Life- and person-centred help in Mecklenburg-Western Pomerania, Germany (DelpHi): study protocol for a randomised controlled trial

详细信息    查看全文

• 作者：Jochen René Thyrian (1) (8)
  Thomas Fi? (1)
  Adina Dreier (2)
  Georgia B?wing (1)
  Aniela Angelow (1) (3)
  Sven Lueke (1) (4)
  Stefan Teipel (5) (6)
  Steffen Fle?a (4)
  Hans J?rgen Grabe (7)
  Harald Jürgen Freyberger (7)
  Wolfgang Hoffmann (1) (2)
  
• 关键词：Dementia care ; Population ; based ; Care management ; Intervention
• 刊名：Trials
• 出版年：2012
• 出版时间：December 2012
• 年：2012
• 卷：13
• 期：1
• 全文大小：299KB
• 参考文献：1. Fendrich K, Hoffmann W: More than just aging societies: the demographic change has an impact on actual numbers of patients. / J Public Health 2007, 15:345-51. CrossRef
  2. Hampel H, Prvulovic D, Teipel S, Jessen F, Luckhaus C, Fr?lich L, Riepe MW, Dodel R, Leyhe T, Bertram L, Hoffmann W: Faltraco F; German Task Force on Alzheimer’s Disease (GTF-AD): The future of Alzheimer’s disease: the next 10 years. / Prog Neurobiol 2011, 95:718-28. CrossRef
  3. Bickel H: / Deutsche Alzheimer Gesellschaft e.V.: Die Epidemiologie der Demenz. Vol. 1. Das Wichtigste-Informationsblatt der Deutschen Alzheimer Gesellschaft e.V, Berlin; 2008. [http://www.deutsche-alzheimer.de/fileadmin/alz/pdf/factsheets/FactSheet01.pdf]
  4. Institut für Qualit?t und Wirtschaftlichkeit im Gesundheitswesen (IQWiG): / Cholinesterasehemmer bei Alzheimer Demenz (Abschlussbericht A05-9A:). IQWiG, K?ln; 2007. [https://www.iqwig.de/download/A05-19A_Abschlussbericht_Cholinesterasehemmer_bei_Alzheimer_Demenz.pdf]
  5. Thyrian JR, Dreier A, Fendrich K, Lueke S, Hoffmann W: Demenzerkrankungen: Wirksame Konzepte gesucht. / Dtsch Arztebl 2011, 108:A1954-A1956.
  6. Thyrian JR, John U: Population impact: definition, calculation and its use in prevention science in the example of tobacco smoking reduction. / Health Policy 2007, 82:348-56. CrossRef
  7. Pentzek M, Fuchs A, Wiese B, Cvetanovska-Pllashniku G, Haller F, Maier W, Riedel-Heller SG, Angermeyer MC, Bickel H, M?sch E, Weyerer S, Werle J, van den Bussche H, Eisele M, Kaduszkiewicz H, AgeCoDe Study Group, AgeCoDe Study Group: General practitioners-judgment of their elderly patients-cognitive status. / J Gen Intern Med 2009, 24:1314-317. CrossRef
  8. Ashford JW, Borson S, O’Hara R, Dash P, Frank L, Robert P, Shankle WR, Tierney MC, Brodaty H, Schmitt FA, Kraemer HC, Buschke H, Fillit H: Should older adults be screened for dementia? It is important to screen for evidence of dementia! / Alzheimers Dement 2007, 3:75-0. CrossRef
  9. Ashford JW, Borson S: Primary care screening for dementia and mild cognitive impairment. / JAMA 2008, 299:1132-133. CrossRef
  10. Brayne C, Fox C, Boustani M: Dementia screening in primary care: is it time? / JAMA 2007, 298:2409-411. A published erratum appears in JAMA 2008, 299:634 CrossRef
  11. Rafii MS, Galasko D: Primary care screening for dementia and mild cognitive impairment. / JAMA 2008, 299:1132. CrossRef
  12. Marengoni A, Rizzuto D, Wang HX, Winblad B, Fratiglioni L: Patterns of chronic multimorbidity in the elderly population. / J Am Geriatr Soc 2009, 57:225-30. CrossRef
  13. Malone DC, McLaughlin TP, Wahl PM, Leibman C, Arrighi HM, Cziraky MJ, Mucha LM: Burden of Alzheimer’s disease and association with negative health outcomes. / Am J Manag Care 2009, 15:481-88.
  14. Dinkel RH, Lebok UH: The effects of dementia in German acute care hospitals. / Dement Geriatr Cogn Disord 1997, 8:314-19. CrossRef
  15. Luck T, Riedel-Heller SG, Kaduszkiewicz H, Bickel H, Jessen F, Pentzek M, Wiese B, Koelsch H, van den Bussche H, Abholz HH, Moesch E, Gorfer S, Angermeyer MC, Maier W, Weyerer S, AgeCoDe Group, AgeCoDe Group: Mild cognitive impairment in general practice: age-specific prevalence and correlate results from the German study on ageing, cognition and dementia in primary care patients (AgeCoDe). / Dement Geriatr Cogn Disord 2007, 24:307-16. CrossRef
