WHEDA study: effectiveness of occupational therapy at home for older people with dementia and their caregivers--the design of a pragmatic randomised controlled trial evaluating a Dutch programme in seven German centres

Sebastian Voigt-Radloff, Maud Graff, Rainer Leonhart, Katrin Schornstein, Myrra Vernooij-Dassen, Marcel Olde-Rikkert, Michael Huell, Sebastian Voigt-Radloff, Maud Graff, Rainer Leonhart, Katrin Schornstein, Myrra Vernooij-Dassen, Marcel Olde-Rikkert, Michael Huell

Abstract

Background: A recent Dutch mono-centre randomised controlled trial has shown that occupational therapy improves daily functioning in dementia. The aim of this present study is to compare the effects of the Dutch community occupational therapy programme with a community occupational therapy consultation on daily functioning in older people with mild or moderate dementia and their primary caregivers in a German multi-centre context.

Methods/design: A multi-centre single blind randomised controlled trial design is being used in seven health care centres (neurological, psychiatric and for older people) in urban regions. Patients are 1:1 randomised to treatment or control group. Assessors are blind to group assignment and perform measurements on both groups at baseline, directly after intervention at 6 weeks and at 16, 26 and 52 weeks follow-up. A sample of 140 community dwelling older people (aged >65 years) with mild or moderate dementia and their primary caregivers is planned. The experimental intervention consists of an evidence-based community occupational therapy programme including 10 sessions occupational therapy at home. The control intervention consists of one community occupational therapy consultation based on information material of the Alzheimer Society. Providers of both interventions are occupational therapists experienced in treatment of cognitively impaired older people and trained in both programmes. 'Community' indicates that occupational therapy intervention occurs in the person's own home. The primary outcome is patients' daily functioning assessed with the performance scale of the Interview for Deterioration in Daily Living Activities in Dementia and video tapes of daily activities rated by external raters blind to group assignment using the Perceive, Recall, Plan and Perform System of Task Analysis. Secondary outcomes are patients' and caregivers' quality of life, mood and satisfaction with treatment; the caregiver's sense of competence, caregiver's diary (medication, resource utilisation, time of informal care); and the incidence of long-term institutionalisation. Process evaluation is performed by questionnaires and focus group discussion.

Discussion: The transfer from the Dutch mono-centre design to the pragmatic multi-site trial in a German context implicates several changes in design issues including differences in recruitment time, training of interventionists and active control group treatment.The study is registered under DRKS00000053 at the German register of clinical trials, which is connected to the International Clinical Trials Registry Platform.

Figures

Figure 1
Figure 1
WHEDA flow chart (planned progress).

