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Why did an effective Dutch complex psycho-social intervention for people with dementia not work in the German healthcare context? Lessons learnt from a process evaluation alongside a multicentre RCT.

Abstract

Background The positive effects of the Dutch Community Occupational Therapy in Dementia programme on patients' daily functioning were not found in a multicentre randomised controlled trial (RCT) in Germany. Objectives To evaluate possible effect modification on the primary outcome within the German RCT with regard to (1) participant characteristics, (2) treatment performance and (3) healthcare service utilisation; and (4) to compare the design and primary outcome between the German and the original Dutch study. Methods (1) The impact of participant baseline data on the primary outcome was analysed in exploratory ANCOVA and regression analyses. (2) Therapists completed questionnaires on context and performance problems. The main problems were identified by a qualitative content analysis and focus-group discussion. Associations of the primary outcome with scores of participant adherence and treatment performance were evaluated by regression analysis. (3) Utilisation rates of healthcare services were controlled for significant group differences. (4) Differences in the Dutch and German study design were identified, and the primary outcome was contrasted at the item level. Results (1) Participant characteristics could not explain more than 5% of outcome variance. (2) The treatment performance of some active intervention components was poor but not significantly associated with the primary outcome. (3) There were no significant group differences in the utilisation of healthcare resources. (4) In contrast to the Dutch waiting-control group, the active intervention in the German control group may have reduced group differences in the current RCT. The German patients demonstrated a higher independence at baseline and less improvement in instrumental activities of daily living. Conclusion The differences in outcome may be explained by a more active control treatment, partially poor experimental treatment and less room for improvement in the German sample. Future cross-national transfers should be prepared by pilot studies assessing the applicability of the intervention and patient needs specific to the target country. Trial registration International Clinical Trials Registry Platform, DRKS00000053.

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  • Authors+Show Affiliations

    ,

    Department of Occupational Therapy, Centre of Geriatric Medicine and Gerontology Freiburg, University Hospital Freiburg, Freiburg, Germany.

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    Source

    BMJ open 1:1 2011 Aug 09 pg e000094

    Pub Type(s)

    Journal Article

    Language

    eng

    PubMed ID

    22021759

    Citation

    Voigt-Radloff, Sebastian, et al. "Why Did an Effective Dutch Complex Psycho-social Intervention for People With Dementia Not Work in the German Healthcare Context? Lessons Learnt From a Process Evaluation Alongside a Multicentre RCT." BMJ Open, vol. 1, no. 1, 2011, pp. e000094.
    Voigt-Radloff S, Graff M, Leonhart R, et al. Why did an effective Dutch complex psycho-social intervention for people with dementia not work in the German healthcare context? Lessons learnt from a process evaluation alongside a multicentre RCT. BMJ Open. 2011;1(1):e000094.
    Voigt-Radloff, S., Graff, M., Leonhart, R., Hüll, M., Rikkert, M. O., & Vernooij-Dassen, M. (2011). Why did an effective Dutch complex psycho-social intervention for people with dementia not work in the German healthcare context? Lessons learnt from a process evaluation alongside a multicentre RCT. BMJ Open, 1(1), pp. e000094. doi:10.1136/bmjopen-2011-000094.
    Voigt-Radloff S, et al. Why Did an Effective Dutch Complex Psycho-social Intervention for People With Dementia Not Work in the German Healthcare Context? Lessons Learnt From a Process Evaluation Alongside a Multicentre RCT. BMJ Open. 2011 Aug 9;1(1):e000094. PubMed PMID: 22021759.
    * Article titles in AMA citation format should be in sentence-case
    TY - JOUR T1 - Why did an effective Dutch complex psycho-social intervention for people with dementia not work in the German healthcare context? Lessons learnt from a process evaluation alongside a multicentre RCT. AU - Voigt-Radloff,Sebastian, AU - Graff,Maud, AU - Leonhart,Rainer, AU - Hüll,Michael, AU - Rikkert,Marcel Olde, AU - Vernooij-Dassen,Myrra, Y1 - 2011/08/09/ PY - 2011/10/25/entrez PY - 2011/10/25/pubmed PY - 2011/10/25/medline SP - e000094 EP - e000094 JF - BMJ open JO - BMJ Open VL - 1 IS - 1 N2 - Background The positive effects of the Dutch Community Occupational Therapy in Dementia programme on patients' daily functioning were not found in a multicentre randomised controlled trial (RCT) in Germany. Objectives To evaluate possible effect modification on the primary outcome within the German RCT with regard to (1) participant characteristics, (2) treatment performance and (3) healthcare service utilisation; and (4) to compare the design and primary outcome between the German and the original Dutch study. Methods (1) The impact of participant baseline data on the primary outcome was analysed in exploratory ANCOVA and regression analyses. (2) Therapists completed questionnaires on context and performance problems. The main problems were identified by a qualitative content analysis and focus-group discussion. Associations of the primary outcome with scores of participant adherence and treatment performance were evaluated by regression analysis. (3) Utilisation rates of healthcare services were controlled for significant group differences. (4) Differences in the Dutch and German study design were identified, and the primary outcome was contrasted at the item level. Results (1) Participant characteristics could not explain more than 5% of outcome variance. (2) The treatment performance of some active intervention components was poor but not significantly associated with the primary outcome. (3) There were no significant group differences in the utilisation of healthcare resources. (4) In contrast to the Dutch waiting-control group, the active intervention in the German control group may have reduced group differences in the current RCT. The German patients demonstrated a higher independence at baseline and less improvement in instrumental activities of daily living. Conclusion The differences in outcome may be explained by a more active control treatment, partially poor experimental treatment and less room for improvement in the German sample. Future cross-national transfers should be prepared by pilot studies assessing the applicability of the intervention and patient needs specific to the target country. Trial registration International Clinical Trials Registry Platform, DRKS00000053. SN - 2044-6055 UR - https://www.unboundmedicine.com/medline/citation/22021759/Why_did_an_effective_Dutch_complex_psycho_social_intervention_for_people_with_dementia_not_work_in_the_German_healthcare_context_Lessons_learnt_from_a_process_evaluation_alongside_a_multicentre_RCT_ L2 - http://bmjopen.bmj.com/cgi/pmidlookup?view=long&pmid=22021759 DB - PRIME DP - Unbound Medicine ER -