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REFRESH protocol: a non-inferiority randomised clinical trial comparing internet and teleconference to in-person 'Managing Fatigue' interventions on the impact of fatigue among persons with multiple sclerosis.

ABSTRACT: INTRODUCTION:Multiple sclerosis (MS) is an immune-mediated disease of the central nervous system. It is considered a major cause of non-traumatic disability in young adults. One of the most common and disabling symptoms of MS is fatigue. MS fatigue can impact all aspects of quality of life, including physical, mental and social function. Fortunately, fatigue self-management interventions, such as 'Managing Fatigue: A 6?week energy conservation course', can decrease the impact of fatigue and improve health-related quality of life. The purpose of this study is to compare three modes of delivering the Managing Fatigue intervention-two remote delivery formats (teleconference and internet) and one in-person format-on perceptions of fatigue and its impact on physical, mental and social function. METHODS AND ANALYSIS:A non-inferiority randomised clinical trial is being conducted to compare the three delivery formats (1:1:1 allocation ratio) among 582 participants with MS living in the Midwestern and Northeastern United States. The hypothesis is that teleconference and internet versions of the intervention are non-inferior to the traditional mode of clinical service delivery (ie, one to one, in person) in terms of the primary outcome of self-reported fatigue impact (ie, Fatigue Impact Scale) and the secondary outcome of health-related quality of life (ie, Multiple Sclerosis Impact Scale). Outcomes are being measured at baseline, 2?months, 3?months and 6?months. The primary analysis tool will be linear mixed effects model. The prespecified inferiority margin for the primary outcome is 10 points. We will also examine whether baseline characteristics (eg, sociodemographic) moderate outcomes of the Managing Fatigue intervention and whether changes in self-efficacy and fatigue self-management behaviours mediate changes in outcomes. ETHICS AND DISSEMINATION:The protocol is approved centrally by the institutional review board at Case Western Reserve University. Eligible participants give consent before being enrolled and randomised into the study. The study results will be disseminated through relevant advocacy organisations, newsletters to participants, publication in peer-reviewed journals and presentations at scientific conferences. TRIAL REGISTRATION NUMBER:NCT03550170; Pre-results.

SUBMITTER: Plow M

PROVIDER: S-EPMC7430436 | biostudies-literature | 2020 Aug

REPOSITORIES: biostudies-literature

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REFRESH protocol: a non-inferiority randomised clinical trial comparing internet and teleconference to in-person 'Managing Fatigue' interventions on the impact of fatigue among persons with multiple sclerosis.

Plow Matthew M Packer Tanya T Mathiowetz Virgil G VG Preissner Kathy K Ghahari Setareh S Sattar Abdus A Bethoux Francois F Finlayson Marcia M

BMJ open 20200816 8

<h4>Introduction</h4>Multiple sclerosis (MS) is an immune-mediated disease of the central nervous system. It is considered a major cause of non-traumatic disability in young adults. One of the most common and disabling symptoms of MS is fatigue. MS fatigue can impact all aspects of quality of life, including physical, mental and social function. Fortunately, fatigue self-management interventions, such as '<i>Managing Fatigue: A 6 week energy conservation course'</i>, can decrease the impact of f ...[more]

PMID: 32801193

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Project description:BackgroundFatigue is a common experience among persons diagnosed with multiple sclerosis (MS). Fatigue negatively influences quality of life, interferes with activities of daily living, and impairs the ability to maintain gainful employment. Mechanisms underlying the pathophysiologic determinants of fatigue in MS are poorly understood, and effective treatments to manage fatigue present a challenge. Although the use of pharmacologic therapies is recommended to treat symptomatic fatigue, undertreatment of fatigue is common. Better long-term management and symptomatic relief may be provided by the use of nonpharmacologic treatments such as increased physical activity, energy conservation, and cognitive behavioral therapy.MethodsThe purpose of this study was to explore the physical, cognitive, and psychosocial dimensions of fatigue impact among persons with long-standing MS-defined here as having been diagnosed with MS for 17 years or more. A sample of 331 participants with MS completed surveys measuring fatigue impact, MS-related functional limitation, depressive symptoms, barriers to health promotion, personal resources, and health promoting behaviors.ResultsMS-related functional limitation and depressive symptoms were the strongest predictors of fatigue impact. MS-related functional limitation explained the greatest amount of variance in models predicting physical and psychosocial fatigue impact, whereas depressive symptoms explained the most variance in models predicting total and cognitive fatigue impact. Barriers to health promotion explained the least amount of variance among the models. Personal resources and health promoting behaviors were not significant predictors of fatigue impact in this study.ConclusionInterventions aimed at reducing MS-related functional limitations, depressive symptoms, and barriers to health promotion may have beneficial influences on fatigue impact, whereas actions designed to promote personal resource adequacy as well as engagement in health promoting behaviors may not translate into improvements in fatigue impact in persons with MS.