References

    1. Blennow K, de Leon MJ, Zetterberg H. Alzheimer's disease. Lancet. 2006;368:387–403. doi: 10.1016/S0140-6736(06)69113-7.
    1. Ott A, Breteler MM, van Harskamp F, Stijnen T, Hofman A. Incidence and risk of dementia. The Rotterdam Study. Am J Epidemiol. 1998;147:574–80.
    1. Wancata J, Musalek M, Alexandrowicz R, Krautgartner M. Number of dementia sufferers in Europe between the years 2000 and 2050. Eur Psychiatry. 2003;18:306–313. doi: 10.1016/j.eurpsy.2003.03.003.
    1. Lobo A, Launer LJ, Fratiglioni L, Andersen K, Di Carlo A, Breteler MM, Copeland JR, Dartigues JF, Jagger C, Martinez-Lage J, Soininen H, Hofman A. Prevalence of dementia and major subtypes in Europe: A collaborative study of population-based cohorts. Neurology. 2000;54:4–9.
    1. Hofman A, Rocca WA, Brayne C, Breteler MM, Clarke M, Cooper B, Copeland JR, Dartigues JF, da Silva Droux A, Hagnell O. The prevalence of dementia in Europe: a collaborative study of 1980-1990 findings. Eurodem Prevalence Research Group. Int J Epidemiol. 1991;20:736–748. doi: 10.1093/ije/20.3.736.
    1. Fratiglioni L, Launer LJ, Andersen K, Breteler MM, Copeland JR, Dartigues JF, Lobo A, Martinez-Lage J, Soininen H, Hofman A. Incidence of dementia and major subtypes in Europe: A collaborative study of population-based cohorts. Neurologic Diseases in the Elderly Research Group. Neurology. 2000;54:S10–5.
    1. Jorm AF, Jolley D. The incidence of dementia. A meta-analysis. Neurology. 1998;51:728–733.
    1. Bickel H. Epidemiologie und Gesundheitsökonomie. In: Wallesch CW, Förstl H, editor. Demenzen Referenzreihe Neurologie. Stuttgart: Thieme Verlag; 2005. pp. 1–15.
    1. Robert Koch-Institut . Gesundheitsberichterstattung des Bundes, Heft 28 Altersdemenz. Robert Koch-Institut. Berlin; 2005.
    1. Wimo A, Jonsson L, Winblad B. An estimate of the worldwide prevalence and direct costs of dementia in 2003. Dement Geriatr Cogn Disord. 2006;21:175–81. doi: 10.1159/000090733.
    1. Statistisches Bundesamt . Gesundheit Krankheitskosten 2002. Statistisches Bundesamt. Wiesbaden; 2004.
    1. Hallauer JF, Schons M, Smala A, Berger K. Untersuchung von Krankheitskosten bei Patienten mit Alzheimer-Erkrankung. Gesundheitsökonomie und Qualitätsmanagement. 2000;5:73–79.
    1. Ernst RL, Hay JW, Fenn C, Tinklenberg J, Yesavage JA. Cognitive function and the costs of Alzheimer disease. An exploratory study. Arch Neurol. 1997;54:687–93.
    1. Hux MJ, O'Brien BJ, Iskedjian M, Goeree R, Gagnon M, Gauthier S. Relation between severity of Alzheimer's disease and costs of caring. CMAJ. 1998;159:457–65.
    1. World Health Organization . ICD-10: International statistical classification of diseases and related heath problems. World Health Organization. Geneva; 1992.
    1. American Psychiatric Association . Diagnostic and Statistical Manual of Mental Disorders 4th Ed (DSM-IV) American Psychiatric Association. Washington DC; 1994.
    1. Muò R, Schindler A, Vernero I, Schindler O, Ferrario E, Frisoni GB. Alzheimer's disease-associated disability: an ICF approach. Disabil Rehabil. 2005;27:1405–13. doi: 10.1080/09638280500052542.
    1. World Health Organization . International Classification of Functioning, Disability and Health (ICF) World Health Organization. Geneva; 2001.
    1. Giovannetti T, Bettcher BM, Libon DJ, Brennan L, Sestito N, Kessler RK. Environmental adaptations improve everyday action performance in Alzheimer's disease: empirical support from performance-based assessment. Neuropsychology. 2007;21:448–57. doi: 10.1037/0894-4105.21.4.448.
    1. Gitlin LN, Hauck WW, Dennis MP, Winter L. Maintenance of effects of the home environmental skill-building program for family caregivers and individuals with Alzheimer's disease and related disorders. J Gerontol A Biol Sci Med Sci. 2005;60:368–74.
