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Clinical trial of a formal group fatigue program in multiple sclerosis |
Hugos CL, Copperman LF, Fuller BE, Yadav V, Lovera J, Bourdette DN |
Multiple Sclerosis 2010 Jun;16(6):724-732 |
clinical trial |
5/10 [Eligibility criteria: Yes; Random allocation: Yes; Concealed allocation: Yes; Baseline comparability: Yes; Blind subjects: No; Blind therapists: No; Blind assessors: No; Adequate follow-up: No; Intention-to-treat analysis: No; Between-group comparisons: Yes; Point estimates and variability: Yes. Note: Eligibility criteria item does not contribute to total score] *This score has been confirmed* |
Fatigue: take control is a novel program to teach fatigue management to people with multiple sclerosis (MS) following recommendations in the fatigue and multiple sclerosis guideline. Fatigue: take control includes six 2-hour group sessions with DVD viewing, discussion and homework and accompanying participant and leader workbooks. While many people have participated in fatigue: take control programs, its efficacy has not been determined. The objective of this study was to determine whether participation in fatigue: take control reduces fatigue and increases self-efficacy in people with MS. Thirty participants were randomly assigned to a group who immediately participated in the program (FTC) or a wait-list group (WL). The primary outcome was the Modified Fatigue Impact Scale (MFIS) and secondary outcomes were the Multiple Sclerosis Self-Efficacy Scale (MSSE) and the Fatigue Severity Scale (FSS). The MFIS was administered on 10 occasions. Other measures were administered on four occasions. A mixed model tested the effects using all observations. Compared with the WL, the FTC group had significantly more improvement on the MFIS (F[1,269] = 7.079, p = 0.008) and the MSSE (F[1,111] = 5.636, p = 0.019). No significant effect was found for the FSS. Across all visits, fatigue was significantly lower and self-efficacy was significantly higher for the FTC group compared with the WL group. This pilot study demonstrated significant effects in fatigue and self-efficacy among subjects taking the fatigue: take control program, suggesting that this comprehensive program based on the fatigue and multiple sclerosis guideline may be beneficial in MS.
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