  16. Ihl R: Integrative Demenzbehandlung [abstract 94]. / Neurogeriatrie 2011, 8:S15-S16.
  17. Engels D, Pfeuffer F, Heinemann Knoch M, Knoch T, Korte E, K?hler L, Sch?ufele M, Schneekloth U, Schr?der JW, Teufel S, Wahl HW, Weyerer S: M?glichkeiten und Grenzen selbstst?ndiger Lebensführung in privaten Haushalten (MuG III). In / Report 2-50. München: Federal Ministry for Family Affairs, Senior Citizens, Women and Youth Edited by: Schneekloth U, Wahl HW. 2005. [http://www.bmfsfj.de/doku/Publikationen/mug/01-Redaktion/PDF-Anlagen/gesamtdokument,property=pdf,bereich=mug,sprache=de,rwb=true.pdf]
  18. Schneekloth U, Wahl HW (Eds): / Selbst?ndigkeit und Hilfebedarf bei ?lteren Menschen in Privathaushalten: Pflegearrangements, Demenz, Versorgungsangebote. 2nd edition. W Kohlhammer GmbH, Stuttgart; 2008.
  19. Etters L, Goodall D, Harrison BE: Caregiver burden among dementia patient caregivers: a review of the literature. / J Am Acad Nurse Pract 2008, 20:423-28. CrossRef
  20. Thompson CA, Spilsbury K, Hall J, Birks Y, Barnes C, Adamson J: Systematic review of information and support interventions for caregivers of people with dementia. / BMC Geriatr 2007, 7:18. CrossRef
  21. Dietl M, Kornhuber J, Sch?ffski O, Gr??el E: Cost-effectiveness model of a community-based service for dementia caregivers] [in German. / Gesundheitswesen 2010, 72:99-05. CrossRef
  22. Donath C, Luttenberger K, Gr??el E: Dementia caregiver skill training: predictors for utilisation and expected quality from the family caregiver’s point of view [in German]. / Gesundheitswesen 2009, 71:291-92. CrossRef
  23. Boustani M, Callahan CM, Unverzagt FW, Austrom MG, Perkins AJ, Fultz BA, Hui SL, Hendrie HC: Implementing a screening and diagnosis program for dementia in primary care. / J Gen Intern Med 2005, 20:572-77. CrossRef
  24. Boustani M, Peterson B, Hanson L, Harris R, Lohr KN, U.S. Preventive Services Task Force, U.S. Preventive Services Task Force: Screening for dementia in primary care: a summary of the evidence for the U.S. Preventive Services Task Force. / Ann Intern Med 2003, 138:927-37.
  25. 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, 295:2148-157. CrossRef
  26. Gr??el E, Trilling A, Donath C, Luttenberger K: Support groups for dementia caregivers: predictors for utilisation and expected quality from a family caregiver’s point of view. A questionnaire survey part I*. / BMC Health Serv Res 2010, 10:219. CrossRef
  27. Donath C, Gra?el E, Grossfeld-Schmitz M, Menn P, Lauterberg J, Wunder S, Marx P, Ruckd?schel S, Mehlig H, Holle R: Effects of general practitioner training and family support services on the care of home-dwelling dementia patients: results of a controlled cluster-randomized study. / BMC Health Serv Res 2010, 10:314. CrossRef
  28. Dreier A, Thyrian JR, Hoffmann W: Dementia care manager in der ambulanten Demenzversorgung: Entwicklung einer innovativen Qualifizierung für Pflegefachkr?fte. / Pflege und Gesellschaft 2011, 16:53-4.
  29. Kalbe E, Kessler J, Calabrese P, Smith R, Passmore AP, Brand M, Bullock R: DemTect: a new, sensitive cognitive screening test to support the diagnosis of mild cognitive impairment and early dementia. / Int J Geriatr Psychiatry 2004, 19:136-43. CrossRef
  30. Kalbe E, Brand M, Kessler J, Calabrese P: Der DemTect in der klinischen Anwendung. / Z Gerontol Psychiatrie 2005, 18:121-30. CrossRef
  31. Cohen J: / Statistical Power Analysis for the Behavioral Sciences. 2nd edition. Lawrence Erlbaum Associates, Hillsdale, NJ; 1988.
  32. Cummings JL, Mega M, Gray K, Rosenberg-Thompson S, Carusi DA, Gornbein J: The Neuropsychiatric Inventory: comprehensive assessment of psychopathology in dementia. / Neurology 1994, 44:2308-314. CrossRef
  33. Zaudig M, Mittelhammer J, Hiller W, Pauls A, Thora C, Morinigo A, Mombour W: SIDAM: a structured interview for the diagnosis of dementia of the Alzheimer type, multi-infarct dementia and dementias of other aetiology according to ICD-10 and DSM-III-R. / Psychol Med 1991, 21:225-36. CrossRef
