Specific Care and Assistance Plan for Alzheimer's Disease (PLASA)
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| ClinicalTrials.gov Identifier: NCT00480220 |
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Recruitment Status :
Completed
First Posted : May 30, 2007
Last Update Posted : August 19, 2015
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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 or disease | Intervention/treatment | Phase |
|---|---|---|
| Alzheimer's Disease | Procedure: Global care and support program | Not Applicable |
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 (Clinical Trial) |
| Actual Enrollment : | 1200 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | None (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 |
| Study Start Date : | August 2003 |
| Actual Primary Completion Date : | August 2007 |
| Actual Study Completion Date : | August 2007 |
| Arm | Intervention/treatment |
|---|---|
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Experimental: 1
Specific Intervention as Global care and support program
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Procedure: Global care and support program |
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No Intervention: 2
'No specific intervention'
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- 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 ]
- 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 ]
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| Ages Eligible for Study: | 65 Years and older (Older Adult) |
| Sexes Eligible for Study: | 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00480220
Show 40 study locations
| Study Director: | VELLAS Bruno, PD PhD | University Hospital, Toulouse |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | University Hospital, Toulouse |
| ClinicalTrials.gov Identifier: | NCT00480220 |
| Other Study ID Numbers: |
0200601 PHRC ( Other Grant/Funding Number: 2001 and 2006 ) |
| First Posted: | May 30, 2007 Key Record Dates |
| Last Update Posted: | August 19, 2015 |
| Last Verified: | August 2015 |
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specific care assistance plan Alzheimer's disease |
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Alzheimer Disease Dementia Brain Diseases Central Nervous System Diseases Nervous System Diseases |
Tauopathies Neurodegenerative Diseases Neurocognitive Disorders Mental Disorders |