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

August 18, 2015 updated by: University Hospital, Toulouse

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

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

1200

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

65 years and older (Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
Specific Intervention as Global care and support program
Procedure: Global care and support program
No Intervention: 2
'No specific intervention'

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
2 years

Secondary Outcome Measures

Outcome Measure
Time Frame
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
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Toulouse

Investigators

  • Study Director: VELLAS Bruno, PD PhD, University Hospital, Toulouse

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2003

Primary Completion (Actual)

August 1, 2007

Study Completion (Actual)

August 1, 2007

Study Registration Dates

First Submitted

May 29, 2007

First Submitted That Met QC Criteria

May 29, 2007

First Posted (Estimate)

May 30, 2007

Study Record Updates

Last Update Posted (Estimate)

August 19, 2015

Last Update Submitted That Met QC Criteria

August 18, 2015

Last Verified

August 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0200601
  • PHRC (2001/1939)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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