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Randomized Controlled Trial
. 2012 Jul 17:345:e4693.
doi: 10.1136/bmj.e4693.

Efficacy of psychosocial intervention in patients with mild Alzheimer's disease: the multicentre, rater blinded, randomised Danish Alzheimer Intervention Study (DAISY)

F B Waldorff  1 , D V Buss, A Eckermann, M L H Rasmussen, N Keiding, S Rishøj, V Siersma, J Sørensen, L V Sørensen, A Vogel, G Waldemar
Affiliations
Randomized Controlled Trial

Efficacy of psychosocial intervention in patients with mild Alzheimer's disease: the multicentre, rater blinded, randomised Danish Alzheimer Intervention Study (DAISY)

F B Waldorff et al. BMJ. .

Abstract

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).

Conclusions: The 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.

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Conflict of interest statement

Competing interest: All authors have completed the ICMJE uniform disclosure form at www.icmje.org/coi_disclosure.pdf (available on request from the corresponding author) and declare: GW had support from the National Board of Social Services at the Danish Ministry of Social Affairs, the Danish Ministry of Health, and the Danish Health Foundation for the submitted work; no financial relationships with any organisations that might have an interest in the submitted work in the previous three years; no other relationships or activities that could appear to have influenced the submitted work.

Figures

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Flow of participants through Danish Alzheimer Intervention Study (DAISY)
See this image and copyright information in PMC

Comment in

References

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