The Journal of Nutrition Health and Aging

, Volume 12, Issue 4, pp 263–271 | Cite as

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

  • F. Nourhashemi
  • S. Gillette-Guyonnet
  • S. Andrieu
  • Y. Rolland
  • P. -J. Ousset
  • B. Vellas
  • The PLASA Group
Clinical Trials and Aging

Abstract

Objectives: To describe the design and baseline patient characteristics of a multicomponent specific care and assistance plan (PLASA) study in Alzheimer’s Disease (AD). The study is designed to evaluate the effect of PLASA in AD primarily looking at change in functional capacity.Design: Two-years prospective cluster randomized controlled trial comparing PLASA and usual care. Setting: Forty-nine hospitals in France.Participants: 1120 community-dwelling AD.Intervention: Patients in the intervention group are evaluated bi-annually using a standardized comprehensive global assessment. In the case of decline in any one domain a standardized study protocol recommends specific physician directed intervention in addition to information and training for the caregiver.Measurements: Alzheimer Disease Cooperative Study-Activities of Daily Living scale, Resource Utilization in Dementia scale, Clinical Global Impression of Change.Results: At baseline, the two groups were similar regarding patient and caregiver characteristics. The mean patient age was 79.61 + 5.72 years and the mean MMSE 19.73 + 4.01 for the whole cohort. Time since dementia diagnosis was about 1.37 + 1.65 years in the whole cohort. Almost a third of the patients lived alone at baseline. Mean monthly time spent in caregiving in the whole cohort was 52.70 + 71.83 hours for instrumental activities and 17.73 + 51.38 hours for basic activities.Conclusion: Persons with dementia suffer different losses at different stages of the disease and therefore accurate assessment of abilities and losses is critical to assist the person in planning for their future and for care needs. The PLASA intervention study is ongoing with 2 year follow-up to be completed in 2007.

Key words

Alzheimer’s disease cluster randomized trial specific care plan 

Preview

Unable to display preview. Download preview PDF.

Unable to display preview. Download preview PDF.

