Specific Care and Assistance Plan for Alzheimer's Disease
PLASA
2 other identifiers
interventional
1,200
1 country
40
Brief Summary
The main objective of this work is to assess the feasibility and efficacy of a specific Care and Assistance Plan for Alzheimer's disease (PLASA). The main outcome measure selected is incapacity in carrying out the basic activities of daily living, evaluated by the ADCS-ADL scale . The PLASA was developed by a working group appointed by the Direction Générale de la Santé as part of the government programme of action on Alzheimer's disease (October 2001, Ministère de l'Emploi et de la Solidarité).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Aug 2003
Longer than P75 for not_applicable
40 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2003
CompletedFirst Submitted
Initial submission to the registry
May 29, 2007
CompletedFirst Posted
Study publicly available on registry
May 30, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2007
CompletedAugust 19, 2015
August 1, 2015
4 years
May 29, 2007
August 18, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Evaluate the efficacy of the specific care and assistance plan for Alzheimer's disease in a study randomised within each centre. The main aim of the care plan is to reduce loss of independence.
2 years
Secondary Outcomes (1)
Impact of the care and assistance plan: - on the mode of the patient's admission to an institution - on utilization of assistance, support and healthcare services (RUD questionnaire) - and on overall clinical evaluation of change (ADCS-CGIC).
2 years
Study Arms (2)
1
EXPERIMENTALSpecific Intervention as Global care and support program
2
NO INTERVENTION'No specific intervention'
Interventions
Eligibility Criteria
You may qualify if:
- patient seen in consultation in one of the centres participating in the study
- patient with probable or possible AD according to NINCDS-ADRDA criteria
- patient with an MMSE score between 12 and 26 (mild to moderate disease)
- patient capable of understanding and responding to the evaluations made
- patient who is not confined to bed or chair
- patient living at home with an informal caregiver
- informed consent of the patient (or legal representative) and of the caregiver agreeing to take part in the study.
You may not qualify if:
- patient with an MMSE score of less than 12 or over 26
- patient incapable of understanding and responding to the evaluations made
- patient confined to bed or chair
- patient living at home without an informal carer or in an institution
- patient with a concomitant disorder threatening the vital prognosis at two years
- patient with a dementia other than AD
- patient already included in another research programme.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (40)
Hospital
Albi, 81, France
Hospital Center
Alès, 30, France
University Hospital
Angers, 49033, France
Hospital
Annecy, 74, France
Hospital Center
Bar-le-Duc, 55, France
University Hospital
Brest, 29, France
Hospital Center
Carcassonne, 11, France
Service de Gérontologie
Carvin, 62, France
Hospital
Chambéry, 73, France
Georges Clémenceau Hospital
Champcueil, 91, France
Hospital Center
Grasse, 06, France
University Hospital
Grenoble, 38043, France
Hôpital Charles Foix - La Triade
Ivry-sur-Seine, 94206, France
Hospital Center
Lannemezan, 65, France
Hospital Center
Lavaur, 81, France
Hospital
Lens, 62, France
University Hospital
Lille, 59, France
Hospital Center
Louviers, 27, France
University Hospital
Lyon, 69, France
University Hospital Sainte Marguerite
Marseille, 13, France
University Hospital
Montpellier, 34295, France
University Hospital
Nice, 06003, France
Hospital Center
Niort, 79, France
University Hospital
Nîmes, 30, France
Hospital Bichat - Claude Bernard
Paris, 75, France
Hospital Center Notre Dame du Bon Secours
Paris, 75, France
University Hospital BROCA - La Rochefoucauld
Paris, 75, France
University Hospital Pitié-Salpétrière
Paris, 75, France
University Hospital Sainte Perrine
Paris, 75, France
Hospital center
Plaisir, 78, France
University Hospital
Reims, 51092, France
Hospital Center
Roubaix, 59, France
University Hospital
Rouen, 76, France
Hospital Center
Saint-Dizier, 52, France
Hospital Center
Sézanne, 51, France
University Hospital, Hôpital Xavier Arnozan
Toulouse, 31, France
University Hospital
Toulouse, 31, France
Hospital
Valenciennes, 59, France
Hospital Center
Villejuif, 94800, France
Hospital
Wasquehal, 59, France
Related Publications (6)
Callahan CM, Boustani MA, Unverzagt FW, Austrom MG, Damush TM, Perkins AJ, Fultz BA, Hui SL, Counsell SR, Hendrie HC. Effectiveness of collaborative care for older adults with Alzheimer disease in primary care: a randomized controlled trial. JAMA. 2006 May 10;295(18):2148-57. doi: 10.1001/jama.295.18.2148.
PMID: 16684985BACKGROUNDTeri L, Gibbons LE, McCurry SM, Logsdon RG, Buchner DM, Barlow WE, Kukull WA, LaCroix AZ, McCormick W, Larson EB. Exercise plus behavioral management in patients with Alzheimer disease: a randomized controlled trial. JAMA. 2003 Oct 15;290(15):2015-22. doi: 10.1001/jama.290.15.2015.
PMID: 14559955BACKGROUNDTeri L, Logsdon RG, McCurry SM. Nonpharmacologic treatment of behavioral disturbance in dementia. Med Clin North Am. 2002 May;86(3):641-56, viii. doi: 10.1016/s0025-7125(02)00006-8.
PMID: 12168563BACKGROUNDVickrey BG, Mittman BS, Connor KI, Pearson ML, Della Penna RD, Ganiats TG, Demonte RW Jr, Chodosh J, Cui X, Vassar S, Duan N, Lee M. The effect of a disease management intervention on quality and outcomes of dementia care: a randomized, controlled trial. Ann Intern Med. 2006 Nov 21;145(10):713-26. doi: 10.7326/0003-4819-145-10-200611210-00004.
PMID: 17116916BACKGROUNDNourhashemi F, Andrieu S, Gillette-Guyonnet S, Giraudeau B, Cantet C, Coley N, Vellas B; PLASA Group. Effectiveness of a specific care plan in patients with Alzheimer's disease: cluster randomised trial (PLASA study). BMJ. 2010 Jun 3;340:c2466. doi: 10.1136/bmj.c2466.
PMID: 20522656DERIVEDNourhashemi F, Gillette-Guyonnet S, Andrieu S, Rolland Y, Ousset PJ, Vellas B; PLASA group. 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. J Nutr Health Aging. 2008 Apr;12(4):263-71. doi: 10.1007/BF02982632.
PMID: 18373036DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
VELLAS Bruno, PD PhD
University Hospital, Toulouse
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 29, 2007
First Posted
May 30, 2007
Study Start
August 1, 2003
Primary Completion
August 1, 2007
Study Completion
August 1, 2007
Last Updated
August 19, 2015
Record last verified: 2015-08