diabetes Study Phase I

Aims/hypothesis: The study aimed to assess the incidence, age of onset, survival and relative hazard of dementia in well-categorised community-based patients with type 2 diabetes compared with a matched cohort of individuals without diabetes. Methods: A longitudinal observational study was undertaken involving 1291 participants with type 2 diabetes from the Fremantle Diabetes Study and 5159 matched residents without documented diabetes. Linkage with health-related databases was used to detect incident dementia. Relative hazards were assessed using both cause-specific and subdistribution proportional hazards models. Results: During 13.8 ± 5.8 years of follow-up, incident dementia occurred in 13.9% and 12.4% of the groups of participants with and without diabetes, respectively (p = 0.15). With type 2 diabetes, the incidence of dementia was higher (incidence rate ratio [IRR] 1.28, 95% CI 1.08, 1.51), as was the competing risk of death (IRR 1.50, 95% CI 1.38, 1.64). The ages when dementia was first recorded and when death with dementia occurred were both earlier with diabetes, by 1.7 (95% CI 0.6, 2.9) and 2.3 (95% CI 1.1, 3.6) years, respectively (both p ≤ 0.004). Type 2 diabetes was associated with an adjusted subdistribution HR of 1.18 (95% CI 1.00, 1.39), and a cause-specific HR of 1.51 (95% CI 1.27, 1.78) for all-cause dementia. Conclusions/interpretation: Type 2 diabetes is associated with an increased incidence of dementia, and dementia onset occurs at a younger age. The relative hazards of both dementia and premature mortality are increased and, as a consequence, the increased risk of dementia in type 2 diabetes is not as marked as suggested by cause-specific HRs