References

  1. 1.
    Ferri CP, Prince M, Brayne C, et al. Global prevalence of dementia: a Delphi consensus study. Lancet 2005; 336: 2112–2117.Google Scholar
  2. 2.
    Moore MJ, Zhu CW, Clipp EC. Informal costs of dementia care: estimates from the National Longitudinal Caregiver Study. J Gerontol B Psychol Sci Soc Sci 2001; 56: S219-S228.PubMedGoogle Scholar
  3. 3.
    Sorensen S, Duberstein P, Gill D, Pinquart M. Dementia care: mental health effects, intervention strategies, and clinical implications. Lancet Neurol 2006; 5: 961–973.PubMedCrossRefGoogle Scholar
  4. 4.
    Starkstein SE, Mizrahi R. Depression in Alzheimer’s disease. Expert Rev Neurother 2006, 6: 887–895.PubMedCrossRefGoogle Scholar
  5. 5.
    Bedart M, Molloy DW, Bell R, Lever JA. Determinants and detection of low body mass index in community dwelling adults with Alzheimer’s disease. Int Psychogeriatr 2000; 12: 87–98.CrossRefGoogle Scholar
  6. 6.
    Gillette Guyonnet S, Abellan Van Kan G, Alix E et al. Weight loss and Alzheimer’s disease. J Nutr Health Aging 2007;11: 38–48.PubMedGoogle Scholar
  7. 7.
    Bullock R. Treatment of behavioural and psychiatric symptoms in dementia: implications of recent safety warnings. Curr Med Res Opin 2005; 21: 1–10.PubMedCrossRefGoogle Scholar
  8. 8.
    Rothman AA, Wagner EH. Chronic illness management: what is the role of primary care? Ann Intern Med 2003; 138: 256–261.PubMedGoogle Scholar
  9. 9.
    Gifford DR, Holloway RG, Frankel MR, Albright CL, Meyerson R, Griggs RC, Vickrey BG. Improving adherence to dementia guidelines through education and opinion leaders. A randomized, controlled trial. Ann Intern Med 1999; 131: 237–246.PubMedGoogle Scholar
  10. 10.
    Vickrey BG, Mittman BS, Connor KI et al. The effect of a disease management intervention on quality and outcomes of dementia care: a randomized, controlled trial. Ann Intern Med 2006; 145: 713–726.PubMedGoogle Scholar
  11. 11.
    Bass DM, Clark PA, Looman WJ, McCarthy CA, Eckert S. The Cleveland Alzheimer’s managed care demonstration: outcomes after 12 months of implementation. Gerontologist 2003; 43: 73–85.PubMedGoogle Scholar
  12. 12.
    Callahan CM, Boustani MA, Unverzagt FW et al. Effectiveness of collaborative care for older adults with Alzheimer disease in primary care: a randomised controlled trial. JAMA 2006; 295: 2148–2157.PubMedCrossRefGoogle Scholar
  13. 13.
    Dementia identification and assessment: guideline for primary care practitioners. Washington, DC and Oakbrook, Ill: US Dept of Veterans Affairs and University Health System Consortium; 1997.Google Scholar
  14. 14.
    Small GW, Rabins PV, Barry PP et al. Diagnosis and treatment of Alzheimer disease and related disorders. Consensus statement of the American Association for Geriatric Psychiatry, the Alzheimer’s Association, and the American Geriatrics Society. JAMA 1997; 278: 1363–1371.PubMedCrossRefGoogle Scholar
  15. 15.
    Patterson CJ, Gauthier S, Bergman H et al. The recognition, assessment and management of dementing disorders: conclusions from the Canadian Consensus Conference on Dementia. CMAJ 1999; 160 (12 Suppl): S1-S15.PubMedGoogle Scholar
  16. 16.
    Cummings JL, Frank JC., Cherry D et al. Guidelines for managing Alzheimer’s disease: part I. Assessment Am Fam Physician 2002; 65: 2263–2272.Google Scholar
  17. 17.
    Fillit H, Cummings J. Practice guidelines for the diagnosis and treatment of Alzheimer’s disease in a managed care setting: Part II--Pharmacologic therapy. Alzheimer’s Disease (AD) Managed Care Advisory Council. Manag Care Interface 2000;13: 51–56.PubMedGoogle Scholar
  18. 18.
    Harvey RJ. A review and commentary on a sample of 15 UK guidelines for the drug treatment of Alzheimer’s disease. Int JGeriatr Psychiatry 1999; 14: 249–256.CrossRefGoogle Scholar
  19. 19.
    American Psychiatric Association. Practice guideline for the treatment of patients with Alzheimer’s disease and other dementias of late life. Am J Psychiatry 1997; 154: 5–39.Google Scholar
  20. 20.
    Doody RS, Stevens JC, Beck C et al. Practice parameter: management of dementia (an evidence-based review). Report of the Quality Standards Subcommittee of the American Academy of Neurology. Neurology 2001; 56: 1154–1166.PubMedGoogle Scholar
  21. 21.
    McKhann G, Drachman D, Folstein M, Katzman R, Price D, Stadlan EM. Clinical diagnosis of Alzheimer’s disease: report of the N1NCDS-ADRDA Work Group under the auspices of Department of Health and Human Services Task Force on Alzheimer’s Disease. Neurology 1984; 34: 939–944.PubMedGoogle Scholar
  22. 22.
