Original StudyThe Effect of a Multicomponent Intervention on Quality of Life in Residents of Nursing Homes: A Randomized Controlled Trial (COSMOS)
Section snippets
Participants and Settings
COSMOS was a multicenter, cluster-randomized, single-blind controlled trial. We chose this design to control for contamination, because the implementation of the multicomponent intervention was based on an educational program for NH staff.16 The intervention lasted 4 months, with data collection at baseline and months 4 and 9. The researchers' networking and promotional work ensured NH recruitment located in 8 small and large, wealthy and less prosperous municipalities in western and southeast
Results
Between May 2014 and December 2015, a total of 723 patients from 33 NHs were cluster randomized to the intervention group (36 units; N = 394) or control (31 units; N = 329); 97 patients were excluded from the intervention group and 81 from control (Figure 1). A total of 461 (85%) participants completed the assessment at month 4, and 397 (73%) follow-up assessment at month 9. Dropout rates were similar in the intervention (83 [28%] participants) and control (65 [26%] participants) (P = .65);
Discussion
Our study showed that the COSMOS intervention did not improve QoL in NH patients during the active intervention from baseline to month 4. However, follow-up analyses between months 4 and 9 demonstrated significant effects on QoL in the intervention group compared to controls, as measured by EQ-VAS and QUALIDEM. Improvements were especially related to care relationship, positive affect, and social relations. The trial offered significant enhancements for some of the secondary outcomes (CGIC;
Conclusion and Implications
COSMOS provides a nonpharmacologic multicomponent intervention to manage multimorbid NH patients and to support health care staff who are incorporated in a standardized education program. Temporarily, the QoL decreased in the intervention group, leading to our hypothesis that staff may be overwhelmed by the work-intensive intervention period. However, the decrease reversed significantly during follow-up, indicating a potential learning effect. Further, the intervention group improved in ADL
Acknowledgments
We thank the patients, their relatives, and the NH staff for their willingness and motivation that made this work possible.
The COSMOS trial and EF, IA, CG, and DDS were supported by the Research Council of Norway (sponsor's protocol code 222113/H10); TH and TE were financed by the University of Bergen. BSH would like to thank the G.C. Rieber Foundation and the Norwegian government for supporting our work at the Centre for elderly and nursing home medicine, University of Bergen, Norway. The
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Declaration of Interest: BSH, EF, IA, CG, TH, TE, GS, IT, and DDS declare that they have no competing interests.
CB reports grants and personal fees from Lundbeck, grants and personal fees from Acadia, personal fees from Roche, personal fees from Orion, personal fees from GSK, personal fees from Otusaka, personal fees from Heptares, personal fees from Lilly, outside the submitted work. DA has received research support and/or honoraria from AstraZeneca, H. Lundbeck, Novartis Pharmaceuticals and GE Health, and serves as paid consultant for H. Lundbeck, Eisai, and Axovant.
Role of the funding source: The funding source had no role in study design, data collection, data analyses, data interpretation or writing of the report.