Integrated care pathway in individuals with Long COVID: STIMULATE-ICP, a cluster-randomized, phase 3 trial

A cluster-randomized, phase 3 trial was conducted in Long COVID (LC) patients, evaluating the effectiveness of integrated care pathways (ICPs). Conducted in six National Health Service clinics across England, the study recruited adults aged 18 or older with LC. Four intervention arms were tested: multi-organ magnetic resonance imaging (MRI), digital rehabilitation, both, and neither.

The primary outcome was a reduction in fatigue measured by the Fatigue Assessment Scale (FAS) at 12 weeks. Secondary outcomes included FAS at 24 weeks and the EQ-5D-5L visual assessment scale at 12 and 24 weeks. Out of the 1,152 participants, 122 PCN clusters were randomly assigned to each arm. Baseline FAS scores were equivalent across groups, with 66.4% of participants being female.

The primary outcome was achieved in all arms, with a mean improvement of 4.5 points to 31.3 (s.d. 9.31) at 12 weeks. Compared to usual care, multi-organ MRI and digital rehabilitation showed modest effects on 12-week FAS, while their interaction had no significant impact. No serious adverse events were reported related to ICP interventions.

The study suggests that multidisciplinary holistic clinical care, including digital rehabilitation, can reduce fatigue in LC patients, regardless of multi-organ MRI. Further large, multi-site trials are necessary to optimize ICP interventions for LC. The research was identified as ISRCTN10665760.