Specific Care and Assistance Plan for Alzheimer's Disease: Impact Study on Disease Progression and Management Modalities
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 1,200
- Locations
- 40
- Primary Endpoint
- 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.
Study Overview
Brief 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).
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Supportive Care
- Masking
- None
Eligibility Criteria
- Ages
- 65 Years to — (Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
1
Specific Intervention as Global care and support program
Intervention: Global care and support program (Procedure)
2
'No specific intervention'
Outcomes
Primary Outcomes
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
Secondary Outcomes
- 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)