Project description:BackgroundInternet-based interventions (IBIs) are as efficient as face-to-face psychotherapy for a variety of mental health disorders, including complicated grief. Most evidence stems from guided IBIs. However, recent research indicates that the benefit of guidance is lower in more interactive IBIs. As such, providing guidance only to people requiring it (guidance on demand) appears a cost-effective solution. This is particularly important to develop given the recent rise in grief symptoms in the context of the COVID-19 pandemic. This paper presents the protocol of a randomized controlled trial comparing the efficacy and adherence rate of 2 IBIs for grief-related symptoms after the loss a close one following death or romantic separation, using a guidance on demand framework. LIVIA 2.0 was developed based on theoretical and empirical findings on grief processes and IBIs, and it will be compared to LIVIA 1 that has already demonstrated its efficacy.ObjectiveOur main hypotheses are that LIVIA 1 (control condition) and LIVIA 2.0 (experimental condition) increase participants' well-being and decrease their distress at posttest and at follow-up, that LIVIA 2.0 is more efficient than LIVIA 1 for all outcomes, and that LIVIA 2.0 has less dropouts than LIVIA 1.MethodsOutcomes will be assessed at pretest, posttest (12 weeks later), and follow-up (24 weeks later). We will recruit 234 participants through a variety of means, including social media and contacts with the press. Primary outcomes are grief symptoms, depressive symptoms, and eudemonic well-being. Secondary outcomes are anxiety symptoms, grief coping strategies, aspects related to self-identity reorganization, and program satisfaction. LIVIA 2.0 participants will additionally undergo a weekly mood and grief symptom monitoring, allowing us to explore the short-term efficacy of the sessions.ResultsThe creation and development of the content of LIVIA 2.0 was completed during the first phase of the project. Participant recruitment will begin in May 2022 and will last until January 2023.ConclusionsThis study will emphasize the relevance of the innovations included in LIVIA 2.0 regarding the efficacy and dropout rate of IBIs for grief symptoms and will allow investigations on how these changes impact the demand for guidance. In the current postpandemic times, developing and assessing IBIs targeting grief symptoms are particularly critical given the rise in grief-related symptoms.Trial registrationclinicaltrials.gov NCT05219760; https://tinyurl.com/3dzztjts.International registered report identifier (irrid)PRR1-10.2196/39026.

Project description:BACKGROUND:Fatigue is one of the most disabling symptoms of multiple sclerosis (MS) and contributes to diminishing quality of life. Although currently available interventions have had limited success in relieving MS-related fatigue, clinically significant reductions in perceived fatigue severity have been reported in a multimodal intervention pilot study that included a Paleolithic diet in addition to stress reduction, exercise, and electrical muscle stimulation. An optimal dietary approach to reducing MS-related fatigue has not been identified. To establish the specific effects of diet on MS symptoms, this study focuses on diet only instead of the previously tested multimodal intervention by comparing the effectiveness of two dietary patterns for the treatment of MS-related fatigue. The purpose of this study is to determine the impact of a modified Paleolithic and low saturated fat diet on perceived fatigue (primary outcome), cognitive and motor symptoms, and quality of life in persons with relapsing-remitting multiple sclerosis (RRMS). METHODS/DESIGN:This 36-week randomized clinical trial consists of three 12-week periods during which assessments of perceived fatigue, quality of life, motor and cognitive function, physical activity and sleep, diet quality, and social support for eating will be collected. The three 12-week periods will consist of the following: 1. OBSERVATION:Participants continue eating their usual diet. 2. INTERVENTION:Participants will be randomized to a modified Paleolithic or low saturated fat diet for the intervention period. Participants will receive support from a registered dietitian (RD) through in-person coaching, telephone calls, and emails. 3. FOLLOW-UP:Participants will continue the study diet for an additional 12 weeks with minimal RD support to assess the ability of the participants to sustain the study diet on their own. DISCUSSION:Because fatigue is one of the most common and disabling symptoms of MS, effective management and reduction of MS-related fatigue has the potential to increase quality of life in this population. The results of this study will add to the evidence base for providing dietary recommendations to treat MS-related fatigue and other symptoms associated with this disease. TRIAL REGISTRATION:ClinicalTrials.gov, NCT02914964 . Registered on 24 August 2016.

Dataset Information

REFRESH protocol: a non-inferiority randomised clinical trial comparing internet and teleconference to in-person 'Managing Fatigue' interventions on the impact of fatigue among persons with multiple sclerosis.

Publications

REFRESH protocol: a non-inferiority randomised clinical trial comparing internet and teleconference to in-person 'Managing Fatigue' interventions on the impact of fatigue among persons with multiple sclerosis.

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