    Galasko D, Benett D, Sano M et al. An inventory to assess activities of daily living for clinical trials in Alzheimer’s disease. The Alzheimer’s Disease Cooperative Study. Alz Dis Assoc Dis 1997; 11: S33-S39.CrossRefGoogle Scholar
  23. 23.
    Wimo A, Nordberg G, Jansson W, Grafstrom M. Assessment of informal services to demented people with the RUD instrument. Int J Geriatr Psychiatry 2000; 15: 969–971.PubMedCrossRefGoogle Scholar
  24. 24.
    Schneider LS, Olin JT, Doody RS et al. Validity and reliability of the Alzheimer’s Disease Cooperative Study-Clinical Global Impression of Change. The Alzheimer’s Disease Cooperative Study. Alzheimer Dis Assoc Disord 1997;11 Suppl 2: S22-S32.PubMedCrossRefGoogle Scholar
  25. 25.
    Folstein MF, Folstein SE, McHugh PR. “Mini-mental state”. A practical method for grading the cognitive state of patients for the clinician. J Psychiatr Res 1975; 12: 189–198.PubMedCrossRefGoogle Scholar
  26. 26.
    Logsdon RG, Gibbons LE, McCurry SM, Teri L. Assessing quality of life in older adults with cognitive impairment. Psychosom Med 2002; 64: 510–509.PubMedGoogle Scholar
  27. 27.
    Katz S, Ford AB, Moskowitz RW, et al. The index of ADL: A standardized measure of biological and psychosocial function. JAMA 1963; 185: 914–919.PubMedGoogle Scholar
  28. 28.
    Lawton MP, Brody EM. Assessment of older people: self-maintaining and instrumental activities of daily living. Gerontologist 1969; 9: 179–186.PubMedGoogle Scholar
  29. 29.
    Vellas B, Villars H, Abellan et al. Overview of the MNA--Its history and challenges. J Nutr Health Aging 2006; 10: 456–65.PubMedGoogle Scholar
  30. 30.
    Cummings JL, Mega M, Gray R, Rosenberg-Thompson S, Carusi DA, Gornbein J. The Neuropsychiatrie Inventory: comprehensive assessment of psychopathology in dementia. Neurology 1994; 44: 2308–2314.PubMedGoogle Scholar
  31. 31.
    Vellas B, Wayne SJ, Romero L, Baumgartner RN, Rubenstein LZ, Garry PJ. One-leg balance is an important predictor of injurious falls in older persons. J Am Geriatr Soc 1997; 45: 735–738.PubMedGoogle Scholar
  32. 32.
    Zarit SH, Todd PA, Zarit JM. Subjective burden of husbands and wives as caregivers: a longitudinal study. Gerontologist 1986; 26: 260–266.PubMedGoogle Scholar
  33. 33.
    Pacala JT, Boult C, Hepburn KW et al. Case management of older adults in health maintenance organizations. J Am Geriatr Soc 1995; 43: 538–542.PubMedGoogle Scholar
  34. 34.
    Waldemar G, Dubois B, Emre M et al. Recommendations for the diagnosis and management of Alzheimer’s disease and other disorders associated with dementia: EFNS guideline. Eur J Neurol. 2007;14: e1–26.PubMedCrossRefGoogle Scholar
  35. 35.
    Lyketsos CG, Colenda CC, Beck C et al. Position statement of the American Association for Geriatric Psychiatry regarding principles of care for patients with dementia resulting from Alzheimer disease. Am J Geriatr Psychiatry 2006;14: 561–572.PubMedCrossRefGoogle Scholar
  36. 36.
    Vellas B, Gauthier S, Allain H et al. Consensus statement on dementia of Alzheimer type in the severe stage. J Nutr Health Aging 2005; 9: 330–338.PubMedGoogle Scholar
  37. 37.
    Alexopoulos GS, Jeste DV, Chung H, Carpenter D, Ross R, Docherty JP The expert consensus guideline series. Treatment of dementia and its behavioral disturbances. Introduction: methods, commentary, and summary. Postgrad Med. 2005; Spec No: 6–22.Google Scholar
  38. 38.
    Sörensen S, Duberstein P, Pinquart M. Dementia care: mental health effects, intervention strategies, and clinical implications. Lancet Neurol 2006; 5: 961–973.PubMedCrossRefGoogle Scholar
  39. 39.
    Sink KM, Holden KF, Yaffe K. Pharmacological treatment of neuropsychiatric symptoms of dementia: a review of the evidence. JAMA 2005; 293: 596–608.PubMedCrossRefGoogle Scholar
  40. 40.
    AGS Clinical Practice Committee. Guidelines abstracted from the American Academy of Neurology’s Dementia Guidelines for Early Detection, Diagnosis, and Management of Dementia. J Am Geriatr Soc 2003; 51: 869–873.CrossRefGoogle Scholar
  41. 41.
    Mittelman MS, Ferris SH, Shulman E, Steinberg G, Levin B. A family intervention to delay nursing home placement of patients with Alzheimer disease. A randomized controlled trial. JAMA 1996; 276: 1725–1731.PubMedCrossRefGoogle Scholar
  42. 42.
    Mohide EA, Pringle DM, Streiner DL, Gilbert JR, Muir G, Tew M. A randomized trial of family caregiver support in the home management of dementia. J Am Geriatr Soc 1990; 38: 446–454.PubMedGoogle Scholar
  43. 43.
    Lawton MP, Brody EM, Saperstein AR. A controlled study of respite service for caregivers of Alzheimer’s patients. Gerontologist 1989; 29: 8–16.PubMedCrossRefGoogle Scholar
  44. 44.
    Teri 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; 290: 2015–2022.PubMedCrossRefGoogle Scholar