  34. Kang M, Ragan BG, Park JH: Issues in outcomes research: an overview of randomization techniques for clinical trials. / J Athl Train 2008, 43:215-21. CrossRef
  35. Schulz KF, Grimes DA: Allocation concealment in randomised trials: defending against deciphering. / Lancet 2002, 359:614-18. CrossRef
  36. Logsdon RG, Gibbons LE, McCurry SM, Teri L: Assessing quality of life in older adults with cognitive impairment. / Psychosom Med 2002, 64:510-19.
  37. Schaie KW: The database. In / Developmental Influences on Adult Intelligence: The Seattle Longitudinal Study. Oxford University Press, Oxford; 2005:38-1. CrossRef
  38. Zank S, Schacke C, Leipold B: Berliner Inventar zur Angeh?rigenbelastung: Demenz (BIZA-D). / Z Klin Psychol Psychother 2006, 35:296-05.42. Deutsche Gesellschaft für Psychiatrie PuND, Deutsche Gesellschaft für Neurologie (DGN): Zusammenarbeit mit der Deutschen Alzheimer Gesellschaft e.V.: Selbsthilfe Demenz (S-3 Leitlinie “Demenzen-. Bonn: Herausgebende Fachgesellschaften; 2009. [http://www.dgppn.de/fileadmin/user_upload/_medien/download/pdf/kurzversion-leitlinien/s3-leitlinie-demenz-lf.pdf] CrossRef
  39. / Deutsche Gesellschaft für Allgemeinmedizin und Familienmedizin e.V. (DEGAM): DEGAM-Leitlinie Nr 12: Demenz. Omikron, Düsseldorf; 2008.
  40. Holt S, Schmiedl S, Thürmann PA: Potentially inappropriate medications in the elderly: the PRISCUS list] [in German. / Dtsch Arztebl Int 2010, 107:543-51.
  41. Campbell N, Boustani M, Limbil T, Ott C, Fox C, Maidment I, Schubert CC, Munger S, Fick D, Miller D, Gulati R: The cognitive impact of anticholinergics: a clinical review. / Clin Interv Aging 2009, 4:225-33.
  42. Erzigkeit H, Lehfeld H, Pe?a-Casanova J, Bieber F, Yekrangi-Hartmann C, Rupp M, Rappard F, Arnold K, Hindmarch I: The Bayer-Activities of Daily Living Scale (B-ADL): results from a validation study in three European countries. / Dement Geriatr Cogn Disord 2001, 12:348-58. CrossRef
  43. Hindmarch I, Lehfeld H, de Jongh P, Erzigkeit H: The Bayer Activities of Daily Living Scale (B-ADL). / Dement Geriatr Cogn Disord 1998,9(Suppl 2):20-6. CrossRef
  44. Fydrich T, Sommer G, Br?hler E: / F-SozU. Fragebogen zur sozialen Unterstützung: F-SozU. Hogrefe, G?ttingen; 2007. [http://www.franke-stendal.de/WS0708/Master/SPSS/GHF-et-al-F-SozU-Skript.pdf]
  45. Bullinger M, Kirchberger I: / SF-36 Fragebogen zum Gesundheitszustand. Hogrefe, Handanweisung. G?ttingen; 1998.
  46. Sandholzer H, Hellenbrand W, Renteln-Kruse W, van Weel C, Walker P: STEP: standardized assessment of elderly people in primary care [in German]. / Dtsch Med Wochenschr 2004,129(Suppl 4):S183-S226. CrossRef
  47. Derogatis LR, Melisaratos N: The brief symptom inventory: an introductory report. / Psychol Med 1983, 13:595-05. CrossRef
  48. Spitzer RL, Kroenke K, Williams JB: Validation and utility of a self-report version of PRIME-MD: the PHQ primary care study: Primary Care Evaluation Of Mental Disorders. Patient Health Questionnaire. / JAMA 1999, 282:1737-744. CrossRef
  49. L?we B, Zipfel S, Herzog W: / PHQ-D Gesundheitsfragebogen für Patienten. Pfizer, New York; 2002.
  50. Wimo A, Ijjungren G, Winblad B: Costs of dementia and dementia care: a review. / Int J Geriatr Psychiatry 1997, 12:841-56. CrossRef
  51. Fi? T, Ritter CA, Alte D, van den Berg N, Hoffmann W: Detection of drug related problems in an interdisciplinary health care model for rural areas in Germany. / Pharm World Sci 2010, 32:566-74. CrossRef
  52. Hoffmann W, van den Berg N, Thyrian JR, Fi? T: Frequency and determinants of potential drug-drug interactions in an elderly population receiving regular home visits by GPs -results of the home medication review in the AGnES-studies. / Pharmacoepidemiol Drug Saf 2011,20(12):1311-. CrossRef
  
