Effectiveness of a specific care plan in patients with Alzheimer’s disease: cluster randomised trial (PLASA study)BMJ 2010; 340 doi: https://doi.org/10.1136/bmj.c2466 (Published 03 June 2010) Cite this as: BMJ 2010;340:c2466
- Fati Nourhashemi, geriatrician123,
- Sandrine Andrieu, epidemiologist1234,
- Sophie Gillette-Guyonnet, research worker123,
- Bruno Giraudeau, statistician567,
- Christelle Cantet, statistician23,
- Nicola Coley, research worker23,
- Bruno Vellas, geriatrician123
- on behalf of the PLASA Group
- 1Gérontopôle, CMRR, Toulouse, France
- 2Inserm U558, Toulouse, France
- 3University of Toulouse III, France
- 4Department of Epidemiology and Public Health, Toulouse University Hospital, France
- 5Inserm CIC-202, Tours, France
- 6François Rabelais University, Tours, France
- 7CHRU de Tours, France
- Correspondence to: F Nourhashemi, Service de Médecine Interne et de Gérontologie Clinique, CHU Purpan-Casselardit, 170 chemin de Casselardit, 31059 Toulouse, France
- Accepted 12 April 2010
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.
We thank the investigators from the following hospitals for help with data collection for the PLASA study: Albi General Hospital: Alain Quinçon; Ales General Hospital: Liliane Peju; Anger University Hospital: Gilles Berrut; Annecy General Hospital: Francoise Picot; Bar Le Duc General Hospital: Gabrielle De Guio; Bordeaux University Hospital: Muriel Rainfray; Brest University Hospital: Armelle Gentric; Carcassonne General Hospital: Christian Tannier; Carvin General Hospital: Nathalie Taillez; Chambéry General Hospital: Françoise Declippeleir, Claude Hohn; Champcueil General Hospital: Marie Françoise Maugourd; Dieppe General Hospital: Thierry Pesque; Elbeuf General Hospital: Thibault Simon; Grasse General Hospital: Jacques Ribiere; Grenoble University Hospital: Alain Franco; Lannemezan General Hospital: Serge Bordes; Lavaur General Hospital: Françoise De Pemille; Le Havre General Hospital: Isabelle Landrin; Lens General Hospital: Olivier Senechal; Lille University Hospital: Jean Roche, Florence Pasquier; Lyon University Hospital: Marc Bonnefoy; Marseille University Hospital: Bernard Michel; Montpellier University Hospital: Claude Jeandel, Jacques Touchon; Nice General Hospital: Jean Yves Giordana; Nice University Hospital: Patrice Brocker, Philippe Robert, Olivier Guerin; Nimes General Hospital: Denise Strubel; Niort General Hospital: Jean Albert Chaumier; Paris General Hospital: Bernard Durand-Gasselin; Paris General Hospital: Michel Samson; Paris University Hospital: Joel Belmin, Sylvie Legrain, Anne Sophie Rigaud, Laurent Teillet, Marc Verny, Sylvie Pariel; Pau General Hospital: François de la Fournière; Plaisir General Hospital: Olivier Drunat; Reims University Hospital: François Blanchard; Rennes University Hospital: Pierre Jouanny; Roubaix General Hospital: Pierre Forzy; Rouen General Hospital: Moynot; Rouen University Hospital: Philippe Chassagne, Didier Hannequin, Frédérique Dugny, Caroline Levasseur; Saint Dizier General Hospital: Anne Aubertin; Sezanne General Hospital: Elisabeth Quignard; Valenciennes General Hospital: Pascale Leurs; Vannes General Hospital: Christian Le Provost; Villejuif General Hospital: Dorin Feteanu, Christophe Trivalle; Wasquehal General Hospital: Frigard. We also thank M C Cazes for administrative support and Julie Léger for her statistical help. The CD-ROM was produced with financial support from the French Ministry of Health.
Contributors: FN, SA, SG-G, and BV conceived and designed the study. SG-G, SA, and FN acquired the data. SA, FN, SG-G, CC, BG, and BV analysed and interpreted the data. FN, SA, NC, and BV prepared the manuscript. BG provided information on independent statistical analysis. All authors critically reviewed the manuscript and approved the final version to be published, had full access to all data in the study, and take responsibility for the integrity of the data and the accuracy of the data analysis. FN, SA, SG-G, and BV are guarantors.
Funding: This study was supported by a grant from the French Ministry of Health (PHRC 02-006-01). The sponsor had no role in the study.
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.
Ethical approval: This study was approved by the institutional review board and ethics committee of Toulouse University (France).
Data sharing: No additional data available.
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