Examining the Effects of a Telehealth Self-management Intervention in Multiple Sclerosis
16 december 2021 bijgewerkt door: Matthew Plow, Case Western Reserve University
Examining the Effects of Physical Activity Promotion, Fatigue Management Education, and Social Support Using a Telehealth Intervention Approach Among Adults With Multiple Sclerosis
The objective of this study is to conduct a randomized controlled trial to examine the effectiveness of a telehealth intervention that supports individuals in managing fatigue and increasing physical activity (PA) behavior in individuals with multiple sclerosis (MS).
The hypothesis is that a fatigue management plus physical activity intervention will significantly improve fatigue, quality of life, physical function, and community integration.
Studie Overzicht
Toestand
Voltooid
Conditie
Gedetailleerde beschrijving
The long-term objective of this study is to use a telehealth intervention approach to reduce the devastating effects of the reciprocal relationship between fatigue and inactivity on quality of life and participation in life roles in people with multiple sclerosis (MS).
Chronic fatigue and inactivity are common problems in persons with MS, and the reciprocal relationship between fatigue and inactivity may have negative synergistic effects on quality of life and participation in life roles.
The proposed study is novel in that it represents a multi-disciplinary effort to merge two promising lines of MS research: fatigue management and PA promotion.
The proposed fatigue management plus PA intervention (FM+) will consist of incorporating a modified teleconference version of Packer et al.'s empirically-tested Fatigue Management program with innovative, yet simple approaches to promote lifestyle PA by encouraging goal-setting and self-monitoring with a pedometer.
Ambulatory individuals with MS will be recruited and randomized into one of three telehealth interventions: social support intervention, PA-only intervention, and FM+.
Studietype
Ingrijpend
Inschrijving (Werkelijk)
208
Fase
- Niet toepasbaar
Contacten en locaties
In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.
Studie Locaties
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Ohio
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Cleveland, Ohio, Verenigde Staten, 44106
- Case Western Reserve University
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Deelname Criteria
Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
18 jaar tot 65 jaar (Volwassen, Oudere volwassene)
Accepteert gezonde vrijwilligers
Nee
Geslachten die in aanmerking komen voor studie
Allemaal
Beschrijving
Inclusion Criteria:
- A physician-confirmed diagnosis of MS
Exclusion Criteria:
- Exercise more than 90 minutes per week
- Pregnant
- Metabolic or cardiopulmonary disease that puts patient at high risk for engaging in a home exercise program (patients with controlled diabetes and high blood pressure will still be considered eligible)
- Four or more falls in the past 6 months
- Be able to walk 25 feet with or without a cane or walker
- Severe cognitive deficits
- A condition besides MS that had lead to hospitalization in the past year
Studie plan
Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Ondersteunende zorg
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
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Actieve vergelijker: Social Support Program
The social support program will consist of 6 weekly, 1.25-hours, teleconference calls with 4 biweekly, 15 minute, follow-up one-to-one phone calls.
Topics will include information on MS, disease modifying medications, preventive screening, community organizations, nutrition, cognitive problems, and hiring an aide.
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The social support program will consist of 6 weekly, 1.25-hours, teleconference calls with 4 biweekly, 15 minute, follow-up one-to-one phone calls.
Topics will include information on MS, disease modifying medications, preventive screening, community organizations, nutrition, cognitive problems, and hiring an aide.
Andere namen:
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Actieve vergelijker: Physical Activity Program
The physical activity education program will consist of 3 weekly, 1.25-hours, teleconference calls with 4 biweekly, 15 minute, follow-up one-to-one phone calls.
Subjects in this program will learn MS-specific benefits of physical activity, how to use a pedometer to self-monitor their progress for increasing physical activity levels, and learn strategies for maintaining their progress in the program.
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The physical activity education program will consist of 3 weekly, 1.25-hours, teleconference calls with 4 biweekly, 15 minute, follow-up one-to-one phone calls.
Subjects in this program will learn MS-specific benefits of physical activity, how to use a pedometer to self-monitor their progress for increasing physical activity levels, and learn strategies for maintaining their progress in the program.
