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

Area of Science:

• Clinical Medicine
• Public Health
• Medical Research

Background:

• Integrated care pathways (ICPs) are effective for managing long-term conditions but haven't been evaluated for Long COVID (LC).
• LC affects numerous individuals, necessitating effective and scalable management strategies.
• Multidisciplinary care is crucial for complex, chronic conditions like LC.

Purpose of the Study:

• To investigate the effectiveness of ICP interventions for Long COVID (LC).
• To evaluate the impact of multi-organ MRI and digital rehabilitation on LC symptoms.
• To assess the feasibility of large, multi-site clinical trials for LC interventions.

Main Methods:

• A phase 3, cluster-randomized, multicenter clinical trial involving 122 primary care network (PCN) clusters across 6 NHS LC clinics in England.
• Intervention arms included multi-organ MRI, digital rehabilitation, both, or usual care (neither).
• The primary endpoint was the mean Fatigue Assessment Scale (FAS) at 12 weeks, with secondary endpoints including FAS at 24 weeks and EQ-5D-5L scores.

Main Results:

• All intervention arms showed improvement in FAS scores at 12 weeks (mean score reduced from 35.8 to 31.3).
• Compared to usual care, multi-organ MRI (-0.18), digital rehabilitation (-0.53), and their interaction (-0.17) did not show statistically significant differences in 12-week FAS.
• No serious adverse events related to ICP interventions were reported.

Conclusions:

• Multidisciplinary holistic care is associated with fatigue reduction in LC patients, independent of multi-organ MRI.
• Digital rehabilitation may be beneficial for the longer-term management of LC.
• Large-scale trials for optimal ICP interventions in LC are feasible, but further research is needed.