• 作者单位：Jochen René Thyrian (1) (8)
  Thomas Fi? (1)
  Adina Dreier (2)
  Georgia B?wing (1)
  Aniela Angelow (1) (3)
  Sven Lueke (1) (4)
  Stefan Teipel (5) (6)
  Steffen Fle?a (4)
  Hans J?rgen Grabe (7)
  Harald Jürgen Freyberger (7)
  Wolfgang Hoffmann (1) (2)
  
  1. German Center for Neurodegenerative Diseases (DZNE) Greifswald, Ellernholzstrasse 1-2, Greifswald, D-17487, Germany
  8. German Center for Neurodegenerative Diseases (DZNE) Rostock/Greifswald, Ellernholzstrasse 1-2, D-Greifswald, 17487, Germany
  2. Department Epidemiology of Health Care and Community Health, Institute for Community Medicine, Ernst-Moritz-Arndt-University, Ellernholzstrasse 1-2, Greifswald, D-17487, Germany
  3. Department of Family Medicine, Institute for Community Medicine, Ellernholzstrasse 1-2, Greifswald, D-17487, Germany
  4. Institute for Business Administration and Health Care Management, Ernst-Moritz-Arndt-University, Friedrich-Loeffler-Strasse 70, Greifswald, D-17489, Germany
  5. Department of Psychiatry and Psychotherapy, University of Rostock, Gehlsheimer Strasse 20, Rostock, D-18471, Germany
  6. German Center for Neurodegenerative Diseases (DZNE) Rostock, Gehlsheimer Strasse 20, Rostock, D-18471, Germany
  7. Department of Psychiatry and Psychotherapy, University of Greifswald, Ellernholzstrasse 1-2, D-17489, Greifswald, Germany
  

文摘

Background The provision of appropriate medical and nursing care for people with dementia is a major challenge for the healthcare system in Germany. New models of healthcare provision need to be developed, tested and implemented on the population level. Trials in which collaborative care for dementia in the primary care setting were studied have demonstrated its effectiveness. These studies have been conducted in different healthcare systems, however, so it is unclear whether these results extend to the specific context of the German healthcare system. The objective of this population-based intervention trial in the primary care setting is to test the efficacy and efficiency of implementing a subsidiary support system on a population level for persons with dementia who live at home. Methods and study design The study was designed to assemble a general physician-based epidemiological cohort of people above the age of 70 who live at home (DelpHi cohort). These people are screened for eligibility to participate in a trial of dementia care management (DelpHi trial). The trial is a cluster-randomised, controlled intervention trial with two arms (intervention and control) designed to test the efficacy and efficiency of implementing a subsidiary support system for persons with dementia who live at home. This subsidiary support system is initiated and coordinated by a dementia care manager: a nurse with dementia-specific qualifications who delivers the intervention according to a systematic, detailed protocol. The primary outcome is quality of life and healthcare for patients with dementia and their caregivers. This is a multidimensional outcome with a focus on four dimensions: (1) quality of life, (2) caregiver burden, (3) behavioural and psychological symptoms of dementia and (4) pharmacotherapy with an antidementia drug and prevention or suspension of potentially inappropriate medication. Secondary outcomes include the assessment of dementia syndromes, activities of daily living, social support health status, utilisation of health care resources and medication. Discussion The results will provide evidence for specific needs in ambulatory care for persons with dementia and will show effective ways to meet those needs. Qualification requirements will be evaluated, and the results will help to modify existing guidelines and treatment paths. Trial registration NCT01401582