Dataset Information

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

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.

SUBMITTER: Waldorff FB

PROVIDER: S-EPMC3398860 | biostudies-literature |

REPOSITORIES: biostudies-literature

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Project description: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.

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