  45. 45.
    Tariot PN, Farlow MR, Grossberg GT, Graham SM, McDonald S, Gergel I; Memantine Study Group. Memantine treatment in patients with moderate to severe Alzheimer disease already receiving donepezil: a randomized controlled trial. JAMA 2004; 291: 317–324.PubMedCrossRefGoogle Scholar
  46. 46.
    Birks J. Cholinesterase inhibitors for Alzheimer’s disease. Cochrane Database Syst Rev. 2006; 1: CD005593.PubMedGoogle Scholar
  47. 47.
    Haupt M, Kurz A, Janner M. A 2-year follow-up of behavioural and psychological symptoms in Alzheimer’s disease. Dement Geriatr Cogn Disord 2000; 11: 147–152.PubMedCrossRefGoogle Scholar
  48. 48.
    Teri L, Gibbons LE, McCurry SM et al. Exercise plus behavioral management in patients with Alzheimer disease: a randomized controlled trial. JAMA 2003; 290: 2015–2022.PubMedCrossRefGoogle Scholar
  49. 49.
    McCurry SM, Gibbons LE, Logsdon RG, Vitiello MV, Teri L. Nighttime insomnia treatment and education for Alzheimer’s disease: a randomized, controlled trial. J Am Geriatr Soc. 2005; 53: 793–802.PubMedCrossRefGoogle Scholar
  50. 50.
    Brodaty H, Green A, Koschera A. Meta-analysis of psychosocial interventions for caregivers of people with dementia J Am Geriatr Soc 2003; 51: 657–664.PubMedCrossRefGoogle Scholar
  51. 51.
    Mittelman MS, Haley WE, Clay OJ, Roth DL. Improving caregiver well-being delays nursing home placement of patients with Alzheimer disease. Neurology 2006; 67: 1592–1599.PubMedCrossRefGoogle Scholar
  52. 52.
    Geldmacher DS. Treatment guidelines for Alzheimer’s disease: redefining perceptions in primary care. Prim Care Companion J Clin Psychiatry 2007; 9: 113–121.PubMedGoogle Scholar
  53. 53.
    Aguero-Torres H, Fratiglioni L, Guo Z, Viitanen M, von Strauss E, Winblad B. Dementia is the major cause of functional dependence in the elderly: 3-year follow-up data from a population-based study. Am J Public Health. 1998; 88: 1452–1456.PubMedCrossRefGoogle Scholar
  54. 54.
    Zanetti O, Binetti G, Magni E, Rozzini L, Bianchetti A, Trabucchi M. Procedural memory stimulation in Alzheimer’s disease: impact of a training programme. Acta Neurol Scand 1997; 95: 152–157.PubMedCrossRefGoogle Scholar
  55. 55.
    Beck C, Heacock P, Mercer SO, Walls RC, Rapp CG, Vogelpohl TS. Improving dressing behavior in cognitively impaired nursing home residents. Nurs Res 1997; 46: 126–132.PubMedCrossRefGoogle Scholar
  56. 56.
    Coyne ML, Hoskins L. Improving eating behaviors in dementia using behavioural strategies. Clin Nurs Res 1997; 6: 275–290PubMedCrossRefGoogle Scholar
  57. 57.
    Tappen RM. The effect of skill training on functional abilities of nursing home residents with dementia. Res Nurs Health 1994; 17: 159–165PubMedCrossRefGoogle Scholar
  58. 58.
    Guerin O, Andrieu S, Schneider SM et al. Different modes of weight loss in Alzheimer disease: a prospective study of 395 patients. Am J Clin Nutr 2005; 82: 435–441.PubMedGoogle Scholar
  59. 59.
    Arkin SM. Student-led exercise sessions yield significant fitness gains for Alzheimer’s patients. Am J Alzheimers Dis Other Demen 2003; 18: 159–170.PubMedCrossRefGoogle Scholar
  60. 60.
    Thomas VS, Hageman PA. Can neuromuscular strength and function in people with dementia be rehabilitated using resistance-exercise training? Results from a preliminary intervention study. J Gerontol A Biol Sci Med Sci 2003; 58: 746–751.PubMedGoogle Scholar
  61. 61.
    Rolland Y, Rival L, Pillard F et al. Feasibily of regular physical exercise for patients with moderate to severe Alzheimer disease. J Nutr Health Aging 2000; 4: 109–113.PubMedGoogle Scholar
  62. 62.
    Rolland Y, Pillard F, Klapouszczak A et al. Exercise program for nursing home residents with Alzheimer’s disease: a 1-year randomized, controlled trial. J Am Geriatr Soc 2007; 55: 158–165.PubMedCrossRefGoogle Scholar
  63. 63.
    Heyn P, Abreu BC, Ottenbacher KJ. The effects of exercise training on elderly persons with cognitive impairment and dementia: a meta-analysis. Arch Phys Med Rehabil 2004; 85: 1694–1704.PubMedCrossRefGoogle Scholar

Copyright information

© Springer-Verlag France and Serdi Éditions 2008

Authors and Affiliations

  • F. Nourhashemi
    • 1
    • 2
  • S. Gillette-Guyonnet
    • 1
    • 2
  • S. Andrieu
    • 2
    • 3
  • Y. Rolland
    • 1
    • 2
  • P. -J. Ousset
    • 1
    • 2
  • B. Vellas
    • 1
    • 2
  • The PLASA Group
  1. 1.Service de Médecine Interne et Gérontologie CliniqueCHU Toulouse, Hôpital CasselarditToulouseFrance
  2. 2.Inserm U558ToulouseFrance
  3. 3.CHU ToulouseService d’épidémiologie et de santé publiqueToulouseFrance

Personalised recommendations