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| A multicenter randomized controlled trial of two group education programs for fatigue in multiple sclerosis: long-term (12-month) follow-up at one site |
| Hugos CL, Cameron MH, Chen Z, Chen Y, Bourdette D |
| Multiple Sclerosis Journal 2019 May;25(6):871-875 |
| clinical trial |
| 3/10 [Eligibility criteria: No; Random allocation: Yes; Concealed allocation: No; Baseline comparability: No; Blind subjects: No; Blind therapists: No; Blind assessors: No; Adequate follow-up: Yes; Intention-to-treat analysis: Yes; Between-group comparisons: No; Point estimates and variability: No. Note: Eligibility criteria item does not contribute to total score] *This score has been confirmed* |
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BACKGROUND: A four-site RCT of fatigue: take control (FTC), a multicomponent group program, found no significant differences from a control program, MS: take control (MSTC), in fatigue on the Modified Fatigue Impact Scale (MFIS) through 6 months. OBJECTIVE: Assess FTC for a delayed effect on fatigue. METHODS: Of 78 subjects at one site, 74 randomized to FTC or MSTC completed the MFIS at 12 months. RESULTS: Compared to baseline, FTC produced greater improvements in MFIS scores than MSTC (FTC -8.9 (confidence interval (CI) 32.2 to 45), MSTC -2.5 (CI 39.6 to 47.7), p = 0.03) at 12 months. CONCLUSION: The delayed effect of FTC on fatigue suggests the need for longer follow-up when assessing interventions for fatigue.
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