    1. Mittelman MS, Haley WE, Clay OJ, Roth DL. Improving caregiver well-being delays nursing home placement of patients with Alzheimer disease. Neurology. 2006;67:1592–9. doi: 10.1212/01.wnl.0000242727.81172.91.
    1. Spijker A, Vernooij-Dassen M, Vasse E, Adang E, Wollersheim H, Grol R, Verhey F. Effectiveness of nonpharmacological interventions in delaying the institutionalization of patients with dementia: a meta-analysis. J Am Geriatr Soc. 2008;56:1116–28. doi: 10.1111/j.1532-5415.2008.01705.x.
    1. Gitlin LN, Winter L, Burke J, Chernett N, Dennis MP, Hauck WW. Tailored activities to manage neuropsychiatric behaviors in persons with dementia and reduce caregiver burden: a randomized pilot study. Am J Geriatr Psychiatry. 2008;16:229–39.
    1. Graff MJL, Melick van MBM. The development, testing and implementation of an occupational therapy guideline. The guideline for the OT diagnosis and treatment of older persons with cognitive impairments. Ned Tijdschr Ergother. 2000;28:169–74. In Dutch.
    1. Graff MJL, Vernooij-Dassen MJFJ, Hoefnagels WHL, Dekker J, Witte de LP. Occupational therapy at home for older individuals with mild to moderate cognitive impairments and their primary caregivers: a pilot study. Occup Ther J Res. 2003;23:155–63.
    1. Graff MJ, Vernooij-Dassen MJ, Thijssen M, Dekker J, Hoefnagels WH, Rikkert MG. Community based occupational therapy for patients with dementia and their care givers: randomised controlled trial. BMJ. 2006;333:1196. doi: 10.1136/.
    1. Graff MJ, Vernooij-Dassen MJ, Thijssen M, Dekker J, Hoefnagels WH, Olderikkert MG. Effects of community occupational therapy on quality of life, mood, and health status in dementia patients and their caregivers: a randomized controlled trial. J Gerontol A Biol Sci Med Sci. 2007;62:1002–9.
    1. Graff MJ, Adang EM, Vernooij-Dassen MJ, Dekker J, Jönsson L, Thijssen M, Hoefnagels WH, Rikkert MG. Community occupational therapy for older patients with dementia and their care givers: cost effectiveness study. BMJ. 2008;336:134–8. doi: 10.1136/.
    1. Boutron I, Moher D, Altman DG, Schulz KF, Ravaud P, for the CONSORT Group Methods and Processes of the CONSORT Group: Example of an Extension for Trials Assessing Nonpharmacologic Treatments. Ann Intern Med. 2008;148:W-60–W-66.
    1. Boutron I, Moher D, Altman DG, Schulz KF, Ravaud P, for the CONSORT Group Extending the CONSORT Statement to Randomized Trials of Nonpharmacologic Treatment: Explanation and Elaboration. Ann Intern Med. 2008;148:295–309.
    1. Zwarenstein M, Treweek S, Gagnier JJ, Altman DG, Tunis S, Haynes B, Oxman AD, Moher D, for the CONSORT and Pragmatic Trials in Healthcare (Practihc) groups Improving the reporting of pragmatic trials: an extension of the CONSORT statement. BMJ. 2008;337:a2390. doi: 10.1136/bmj.a2390.
    1. 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;12:189–98. doi: 10.1016/0022-3956(75)90026-6.
    1. Medizinscher Dienst der Spitzenverbände der Krankenkassen e.V Richtlinien der Spitzenverbände der Pflegekassen zur Begutachtung von Pflegebedürftigkeit nach dem XI Buch des Sozialgesetzbuches Version von. 2006.
    1. Kielhofner G, Mallinson T, Crawford C, Nowak M, Rigby M, Henry A, Walens D. Occupational performance history interview II German Version 21: Interview zur Betätigungsgeschichte. Idstein: Schulz-Kirchner; 2008.
    1. Hasselkus BR. Ethnographic interviewing: a tool for practice with family caregivers for the elderly. Occup Ther Pract. 1990;2:9–16. doi: 10.1177/1471301206069918.
    1. Graff MJL, Vernooij-Dassen MJ, Zajec J, Olde Rikkert MGM, Hoefnagels WHL, Dekker J. How can occupational therapy improve the daily performance and communication of an older patient with dementia and his primary caregiver? A case study. Dementia. 2006;5:503–32. doi: 10.1017/S1041610297004845.
