Specific Care and Assistance Plan for Alzheimer's Disease

Alzheimer's Disease Clinical Trial

— PLASA  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00480220
• Other study ID #: 0200601
• Secondary ID: PHRC
• Status: Completed
• Phase: N/A
• First received: May 29, 2007
• Last updated: August 18, 2015
• Start date: August 2003
• Est. completion date: August 2007

Study information

• Verified date: August 2015
• Source: University Hospital, Toulouse
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Ministry of Health
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1200
• Est. completion date: August 2007
• Est. primary completion date: August 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 65 Years and older

Eligibility

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.

Study Design

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

Related Conditions & MeSH terms

• Alzheimer Disease
• Alzheimer's Disease

Intervention

Procedure:
• Global care and support program

Locations

Country	Name	City	State
France	Hospital	Albi
France	Hospital Center	Ales
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	Chambery
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	University Hospital	Nimes
France	Hospital Center	Niort
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	Sezanne
France	University Hospital	Toulouse
France	University Hospital, Hôpital Xavier Arnozan	Toulouse
France	Hospital	Valenciennes
France	Hospital Center	Villejuif
France	Hospital	Wasquehal

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Toulouse

Country where clinical trial is conducted

France, 

References & Publications (4)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No