Objective To assess the efficacy at 12 months of an early psychosocial counselling and support programme for outpatients with mild Alzheimer's disease and their primary care givers.Design Multicentre, randomised, controlled, rater blinded trial. Setting Primary care and memory clinics in five Danish districts.Participants 330 outpatients with mild Alzheimer's disease and their 330 primary care givers.Interventions Participating dyads (patient and primary care giver) were randomised to control support during follow-up or to control support plus DAISY intervention (multifaceted and semi-tailored counselling, education, and support).Main outcome measures Primary outcomes at 12 months for patients were change from baseline in mini mental state examination (MMSE) score, Cornell depression scale score, and proxy rated European quality of life visual analogue scale (EQ-VAS) score. For care givers, outcomes were change from baseline in geriatric depression scale (GDS 30 items) score and EQ-VAS score.Results Because of multiple testing, statistical significance was set at an adjusted P limit of <0.0005. At 12 months there were no significant differences between the two allocation groups in changes from baseline in the primary and secondary outcomes. However, although non-significant with the adjusted P limit, a small difference was observed for one of the primary patient outcomes (Cornell depression scale score) in patients in favour of the DAISY intervention group before and after adjusting for attrition (P=0.0146 and P=0.0103 respectively). ConclusionsThe multifaceted, semi-tailored intervention with counselling, education, and support for patients with mild Alzheimer's disease and their care givers did not have any significant effect beyond that with well structured follow-up support at 12 months after adjustment for multiple comparisons. The small positive effect found in the unadjusted primary outcome addressing depressive symptoms in patients may call for further research focusing on patients with Alzheimer's disease and comorbid depression. Trial registration ISRCTN74848736. IntroductionAlzheimer's disease is a common neurodegenerative disease characterised by progressive decline in cognitive, social, and occupational function, and often associated with affective symptoms and behavioural disturbances. 1 Alzheimer's disease accounts for 60-80% of all cases of dementia, and recent figures indicate that as many as 35 million people worldwide have dementia, which is projected to increase to 65 million within the next two decades. 2 Most patients with Alzheimer's disease reside in the community and require assistance and supervision from care givers. BeingCorrespondence to: F B Waldorff fransw@sund.ku.dk Extra material supplied by the author. Effect of the intervention compared with control (intention-to-treat analysis) on the primary and secondary outcomes and the difference of these outcomes from baseline, with outcomes reported as medians with interquartile ranges (see http://www.bmj.com/content/345/bmj.e469...

ObjectivesTo examine the long-term efficacy at the 36-month follow-up of an early psychosocial counselling and support programme lasting 8–12 months for community-dwelling patients with mild Alzheimer's disease and their caregivers.DesignMulticentre, randomised, controlled, rater-blinded trial.SettingPrimary care and memory clinics in five Danish districts.Participants330 home-dwelling patients with mild Alzheimer's disease and their primary caregivers (dyads).InterventionsDyads were randomised to receive intervention during the first year after diagnosis. Both intervention and control groups had follow-up visits at 3, 6, 12 and 36 months.Main outcome measuresPrimary outcomes for the patients assessed at 36-month follow-up were changes from baseline in global cognitive function (Mini-Mental State Examination), depressive symptoms (Cornell Depression Scale) and proxy-rated EuroQoL quality of life on visual analogue scale. The primary outcomes for the caregivers were changes from baseline in depressive symptoms (Geriatric Depression Scale) and self-rated EuroQoL quality of life on a visual analogue scale. The secondary outcome measures for the patient were proxy-rated Quality of Life Scale for Alzheimer's disease (QoL-AD), Neuropsychiatric Inventory-Questionnaire, Alzheimer's disease Cooperative Study Activities of Daily Living Scale, all-cause mortality and nursing home placement.ResultsAt a 36-month follow-up, 2 years after the completion of the Danish Alzheimer Intervention Study (DAISY), the unadjusted positive effects previously detected at the 12-month follow-up in one patient primary outcome (Cornell depression score) and one patient secondary outcome (proxy-rated QoL-AD) disappeared (Cornell depression score, p=0.93; proxy-rated QoL-AD, p=0.81). No long-term effect of DAISY intervention on any other primary and secondary outcomes was found at the 36-month follow-up.ConclusionsFor patients with very mild Alzheimer's disease and their caregivers, an intensive, multi-component, semitailored psychosocial intervention programme with counselling, education and support during the first year after diagnosis did not show any positive long-term effect on primary and secondary outcomes. Trial registrationThe study was registered in the Clinical Trial Database (http://www.controlled-trials.com/ISRCTN74848736).

