Short- and Long-Term Efficacy of Modafinil at Improving Quality of Life in Stroke Survivors: A Post Hoc Sub Study of the Modafinil in Debilitating Fatigue After Stroke Trial
BackgroundThe phase-II modafinil in debilitating fatigue after stroke trial demonstrated that modafinil improves fatigue and quality of life in severely fatigued stroke survivors. For this study, we sought to examine the interaction between fatigue and quality of life after stroke and determine whet...
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doaj-fc76467d7c044e76999c37f25b83c35e2020-11-24T22:58:01ZengFrontiers Media S.A.Frontiers in Neurology1664-22952018-04-01910.3389/fneur.2018.00269362258Short- and Long-Term Efficacy of Modafinil at Improving Quality of Life in Stroke Survivors: A Post Hoc Sub Study of the Modafinil in Debilitating Fatigue After Stroke TrialThomas P. Lillicrap0Thomas P. Lillicrap1Christopher R. Levi2Christopher R. Levi3Elizabeth Holliday4Mark William Parsons5Mark William Parsons6Andrew Bivard7Andrew Bivard8Neurology Department, John Hunter Hospital, Newcastle, NSW, AustraliaHunter Medical Research Institute, Newcastle, NSW, AustraliaNeurology Department, John Hunter Hospital, Newcastle, NSW, AustraliaHunter Medical Research Institute, Newcastle, NSW, AustraliaHunter Medical Research Institute, Newcastle, NSW, AustraliaNeurology Department, John Hunter Hospital, Newcastle, NSW, AustraliaHunter Medical Research Institute, Newcastle, NSW, AustraliaNeurology Department, John Hunter Hospital, Newcastle, NSW, AustraliaHunter Medical Research Institute, Newcastle, NSW, AustraliaBackgroundThe phase-II modafinil in debilitating fatigue after stroke trial demonstrated that modafinil improves fatigue and quality of life in severely fatigued stroke survivors. For this study, we sought to examine the interaction between fatigue and quality of life after stroke and determine whether reducing fatigue resulted in improved quality of life. In addition, we followed up a subset of patients 12-months after the trial to assess the long-term outcomes of modafinil therapy.MethodsWe used linear regression to analyze interaction between baseline fatigue, as measured by the multidimensional fatigue inventory (MFI), and quality of life, as measured by the stroke-specific quality of life scale (SSQoL); and between changes in MFI and SSQoL during treatment. Patients also took part in semi-structured interviews and study assessments 12-months after trial completion to assess long-term patterns of modafinil use, safety and efficacy.ResultsMFI and SSQoL were significantly correlated at baseline (β = −1.975 95% CI −3.082, −0.869, p < 0.001), as were changes in MFI and SSQoL during treatment (β = −1.054 95% CI −1.556, −0.553, p < 0.001). 18 patients agreed to 12-month follow-up, of whom 5 had continued to use modafinil. Patients taking modafinil daily demonstrated sustained improvement of 33–38 points in MFI compared to baseline. Two adverse events were reported and there was no evidence of drug tolerance.ConclusionModafinil appears to be safe and, for at least some patients, effective long-term in fatigued stroke survivors. Alleviating fatigue has a significant relationship with improved quality of life.Clinical trial registrationhttps://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=368268, unique-identifier: ACTRN12615000350527.http://journal.frontiersin.org/article/10.3389/fneur.2018.00269/fullstrokestroke recoveryfatiguemodafinilquality of life |
collection |
DOAJ |
language |
English |
format |
Article |
sources |
DOAJ |
author |
Thomas P. Lillicrap Thomas P. Lillicrap Christopher R. Levi Christopher R. Levi Elizabeth Holliday Mark William Parsons Mark William Parsons Andrew Bivard Andrew Bivard |
spellingShingle |
Thomas P. Lillicrap Thomas P. Lillicrap Christopher R. Levi Christopher R. Levi Elizabeth Holliday Mark William Parsons Mark William Parsons Andrew Bivard Andrew Bivard Short- and Long-Term Efficacy of Modafinil at Improving Quality of Life in Stroke Survivors: A Post Hoc Sub Study of the Modafinil in Debilitating Fatigue After Stroke Trial Frontiers in Neurology stroke stroke recovery fatigue modafinil quality of life |
author_facet |
Thomas P. Lillicrap Thomas P. Lillicrap Christopher R. Levi Christopher R. Levi Elizabeth Holliday Mark William Parsons Mark William Parsons Andrew Bivard Andrew Bivard |
author_sort |
Thomas P. Lillicrap |
title |
Short- and Long-Term Efficacy of Modafinil at Improving Quality of Life in Stroke Survivors: A Post Hoc Sub Study of the Modafinil in Debilitating Fatigue After Stroke Trial |
title_short |
Short- and Long-Term Efficacy of Modafinil at Improving Quality of Life in Stroke Survivors: A Post Hoc Sub Study of the Modafinil in Debilitating Fatigue After Stroke Trial |
title_full |
Short- and Long-Term Efficacy of Modafinil at Improving Quality of Life in Stroke Survivors: A Post Hoc Sub Study of the Modafinil in Debilitating Fatigue After Stroke Trial |
title_fullStr |
Short- and Long-Term Efficacy of Modafinil at Improving Quality of Life in Stroke Survivors: A Post Hoc Sub Study of the Modafinil in Debilitating Fatigue After Stroke Trial |
title_full_unstemmed |
Short- and Long-Term Efficacy of Modafinil at Improving Quality of Life in Stroke Survivors: A Post Hoc Sub Study of the Modafinil in Debilitating Fatigue After Stroke Trial |
title_sort |
short- and long-term efficacy of modafinil at improving quality of life in stroke survivors: a post hoc sub study of the modafinil in debilitating fatigue after stroke trial |
publisher |
Frontiers Media S.A. |
series |
Frontiers in Neurology |
issn |
1664-2295 |
publishDate |
2018-04-01 |
description |
BackgroundThe phase-II modafinil in debilitating fatigue after stroke trial demonstrated that modafinil improves fatigue and quality of life in severely fatigued stroke survivors. For this study, we sought to examine the interaction between fatigue and quality of life after stroke and determine whether reducing fatigue resulted in improved quality of life. In addition, we followed up a subset of patients 12-months after the trial to assess the long-term outcomes of modafinil therapy.MethodsWe used linear regression to analyze interaction between baseline fatigue, as measured by the multidimensional fatigue inventory (MFI), and quality of life, as measured by the stroke-specific quality of life scale (SSQoL); and between changes in MFI and SSQoL during treatment. Patients also took part in semi-structured interviews and study assessments 12-months after trial completion to assess long-term patterns of modafinil use, safety and efficacy.ResultsMFI and SSQoL were significantly correlated at baseline (β = −1.975 95% CI −3.082, −0.869, p < 0.001), as were changes in MFI and SSQoL during treatment (β = −1.054 95% CI −1.556, −0.553, p < 0.001). 18 patients agreed to 12-month follow-up, of whom 5 had continued to use modafinil. Patients taking modafinil daily demonstrated sustained improvement of 33–38 points in MFI compared to baseline. Two adverse events were reported and there was no evidence of drug tolerance.ConclusionModafinil appears to be safe and, for at least some patients, effective long-term in fatigued stroke survivors. Alleviating fatigue has a significant relationship with improved quality of life.Clinical trial registrationhttps://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=368268, unique-identifier: ACTRN12615000350527. |
topic |
stroke stroke recovery fatigue modafinil quality of life |
url |
http://journal.frontiersin.org/article/10.3389/fneur.2018.00269/full |
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