Trial reportBMC psychiatry2026
Effects of a complex intervention on agitation and aggression in people living with dementia and mild cognitive impairment in shared-housing arrangements: results for a secondary outcome of the multicenter, cluster-randomized controlled DemWG study.
Trial report in BMC psychiatry, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
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10 authors.
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Abstract
backgroundAlthough some studies have suggested that homelike care environments can have beneficial effects on people living with dementia (PlwDs) and people living with mild cognitive impairment (PlwMCIs), studies on effects of a non-pharmacological, psychosocial intervention on behavioral and psychological symptoms of dementia (BPSDs) in the setting of shared-housing arrangements (SHAs) are still lacking.
methodsIn the prospective, multicenter, mixed-methods, cluster-randomized controlled DemWG study, 97 SHAs comprising 341 PlwDs or PlwMCIs were randomly assigned to either the intervention group (IG) or control group (CG). The complex intervention consisted of the education of nursing staff in SHAs (Component A), the education of general practitioners (Component B), and the multicomponent, psychosocial group intervention MAKS-mk+ (Component C). BPSDs (secondary outcome of the DemWG study) were assessed with the Cohen-Mansfield Agitation Inventory-Short Form (CMAI-SF) and the Neuropsychiatric Inventory-Nursing Home Version (NPI-NH) at baseline (t0), 6 months after baseline (t1) and 12 months after baseline (t2). Unadjusted and adjusted generalized estimating equations (GEE) models were computed to investigate possible effects of the complex intervention on the outcome variables at t1 or t2.
resultsIn the intention-to-treat (ITT) sample, the adjusted GEE models showed that participants in the IG had a significantly lower CMAI-SF score at t1 and at t2 than participants in the CG with a small- to medium-sized effect (RESI = 0.26 [t1] & RESI = 0.26 [t2]). Regarding the NPI-NH, the adjusted GEE models showed no significant differences between the IG and CG at t1 and t2. Sensitivity analyses on individuals' actual average weekly frequency of participating in the MAKS-mk + intervention ("as treated") showed results comparable to the ITT analysis. DISCUSSION: The results of the study show that the complex intervention had a positive effect on agitation and aggression in PlwDs or PlwMCIs with a small- to medium-sized effect. Overall, these findings should also contribute to improvement in the caregiving situation and living conditions of relatives and professional caregivers. As the intervention has demonstrated feasibility in the SHA setting, more consideration should be given to implementing it in everyday SHA care.
trial registrationISRCTN89825211 (Registered prospectively, July 16, 2019).
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