Specific Care and Assistance Plan for Alzheimer's Disease (PLASA)

This study has been completed.
Sponsor:
Information provided by:
University Hospital, Toulouse
ClinicalTrials.gov Identifier:
NCT00480220
First received: May 29, 2007
Last updated: December 28, 2007
Last verified: December 2007
  Purpose

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).


Condition Intervention
Alzheimer's Disease
Procedure: Global care and support program
Other: No specific intervention

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: Specific Care and Assistance Plan for Alzheimer's Disease: Impact Study on Disease Progression and Management Modalities

Resource links provided by NLM:


Further study details as provided by University Hospital, Toulouse:

Primary Outcome Measures:
  • 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. [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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). [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Enrollment: 1200
Study Start Date: August 2003
Study Completion Date: August 2007
Primary Completion Date: August 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Specific Intervention
Procedure: Global care and support program
No Intervention: 2
No specific intervention
Other: No specific intervention

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

Ages Eligible for Study:   65 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • patient seen in consultation in one of the centres participating in the study
  • aged over 65 years
  • 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 aged less than 65 years
  • 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00480220

Locations
France
Hospital
Albi, France, 81
Hospital Center
Ales, France, 30
University Hospital
Angers, France, 49033
Hospital
Annecy, France, 74
Hospital Center
Bar Le Duc, France, 55
University Hospital
Brest, France, 29
Hospital Center
Carcassonne, France, 11
Service de Gérontologie
Carvin, France, 62
Hospital
Chambery, France, 73
Georges Clémenceau Hospital
Champcueil, France, 91
Hospital Center
Grasse, France, 06
University Hospital
Grenoble, France, 38043
Hôpital Charles Foix - La Triade
Ivry-sur-seine, France, 94206
Hospital Center
Lannemezan, France, 65
Hospital Center
Lavaur, France, 81
Hospital
Lens, France, 62
University Hospital
Lille, France, 59
Hospital Center
Louviers, France, 27
University Hospital
Lyon, France, 69
University Hospital Sainte Marguerite
Marseille, France, 13
University Hospital
Montpellier, France, 34295
University Hospital
Nice, France, 06003
University Hospital
Nimes, France, 30
Hospital Center
Niort, France, 79
Hospital Center Notre Dame du Bon Secours
Paris, France, 75
University Hospital Sainte Perrine
Paris, France, 75
University Hospital Pitié-Salpétrière
Paris, France, 75
Hospital Bichat - Claude Bernard
Paris, France, 75
University Hospital BROCA - La Rochefoucauld
Paris, France, 75
Hospital center
Plaisir, France, 78
University Hospital
Reims, France, 51092
Hospital Center
Roubaix, France, 59
University Hospital
Rouen, France, 76
Hospital Center
Saint Dizier, France, 52
Hospital Center
Sezanne, France, 51
University Hospital, Hôpital Xavier Arnozan
Toulouse, France, 31
University Hospital
Toulouse, France, 31
Hospital
Valenciennes, France, 59
Hospital Center
Villejuif, France, 94800
Hospital
Wasquehal, France, 59
Sponsors and Collaborators
University Hospital, Toulouse
Investigators
Study Director: VELLAS Bruno, PU-PH University Hospital, Toulouse
  More Information

Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: LLAU ME, UHToulouse
ClinicalTrials.gov Identifier: NCT00480220     History of Changes
Other Study ID Numbers: 0200601, PHRC 2001 and PHRC 2006
Study First Received: May 29, 2007
Last Updated: December 28, 2007
Health Authority: France: Ministry of Health

Keywords provided by University Hospital, Toulouse:
specific care
assistance plan
Alzheimer's disease

Additional relevant MeSH terms:
Alzheimer Disease
Brain Diseases
Central Nervous System Diseases
Delirium, Dementia, Amnestic, Cognitive Disorders
Dementia
Mental Disorders
Nervous System Diseases
Neurodegenerative Diseases
Tauopathies

ClinicalTrials.gov processed this record on October 23, 2014