Alzheimer's DiseasePLASANCT00480220
Specific Care and Assistance Plan for Alzheimer's Disease
A study testing Global care and support program in people with Alzheimer's Disease, run by University Hospital, Toulouse at 40 sites in France.
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 . Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Alzheimer's Disease
- What is being tested?
- Global care and support program
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,200 participants
- Where
- 40 sitesFrance
- Study dates
- Aug 2003to Aug 2007
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
40 sites in 1 country.
40 sites in 1 country
France40 sites
Hospital
Albi, 81
Hospital Center
Alès, 30
University Hospital
Angers, 49033
Hospital
Annecy, 74
Hospital Center
Bar-le-Duc, 55
University Hospital
Brest, 29
Hospital Center
Carcassonne, 11
Service de Gérontologie
Carvin, 62
Hospital
Chambéry, 73
Georges Clémenceau Hospital
Champcueil, 91
Hospital Center
Grasse, 06
University Hospital
Grenoble, 38043
Hôpital Charles Foix - La Triade
Ivry-sur-Seine, 94206
Hospital Center
Lannemezan, 65
Hospital Center
Lavaur, 81
Hospital
Lens, 62
University Hospital
Lille, 59
Hospital Center
Louviers, 27
University Hospital
Lyon, 69
University Hospital Sainte Marguerite
Marseille, 13
University Hospital
Montpellier, 34295
University Hospital
Nice, 06003
University Hospital
Nîmes, 30
Hospital Center
Niort, 79
Hospital Bichat - Claude Bernard
Paris, 75
Hospital Center Notre Dame du Bon Secours
Paris, 75
University Hospital BROCA - La Rochefoucauld
Paris, 75
University Hospital Pitié-Salpétrière
Paris, 75
University Hospital Sainte Perrine
Paris, 75
Hospital center
Plaisir, 78
University Hospital
Reims, 51092
Hospital Center
Roubaix, 59
University Hospital
Rouen, 76
Hospital Center
Saint-Dizier, 52
Hospital Center
Sézanne, 51
University Hospital, Hôpital Xavier Arnozan
Toulouse, 31
University Hospital
Toulouse, 31
Hospital
Valenciennes, 59
Hospital Center
Villejuif, 94800
Hospital
Wasquehal, 59
About this study
Official title: 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).
Read the 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.
- Conditions
- Alzheimer's Disease
- Being tested
- Global care and support program
- Keywords
- specific care, assistance plan, Alzheimer's disease
- Medical subject headings
- Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Global care and support programProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Specific Intervention as Global care and support program Receives: Procedure: Global care and support program |
| 2 | No intervention | 'No specific intervention' |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 2 years
Secondary outcomes (1)
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).
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 May 2007 (estimated)
- Study startAug 2003
- Primary completionAug 2007
- Study completionAug 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Alzheimer's DiseaseStudies of the same condition, open and under way.
- More trials run by University Hospital, ToulouseThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,200 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Toulouse
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- VELLAS Bruno, PD PhD, Study director, University Hospital, Toulouse
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00480220
- Sponsor's protocol ID
- 0200601
- Other IDs
- PHRC
- Acronym
- PLASA
- Status last verified
- Aug 2015
- First submitted
- 29 May 2007
- Last updated
- 19 Aug 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
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. doi: 10.1001/jama.295.18.2148.
PubMed 16684985Teri 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. doi: 10.1001/jama.290.15.2015.
PubMed 14559955Teri L, Logsdon RG, McCurry SM. Nonpharmacologic treatment of behavioral disturbance in dementia. Med Clin North Am. 2002 May;86(3):641-56, viii. doi: 10.1016/s0025-7125(02)00006-8.
PubMed 12168563Vickrey 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. doi: 10.7326/0003-4819-145-10-200611210-00004.
PubMed 17116916Nourhashemi F, Andrieu S, Gillette-Guyonnet S, Giraudeau B, Cantet C, Coley N, Vellas B; PLASA Group. Effectiveness of a specific care plan in patients with Alzheimer's disease: cluster randomised trial (PLASA study). BMJ. 2010 Jun 3;340:c2466. doi: 10.1136/bmj.c2466.
PubMed 20522656Nourhashemi F, Gillette-Guyonnet S, Andrieu S, Rolland Y, Ousset PJ, Vellas B; PLASA group. A randomized trial of the impact of a specific care plan in 1120 Alzheimer's patients (PLASA Study) over a two-year period: design and baseline data. J Nutr Health Aging. 2008 Apr;12(4):263-71. doi: 10.1007/BF02982632.
PubMed 18373036
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Specific Care and Assistance Plan for Alzheimer's Disease: Impact Study on Disease Progression and Management Modalities
- ClinicalTrials.gov ID
- NCT00480220
- Acronym / sponsor ID
- PLASA / 0200601
- Conditions
- Alzheimer's Disease
- Keywords
- specific care, assistance plan, Alzheimer's disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,200 participants (actual)
- Lead sponsor
- University Hospital, ToulouseUniversity, hospital or other
- Study start
- Aug 2003
- Primary completion
- Aug 2007 (actual)
- Study completion
- Aug 2007 (actual)
- First posted
- 30 May 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Procedure: Global care and support programSpecific Intervention as Global care and support program |
| 2 | No intervention | –'No specific intervention' |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Global care and support program | Procedure or surgery | 1 |
Primary outcome
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
1 secondary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2015.
- Background: PubMed 16684985Callahan 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. doi: 10.1001/jama.295.18.2148.
- Background: PubMed 14559955Teri 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. doi: 10.1001/jama.290.15.2015.
- Background: PubMed 12168563Teri L, Logsdon RG, McCurry SM. Nonpharmacologic treatment of behavioral disturbance in dementia. Med Clin North Am. 2002 May;86(3):641-56, viii. doi: 10.1016/s0025-7125(02)00006-8.
- Background: PubMed 17116916Vickrey 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. doi: 10.7326/0003-4819-145-10-200611210-00004.
- Derived from this study: PubMed 20522656Nourhashemi F, Andrieu S, Gillette-Guyonnet S, Giraudeau B, Cantet C, Coley N, Vellas B; PLASA Group. Effectiveness of a specific care plan in patients with Alzheimer's disease: cluster randomised trial (PLASA study). BMJ. 2010 Jun 3;340:c2466. doi: 10.1136/bmj.c2466.
- Derived from this study: PubMed 18373036Nourhashemi F, Gillette-Guyonnet S, Andrieu S, Rolland Y, Ousset PJ, Vellas B; PLASA group. A randomized trial of the impact of a specific care plan in 1120 Alzheimer's patients (PLASA Study) over a two-year period: design and baseline data. J Nutr Health Aging. 2008 Apr;12(4):263-71. doi: 10.1007/BF02982632.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
VELLAS Bruno, PD PhD study director
University Hospital, Toulouse
40 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Global care and support program in people with Alzheimer's Disease, run by University Hospital, Toulouse at 40 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Aug 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 40 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00480220, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Aug 2015.