Background: There is a lack of appropriately designed trials investigating the efficacy of psychosocial interventions for patients with mild dementia and their family caregivers. This paper reports the rationale and design of the Danish Alzheimer Disease Intervention Study and baseline characteristics of the cohort. Methods: The study was a 1-year multicentre randomized controlled rater-blinded trial with randomization to follow-up and a multifaceted semitailored intervention programme or to follow-up only (with extension of follow-up to 3 years). The intervention included a counselling programme, teaching courses, written information and logbooks. The outcomes included clinical efficacy parameters, patient satisfaction and health economic consequences. Results: A total of 330 patients and their 330 caregivers were included during a period of 18 months. The majority (65.2 %) of the caregivers were spouses. At inclusion the mean age of the patients and caregivers was 76.2 and 66.0 years, respectively. Conclusion: The study will explore the added value of a multifaceted intervention programme and contribute to the design of future interventions for patients with mild dementia and their caregivers.

ObjectiveTo assess the cost utility of early psychosocial intervention for patients with Alzheimer's disease and their primary caregivers.DesignCost utility evaluation alongside a multicentre, randomised controlled trial with 3 years of follow-up.SettingPrimary care and memory clinics in five Danish districts.Participants330 community-dwelling patients and their primary caregivers.InterventionPsychosocial counselling and support lasting 8–12 months after diagnosis and follow-up at 3, 6, 12 and 36 months in the intervention group or follow-up only in the control group.Main outcome measuresThe primary outcome measure was the cost of additional quality-adjusted life years (QALYs). Costs were measured from a societal perspective, including the costs of healthcare, social care, informal care and production loss. QALYs were estimated separately for the patient and the caregiver before aggregation for the main analysis.ResultsNone of the observed cost and QALY measures were significantly different between the intervention and control groups, although a tendency was noted for psychosocial care leading to cost increases with informal care that was not outweighed by the tendency for cost savings with formal care. The probability of psychosocial intervention being cost-effective did not exceed 36% for any threshold value. The alternative scenario analysis showed that the probability of cost-effectiveness increased over the range of threshold values used if the cost perspective was restricted to formal healthcare.ConclusionsA multifaceted, psychosocial intervention programme was found unlikely to be cost-effective from a societal perspective. The recommendation for practice in settings that are similar to the Danish setting is to provide follow-up with referral to available local support programmes when needed, and to restrict large multifaceted intervention programmes to patients and caregivers with special needs until further evidence for cost-effectiveness emerges.Trial registrationThe study was registered in the Clinical Trial Database as ISRCTN74848736.

Background/Aim: To investigate the impact of early psychosocial intervention aimed at patients with Alzheimer's disease (AD) and their caregivers on resource use and costs from a societal perspective. Methods: Dyads of patients and their primary caregiver were randomised to intervention (n = 163) or control (n = 167) and followed for 3 years. Health care use was extracted from national registers, and the Resource Utilisation in Dementia questionnaire was used to measure informal care and productivity loss. Multiple imputation was used to replace missing data, and non-parametric bootstrapping was used to estimate standard errors. Results: Overall, there were no statistically significant differences because of large variation in the observations. The average additional cost of psychosocial intervention provision was estimated at EUR 3,401 per patient. This cost masked a reduced use of formal health care and an increased use of informal care. Conclusions: Early psychosocial intervention in AD could be cost-saving from a health care perspective, whereas the opposite seems to be true from a broader societal perspective.

BackgroundAlzheimer's disease is the leading cause of dementia and affects about 25 million people worldwide. Recent studies have evaluated the effect of early interventions for dementia, but few studies have considered private time and transportation costs associated with the intervention. This study assessed the total economic costs associated with a multifaceted intervention for mild Alzheimer's disease, including an estimate of the ratio of public to private costs.MethodsThe study sample comprised 163 dyads of patients and caregivers who received a multifaceted intervention of counselling sessions, courses and informational packages. The typical duration of the intervention was 7 months. A micro-costing approach was applied using prospectively collected data on resource utilisation that included estimates of participant time and transportation. Precision estimates were calculated using a bootstrapping technique and structural uncertainty was assessed with sensitivity analysis.ResultsThe direct intervention cost was estimated at EUR 1,070 (95% CI 1,029;1,109). The total cost (including private costs) was estimated at EUR 2,020 (95% CI 1,929;2,106) i.e. the ratio of private to public costs was almost 1:1.ConclusionIntervention for mild Alzheimer's disease can be undertaken at a relatively low cost to public funds. However, policy planners should pay attention to the significant private costs associated with an intervention, which may ultimately pose a threat to equity in access to health care.Trial registrationCurrent Controlled Trials ISRCTN74848736.

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