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Randomized Controlled Trial
. 2010 Jun 3:340:c2466.
doi: 10.1136/bmj.c2466.

Effectiveness of a specific care plan in patients with Alzheimer's disease: cluster randomised trial (PLASA study)

Fati Nourhashemi  1 , Sandrine Andrieu, Sophie Gillette-Guyonnet, Bruno Giraudeau, Christelle Cantet, Nicola Coley, Bruno Vellas; PLASA Group
Collaborators, Affiliations
Randomized Controlled Trial

Effectiveness of a specific care plan in patients with Alzheimer's disease: cluster randomised trial (PLASA study)

Fati Nourhashemi et al. BMJ. .

Abstract

Objective: To test the effectiveness of a comprehensive specific care plan in decreasing the rate of functional decline in patients with mild to moderate Alzheimer's disease compared with usual care in memory clinics.

Design: Cluster randomised trial.

Setting: 50 memory clinics in France.

Participants: Patients with Alzheimer's disease (mini-mental state examination score 12-26). 1131 patients were included: 574 from 26 clinics in the intervention group, and 557 from 24 clinics in the usual care (control) group. Memory clinics were the unit of randomisation.

Intervention: The intervention included a comprehensive standardised twice yearly consultation for patients and their caregivers, with standardised guidelines for the management of problems identified during the assessment.

Main outcome measures: The primary outcome measure was change on the Alzheimer's Disease Cooperative Study-activities of daily living scale assessed at 12 and 24 months. Secondary outcome measures were the rate of admission to institutional care and mortality.

Results: At two years the assessment was completed by 58.4% (n=335) of patients in the intervention group and 61.6% (n=343) in the control group. The rate of functional decline at two years did not differ between the groups. The annual rate of change on the Alzheimer's Disease Cooperative Study-activities of daily living was estimated at -5.73 (95% confidence interval -6.89 to -4.57) in the intervention group and -5.96 (-7.05 to -4.86) in the control group (P=0.78).

Conclusion: A comprehensive specific care plan in memory clinics had no additional positive effect on functional decline in patients with mild to moderate Alzheimer's disease. Future research should aim to determine the effects of more direct involvement of general practitioners.

Trial registration: ClinicalTrials.gov NCT00480220.

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Conflict of interest statement

Competing interests: All authors have completed the unified competing interest form at www.icmje.org/coi_disclosure.pdf (available on request from the corresponding author) and declare (1) no financial support for the submitted work from anyone other than their employer; (2) no financial relationships with commercial entities that might have an interest in the submitted work; (3) no spouses, partners, or children with relationships with commercial entities that might have an interest in the submitted work; and (4) no non-financial interests that may be relevant to the submitted work.

Figures

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Flow of participants through study
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Comment in

References

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