    1. Deutsche Alzheimer Gesellschaft e. V . Leben mit Demenzkranken. Deutsche Alzheimer Gesellschaft e. V. Berlin; 2003.
    1. Deutsche Alzheimer Gesellschaft e. V . Ratgeber Häusliche Versorgung Demenzkranker. Deutsche Alzheimer Gesellschaft e. V. Berlin; 2006.
    1. Teunisse S, Derix MM. The interview for deterioration in daily living activities in dementia: agreement between primary and secondary caregivers. Int Psychogeriatr. 1997;9:155–62. doi: 10.1017/S1041610298005377.
    1. Böhm P, Peña-Casanova J, Aguilar M, Hernández G, Sol JM, Blesa R. Clinical validity and utility of the interview for deterioration of daily living in dementia for Spanish-speaking communities NORMACODEM Group. Int Psychogeriatr. 1998;10:261–70. doi: 10.1111/j.1440-1630.2007.00725.x.
    1. Chapparo C, Ranka J. Research Edition. Sydney: OP Network; 2006. The PRPP System of Task Analysis: User's Training Manual.
    1. Aubin G, Chapparo C, Gélinas I, Stip E, Rainville C. Use of the Perceive, Recall, Plan and Perform System of Task Analysis for persons with schizophrenia: A preliminary study. Australian Occupational Therapy Journal. 2009;56:189–99. doi: 10.1097/00005053-199402000-00005.
    1. Cyr M, Toupin J, Lesage A, Valiquette M. Assessment of independent living skills for psychotic patients: Further validity and reliability. Journal of Nervous and Mental Disease. 1994;182:91–97.
    1. Nott M, Chapparo C, Heard R. Reliability of the Perceive, Recall, Plan and Perform System of Task Analysis: a criterion referenced assessment. Australian Occupational Therapy Journal. 2008 doi: 10.1080/02699050802227170.
    1. Nott MT, Chapparo C, Heard R. Effective occupational therapy intervention with adults demonstrating agitation during post-traumatic amnesia. Brain Inj. 2008;22:669–83.
    1. Brod M, Stewart AL, Sands L, Walton P. Conceptualization and measurement of quality of life in dementia: The dementia quality of life instrument (DQoL) The Gerontologist. 1999;39:25–35.
    1. Suzuki M, Uchida A, Kanamori M, Ooshiro H. Development of the Dementia Quality of Life Instrument - Japanese version. Nippon Ronen Igakkai Zasshi. 2005;42:423–31.
    1. Suzuki M, Kanamori M, Greiner C, Ito K, Ooshiro H. Follow-up study on subjective quality of life for elderly persons with dementia using the Japanese version of Dementia Quality of Life Instrument (JDQoL) Nippon Ronen Igakkai Zasshi. 2006;43:485–91. doi: 10.1002/gps.1271.
    1. Selwood A, Thorgrimsen L, Orrell M. Quality of life in dementia - a one-year follow-up study. Int J Geriatr Psychiatry. 2005;20:232–237.
    1. Ready RE, Ott BR, Grace J. Factor structure of patient and caregiver ratings on the dementia quality of life instrument. Neuropsychol Dev Cogn B Aging Neuropsychol Cogn. 2007;14:144–54.
    1. Bullinger M, Kirchberger I. SF-36 Fragebogen zum Gesundheitszustand - Handanweisung (SF-36 and SF-12 Test Manual) Göttingen: Hogrefe Verlag; 1998.
    1. Ellert U, Bellach BM. The SF-36 in the Federal Health Survey - description of a current normal sample. Gesundheitswesen. 1999;61:184–90. doi: 10.1002/gps.1946.
    1. Arlt S, Hornung J, Eichenlaub M, Jahn H, Bullinger M, Petersen C. The patient with dementia, the caregiver and the doctor: cognition, depression and quality of life from three perspectives. Int J Geriatr Psychiatry. 2008;23:604–10.
    1. Bruce DG, Paley GA, Nichols P, Roberts D, Underwood PJ, Schaper F. Physical disability contributes to caregiver stress in dementia caregivers. J Gerontol A Biol Sci Med Sci. 2005;60:345–9. doi: 10.1016/0277-9536(95)00332-0.
    1. Vernooij-Dassen MJM, Persoon JM, Felling AJ. Predictors of sense of competence in caregivers of demented individuals. Soc Sci Med. 1996;43:41–9.
