A randomized trial of the impact of a specific care plan in 1120 Alzheimer's patients (PLASA Study) over a two-year period: design and baseline data

Abstract

Objective: To describe the design anf baseline patient characteristics of a multicomponent specific care and assistance plan (PLASA) study in Alzheimer's Disease (AD). The study is designed to evaluate the effect of PLASA in AD primarily looking at change in functional capacity.

Design: Two-years prospective cluster randomized controlled trial comparing PLASA and usual care.

Setting: Forty-nine hospitals in France.

Participants: 1120 community-dwelling AD.

Intervention: Patients in the intervention group are evaluated biannually using a standardized comprehensive global assessment. In the case of decline in any one domain a standardized study protocol recommends specific physician directed intervention in addition to information and training for the caregiver.

Measurements: Alzheimer Disease Cooperative Study-Activities of Daily Living scale, Resource Utilization in Dementia scale, Clinical Global Impression of Change.

Results: At baseline, the two groups were similar regarding patient and caregiver characteristics. The mean patient age was 79.61+5.72 years and the mean MMSE 19.73+4.01 for the whole cohort. Time since dementia diagnosis was about 1.37+1.65 years in the whole cohort. Almost a third of the patients lived alone at baseline. Mean monthly time spent in caregiving in the whole cohort was 52.70+71.83 hours for instrumental activities and 17.73+51.38 hours for basic activities.

Conclusion: Persons with dementia suffer different losses at different stages of the disease and therefore accurate assessment of abilities and losses is critical to assist the person in planning for their future and for care needs. The PLASA intervention study is ongoing with 2 year follow-up to be completed in 2007.

Trial registration: ClinicalTrials.gov NCT00480220.