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Specific Care and Assistance Plan for Alzheimer's Disease

Information source: University Hospital, Toulouse
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Alzheimer's Disease

Intervention: Global care and support program (Procedure)

Phase: N/A

Status: Completed

Sponsored by: University Hospital, Toulouse

Official(s) and/or principal investigator(s):
VELLAS Bruno, PD PhD, Study Director, Affiliation: University Hospital, Toulouse

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).

Clinical Details

Official title: Specific Care and Assistance Plan for Alzheimer's Disease: Impact Study on Disease Progression and Management Modalities

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Primary outcome: 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.

Secondary outcome: 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).

Detailed description: It is estimated that at the present time about 50% of dependence in the elderly is related to dementias. Alzheimer's disease is the most common of these, and there are 100 000 new cases in France every year (Girard Report). Very often, once the diagnosis has been established these persons do not receive regular, codified follow-up, whereas Alzheimer's disease is a chronic disease which progresses over several years and leads to a variety of complications which must be identified and managed. 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.

Eligibility

Minimum age: 65 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria:

- 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. Exclusion Criteria:

- 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.

Locations and Contacts

Hospital, Albi 81, France

Hospital Center, Ales 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, Chambery 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

University Hospital, Nimes 30, France

Hospital Center, Niort 79, 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, Sezanne 51, France

University Hospital, Toulouse 31, France

University Hospital, Hôpital Xavier Arnozan, Toulouse 31, France

Hospital, Valenciennes 59, France

Hospital Center, Villejuif 94800, France

Hospital, Wasquehal 59, France

Additional Information

Related publications:

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.

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.

Teri L, Logsdon RG, McCurry SM. Nonpharmacologic treatment of behavioral disturbance in dementia. Med Clin North Am. 2002 May;86(3):641-56, viii. Review.

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.

Starting date: August 2003
Last updated: August 18, 2015

Page last updated: August 23, 2015

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