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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.
- RCT—Alzheimer's disease—complex intervention—process evaluation
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Footnotes
To cite: 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:e000094. doi:10.1136/bmjopen-2011-000094
Funding German Federal Ministry of Health, Reference Number: IIA5-2508FSB111/44-004.
Competing interests MOR: consultancy for Jansen-Cilag and Numico. MH: grants from Wyeth, Pfizer and Medivation; payment for lectures from Wyeth, Pfizer and Merz.
Ethics approval Ethics approval was provided by the Medical Ethics Committee of the University Hospital Freiburg (no 110/08).
Contributors SVR, MG, RL, MH and MVD contributed to the study conception and design. SVR conducted the data and study management, and prepared the statistical analysis. RL performed the statistical analysis. SVR drafted the manuscript. MG, RL, MH, MOR and MVD revised the manuscript critically for important intellectual content. All authors read and approved the final manuscript.
Provenance and peer review Not commissioned; externally peer reviewed.
Data sharing statement Data sets can be provided on request for fellow researchers in the context of collaborative projects and publications.