Specific Care and Assistance Plan for Alzheimer's Disease
NCT ID: NCT00480220
Last Updated: 2015-08-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
1200 participants
INTERVENTIONAL
2003-08-31
2007-08-31
Brief Summary
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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).
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Detailed Description
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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).
Methods The multicentre prospective study will be randomised within each centre. Study population: 1200 patients will be recruited in 20 French university hospitals and 40 general hospitals.
Inclusion criteria: Patients presenting mild to moderate Alzheimer's disease diagnosed by the NINCDS-ADRDA criteria (MMSE between 12 and 26), living at home and with an identified principal caregiver.
Randomisation and patient follow-up: After randomisation within each centre (specialised department of the university or general hospital), half of the patients will be managed according to the PLASA (group A). The other patients will receive the usual management of the centres (group B).
The PLASA includes detailed evaluation of the patient's cognitive and non-cognitive function, regular and standardised follow-up, management of complications and the setting up of assistance and support services according to common guidelines. As part of the PLASA, patients will be systematically seen in consultation every six months.
Data collection: In group A, data will be collected during six-monthly consultations for the duration of the study (T0, T6, T12, T18, T24). In group B, data will be collected during consultations at T0, T12 and T24. The coordinating centre (Toulouse) will contact every 6 months (T6, T12, T18, T24), by post or by telephone, the principal caregiver for collection of intermediate data in both groups. These data include evaluation of activities of daily living (ADCS-ADL), utilization of support and care services (RUD ), as well as subjective assessment of disease severity (ADCS-CGIC ). The patient's quality of life will also be evaluated in both groups at T0, T12 and T24.
Statistical analysis: 1200 subjects are needed to reveal a 30% decrease in incapacities in activities of daily living in the group of patients followed according to the PLASA.
Bivariate analysis will be carried out using the standard tests for this type of study (chi-squared test and Student's t test). The efficacy of the PLASA will be assessed by multivariate analysis, taking potential confounders into account.
Expected results: This project should contribute to better long-term management of patients with Alzheimer's disease and should reduce the burden on families.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
NONE
Study Groups
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1
Specific Intervention as Global care and support program
Global care and support program
2
'No specific intervention'
No interventions assigned to this group
Interventions
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Global care and support program
Eligibility Criteria
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Inclusion Criteria
* 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.
Exclusion Criteria
* 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.
65 Years
ALL
No
Sponsors
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University Hospital, Toulouse
OTHER
Responsible Party
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Principal Investigators
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VELLAS Bruno, PD PhD
Role: STUDY_DIRECTOR
University Hospital, Toulouse
Locations
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Hospital
Albi, , France
Hospital Center
Alès, , France
University Hospital
Angers, , France
Hospital
Annecy, , France
Hospital Center
Bar-le-Duc, , France
University Hospital
Brest, , France
Hospital Center
Carcassonne, , France
Service de Gérontologie
Carvin, , France
Hospital
Chambéry, , France
Georges Clémenceau Hospital
Champcueil, , France
Hospital Center
Grasse, , France
University Hospital
Grenoble, , France
Hôpital Charles Foix - La Triade
Ivry-sur-Seine, , France
Hospital Center
Lannemezan, , France
Hospital Center
Lavaur, , France
Hospital
Lens, , France
University Hospital
Lille, , France
Hospital Center
Louviers, , France
University Hospital
Lyon, , France
University Hospital Sainte Marguerite
Marseille, , France
University Hospital
Montpellier, , France
University Hospital
Nice, , France
Hospital Center
Niort, , France
University Hospital
Nîmes, , France
Hospital Bichat - Claude Bernard
Paris, , France
Hospital Center Notre Dame du Bon Secours
Paris, , France
University Hospital BROCA - La Rochefoucauld
Paris, , France
University Hospital Pitié-Salpétrière
Paris, , France
University Hospital Sainte Perrine
Paris, , France
Hospital center
Plaisir, , France
University Hospital
Reims, , France
Hospital Center
Roubaix, , France
University Hospital
Rouen, , France
Hospital Center
Saint-Dizier, , France
Hospital Center
Sézanne, , France
University Hospital, Hôpital Xavier Arnozan
Toulouse, , France
University Hospital
Toulouse, , France
Hospital
Valenciennes, , France
Hospital Center
Villejuif, , France
Hospital
Wasquehal, , France
Countries
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References
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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.
Teri 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.
Teri 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.
Vickrey 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.
Nourhashemi 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.
Nourhashemi 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.
Other Identifiers
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PHRC
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
0200601
Identifier Type: -
Identifier Source: org_study_id
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