A multimodal individualized long-term intervention to prevent functional decline after stroke (LAST-long): a single blinded randomised controlled trial.

Background: Despite the lack of evidence, the Stroke Action Plan for Europe recommends coordinated support after initial rehabilitation. This trial investigated if a coordinator-led multimodal intervention was superior to standard care in preventing dependency and functional decline after stroke. Methods: In this single blinded randomised controlled multi-centre trial, patients were consecutively screened, included and randomised (1:1) by a web-based randomization system to an intervention or a control group at the out-patient clinics at four Norwegian hospitals three months post-stroke. Blinded assessments were performed at inclusion and at 6-, 12-, and 18-month follow-up. The inclusion criteria were; age ≥18 years, life expectancy ≥12 months (assessed by the physician), modified Rankin Scale (mRS) score <5, vulnerable to functional decline (defined by other measures). The control group received standard care, while the intervention group additionally received monthly follow-up by a community-based stroke coordinator who applied a study specific checklist to identify the patients' risk profile within multiple domains. Individual goals and action points were defined accordingly. The intervention lasted for 18 months. Mixed models were used to evaluate differences between the groups for the primary endpoint (mRS at 18-month follow-up) and secondary endpoints (activities of daily living, cognitive function, physical function, patient reported outcomes, physical activity, blood pressure, body mass index and blood tests) at 6-, 12-, and 18-month follow-up. The trial was registered at ClinicalTrials.gov identifier: NCT03859063. The trial has been completed. Findings: The LAST-long trial was conducted from April 11, 2019 to August 28, 2024. In total, 301 participants (48% women); mean age 71·3 (SD 12·3) years, National Institute of Health Stroke Scale admission score 3·38 (SD 4·21), and mRS at inclusion 1·6 (SD 0·9), were randomised to the intervention (n = 152) or control (n = 149) group 108.0 (SD 18·5) days post stroke. The number of serious adverse events (deaths, hospitalisation due to cardiovascular events, cerebrovascular events or fall with or without fracture) was 32 (21·1%) in the intervention group and 33 (22·1%) in the control group. At 18 months, the estimated difference between the groups was 0·03 (95% CI: -0·16 to 0·22), p = 0·79 for mRS. Interpretation: The 18-month multimodal intervention was not superior to standard care received by the control group in people with mild stroke. An even longer follow-up period might be needed to investigate the effect of the intervention on hard outcomes like death or recurrent vascular events. Funding: The Research Council of Norway, The Joint Research Committee between St. Olavs Hospital and the Faculty of Medicine and Health Sciences, NTNU (FFU), Foundation Dam.