Cinda L Hugos1, Zunqiu Chen2, Yiyi Chen2, Aaron P Turner3, Jodie Haselkorn3, Toni Chiara4, Sean McCoy4, Christopher T Bever5, Michelle H Cameron1, Dennis Bourdette1. 1. VA Portland Health Care System, Oregon Health & Science University, Portland, OR, USA. 2. OHSU Biostatistics Design Program, OHSU-PSU School of Public Health, Oregon Health & Science University, Portland, OR, USA. 3. VA Puget Sound Health Care System, University of Washington Department of Rehabilitation Medicine, Seattle, WA, USA. 4. North Florida/South Georgia Veterans Health System, Gainesville, FL, USA. 5. VA Maryland Health Care System, University of Maryland, Department of Neurology Baltimore, MD, USA.
Abstract
BACKGROUND:Fatigue occurs in 75%-95% of people with multiple sclerosis (MS) and is frequently reported as the most disabling symptom. A multicomponent group program of six weekly 2-hour sessions, Fatigue: Take Control (FTC), was developed from an international MS fatigue management guideline. OBJECTIVE: To determine whether FTC is associated with greater improvements in fatigue than MS: Take Control (MSTC), a similarly structured general MS education program. METHODS: This four-site, parallel, single-blind, randomized controlled trial compared FTC and MSTC in 204 ambulatory participants with MS. The primary outcome, the Modified Fatigue Impact Scale (MFIS), and secondary outcomes of self-efficacy, physical activity, sleep, and medications were assessed at baseline, program completion, and 3 and 6 months later. RESULTS:Mean MFIS scores improved in both groups between baseline and program completion (FTC -4.4, p < 0.001; MSTC -3.8, p < 0.001), between baseline and 3 months after program completion (FTC -3.2, p = 0.01; MSTC -3.3, p = 0.01), and between baseline and 6 months after program completion (FTC -5.2, p < 0.001; MSTC -4.8, p < 0.001). These improvements were not statistically different between groups ( p = 0.64, 0.92, and 0.82, respectively). CONCLUSION: Participation in FTC modestly improved self-reported fatigue for up to 6 months. This improvement did not differ significantly from that occurring with the control program.
RCT Entities:
BACKGROUND:Fatigue occurs in 75%-95% of people with multiple sclerosis (MS) and is frequently reported as the most disabling symptom. A multicomponent group program of six weekly 2-hour sessions, Fatigue: Take Control (FTC), was developed from an international MS fatigue management guideline. OBJECTIVE: To determine whether FTC is associated with greater improvements in fatigue than MS: Take Control (MSTC), a similarly structured general MS education program. METHODS: This four-site, parallel, single-blind, randomized controlled trial compared FTC and MSTC in 204 ambulatory participants with MS. The primary outcome, the Modified Fatigue Impact Scale (MFIS), and secondary outcomes of self-efficacy, physical activity, sleep, and medications were assessed at baseline, program completion, and 3 and 6 months later. RESULTS: Mean MFIS scores improved in both groups between baseline and program completion (FTC -4.4, p < 0.001; MSTC -3.8, p < 0.001), between baseline and 3 months after program completion (FTC -3.2, p = 0.01; MSTC -3.3, p = 0.01), and between baseline and 6 months after program completion (FTC -5.2, p < 0.001; MSTC -4.8, p < 0.001). These improvements were not statistically different between groups ( p = 0.64, 0.92, and 0.82, respectively). CONCLUSION: Participation in FTC modestly improved self-reported fatigue for up to 6 months. This improvement did not differ significantly from that occurring with the control program.
Authors: Anthony M Harrison; Reza Safari; Tom Mercer; Federica Picariello; Marietta L van der Linden; Claire White; Rona Moss-Morris; Sam Norton Journal: Mult Scler Date: 2021-04-20 Impact factor: 6.312