    1. Scholte op Reimer WJ, de Haan RJ, Pijnenborg JM, Limburg M, Bos GA van den. Assessment of burden in partners of stroke patients with the sense of competence questionnaire. Stroke. 1998;29:373–379. doi: 10.1186/1745-0179-3-11.
    1. Jansen A, van Hout H, van Marwijk H, Nijpel G, Gundy C, Vernooij-Dassen M, deVet H, Schellevi F, Stalman W. Sense of competence questionnaire among informal caregivers of older adults with dementia symptoms: A psychometric evaluation. Clinical Practice and Epidemiology in Mental Health. 2007;3:11. doi: 10.1177/014662167700100306.
    1. Radloff LS. The CES-D scale: a self-reported depression scale for research in the general population. Appl Psychol Measurement. 1977;1:385–401. doi: 10.1186/1471-2318-8-2.
    1. Joling KJ, van Hout HP, Scheltens P, Vernooij-Dassen M, Berg B van den, Bosmans J, Gillissen F, Mittelman M, van Marwijk HW. Cost-effectiveness of family meetings on indicated prevention of anxiety and depressive symptoms and disorders of primary family caregivers of patients with dementia: design of a randomized controlled trial. BMC Geriatr. 2008;8:2. doi: 10.1111/j.1532-5415.2007.01558.x.
    1. Taylor DH, Jr, Ezell M, Kuchibhatla M, Østbye T, Clipp EC. Identifying trajectories of depressive symptoms for women caring for their husbands with dementia. J Am Geriatr Soc. 2008;56:322–7. doi: 10.1017/S1041610207006278.
    1. Adams KB. Specific effects of caring for a spouse with dementia: differences in depressive symptoms between caregiver and non-caregiver spouses. Int Psychogeriatr. 2008;20:508–20. doi: 10.1002/gps.538.
    1. Gallicchio L, Siddiqi N, Langenberg P, Baumgarten M. Gender differences in burden and depression among informal caregivers of demented elders in the community. Int J Geriatr Psychiatry. 2002;17:154–63. doi: 10.1016/0006-3223(88)90038-8.
    1. Hautzinger M, Bailer M. Allgemeine Depressions Skala (ADS Test Manual) Göttingen: Beltz Test GmbH; 1992.
    1. Alexopoulos GS, Abrams RC, Young RC, Shamoian CA. Cornell Scale for Depression in Dementia. Biological Psychiatry. 1988;23:271–84. doi: 10.1016/j.acn.2004.03.010.
    1. Müller-Thomsen T, Arlt S, Mann U, Mass R, Ganzer S. Detecting depression in Alzheimer's disease: evaluation of four different scales. Arch Clin Neuropsychol. 2005;20:271–6.
    1. Kørner A, Lauritzen L, Abelskov K, Gulmann NC, Brodersen AM, Wedervang-Jensen T, Marie Kjeldgaard K. Rating scales for depression in the elderly: external and internal validity. J Clin Psychiatry. 2007;68:384–9. doi: 10.1002/gps.1098.
    1. Lam CK, Lim PP, Low BL, Ng LL, Chiam PC, Sahadevan S. Depression in dementia: a comparative and validation study of four brief scales in the elderly Chinese. Int J Geriatr Psychiatry. 2004;19:422–8. doi: 10.1002/gps.2103.
    1. Neubauer S, Holle R, Menn P, Grässel E. A valid instrument for measuring informal care time for people with dementia. Int J Geriatr Psychiatry. 2009;24:275–82. doi: 10.1017/S1041610208007564.
    1. Neubauer S, Holle R, Menn P, Grossfeld-Schmitz M, Graesel E. Measurement of informal care time in a study of patients with dementia. Int Psychogeriatr. 2008;20:1160–76. doi: 10.1016/j.archger.2006.03.001.
    1. Wimo A, Nordberg G. Validity and reliability of assessments of time. Comparisons of direct observations and estimates of time by the use of the resource utilization in dementia (RUD)-instrument. Arch Gerontol Geriatr. 2007;44:71–81. doi: 10.1016/0022-3956(82)90033-4.
    1. Yesavage JA, Brink TL, Rose TL, Lum O, Huang V, Adey M, Leirer VO. Development and validation of a geriatric depression screening scale: a preliminary report. J Psychiatr Res. 1983;17:1982–37.
    1. Cohen J. Statistical Power Analysis for the Behavioral Sciences. 2. Hillsdale, New Jersey: Lawrence Erlbaum Associates; 1988.
    1. Allison P. Missing data. Thousand Oaks: Sage; 2002.

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