A Non-Inferiority Randomized Clinical Trial Comparing Three Delivery Formats of a Rehabilitation Intervention to Reduce Fatigue among People with Multiple Sclerosis.
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- Record sourced from PubMed, PMID 41242677.
- Also identified by DOI 10.1016/j.apmr.2025.10.022.
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Abstract
To compare three delivery formats of a rehabilitation intervention in reducing fatigue: 1) synchronous group sessions via audio-only teleconference, 2) asynchronous group sessions delivered online, and 3) synchronous one-to-one sessions delivered in-person or videoconference. The primary hypothesis was that group-based teleconference and internet formats would be non-inferior to the one-to-one format. Decentralized, randomized, non-inferiority trial with assessments at baseline, 2, 3, and 6 months. Community-based adults in Midwestern United States PARTICIPANTS: 590 adults with multiple sclerosis (MS) INTERVENTIONS: An occupational therapist-led intervention aimed at supporting self-management of fatigue. Generalized estimating equations tested the primary hypothesis using a 10-point non-inferiority margin on the Fatigue Impact Scale (FIS). Moderation and mediation analyses explored the effects of demographic, health, and psychosocial factors. GEE analysis showed that the teleconference format had higher (worse) estimated FIS scores compared to the one-to-one format, with values of 5.96 (1.80, 10.12) at 2 months, 8.73 (4.52, 12.94) at 3 months, and 4.89 (0.67, 9.12) at 6 months. The internet format also had higher FIS scores, with estimates of 9.94 (5.68, 14.20) at 2 months, 9.09 (4.80, 13.38) at 3 months, and 6.12 (1.81, 10.44) at 6 months. Moderation analysis indicated that participants from racial and ethnic minority groups, those with lower education levels, and individuals experiencing more anxiety, sleep disturbance, or comorbidities derived better improvements in FIS from the one-to-one format. The number of logins significantly mediated fatigue improvements in the internet format, while outcome expectations significantly mediated the teleconference format. The upper bound CI for teleconference and internet formats exceeded the non-inferiority margin at most time points, indicating the hypothesis was neither supported nor rejected. While teleconference and internet formats may offer broader accessibility, potential effectiveness trade-offs should be considered, especially for individuals needing intense, personalized care.