Andere namen:
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Actieve vergelijker: Physical Activity Plus Fatigue
The physical activity plus fatigue management education program will consist of 6 weekly, 1.25-hours, teleconference calls with 4 biweekly, 15 minute, follow-up one-to-one phone calls.
Subjects in this program will learn MS-specific benefits of physical activity, how to use a pedometer to self-monitor their progress for increasing physical activity levels, and learn strategies for maintaining their progress in the program.
In addition, subjects in this course will learn strategies to reduce fatigue, such as taking rest breaks and re-arranging workspace.
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The physical activity plus fatigue management education program will consist of 6 weekly, 1.25-hours, teleconference calls with 4 biweekly, 15 minute, follow-up one-to-one phone calls.
Subjects in this program will learn MS-specific benefits of physical activity, how to use a pedometer to self-monitor their progress for increasing physical activity levels, and learn strategies for maintaining their progress in the program.
In addition, subjects in this course will learn strategies to reduce fatigue, such as taking rest breaks and re-arranging workspace.
Andere namen:
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Changes from baseline in physical activity levels
Tijdsspanne: Each patient will be given the assessments at 3 points during the study, at baseline, interim test (an average of 12 weeks from baseline) and at posttest (an average of 24 weeks from baseline).
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Physical activity behavior will be measured with the Godin Leisure-Time Exercise Questionnaire and accelerometers.
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Each patient will be given the assessments at 3 points during the study, at baseline, interim test (an average of 12 weeks from baseline) and at posttest (an average of 24 weeks from baseline).
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Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Changes from baseline in fatigue levels
Tijdsspanne: Each patient will be given the questionnaire at 3 points during the study, at baseline, interim test (an average of 12 weeks from baseline) and at posttest (an average of 24 weeks from baseline).
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Fatigue will be measured with the Fatigue Impact Scale.
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Each patient will be given the questionnaire at 3 points during the study, at baseline, interim test (an average of 12 weeks from baseline) and at posttest (an average of 24 weeks from baseline).
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Changes from baseline in quality of life
Tijdsspanne: Each patient will be given the questionnaires at 3 points during the study, at baseline, interim test (an average of 12 weeks from baseline) and at posttest (an average of 24 weeks from baseline).
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The SF-12, Multiple Sclerosis Impact Scale, and Community Participation Indicator (CPI) will be administered.
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Each patient will be given the questionnaires at 3 points during the study, at baseline, interim test (an average of 12 weeks from baseline) and at posttest (an average of 24 weeks from baseline).
|
Medewerkers en onderzoekers
Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.
Sponsor
Medewerkers
Onderzoekers
- Hoofdonderzoeker: Matthew A Plow, PhD, Case Western Reserve University
Publicaties en nuttige links
De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.
Algemene publicaties
- Plow M, Motl RW, Finlayson M, Bethoux F. Response heterogeneity in a randomized controlled trial of telerehabilitation interventions among adults with multiple sclerosis. J Telemed Telecare. 2022 Oct;28(9):642-652. doi: 10.1177/1357633X20964693. Epub 2020 Oct 25.
- Plow M, Motl RW, Finlayson M, Bethoux F. Intervention Mediators in a Randomized Controlled Trial to Increase Physical Activity and Fatigue Self-management Behaviors Among Adults With Multiple Sclerosis. Ann Behav Med. 2020 Feb 21;54(3):213-221. doi: 10.1093/abm/kaz033.
- Plow M, Finlayson M, Liu J, Motl RW, Bethoux F, Sattar A. Randomized Controlled Trial of a Telephone-Delivered Physical Activity and Fatigue Self-management Interventions in Adults With Multiple Sclerosis. Arch Phys Med Rehabil. 2019 Nov;100(11):2006-2014. doi: 10.1016/j.apmr.2019.04.022. Epub 2019 Jun 21.
- Plow M, Finlayson M, Motl RW, Bethoux F. Randomized controlled trial of a teleconference fatigue management plus physical activity intervention in adults with multiple sclerosis: rationale and research protocol. BMC Neurol. 2012 Oct 16;12:122. doi: 10.1186/1471-2377-12-122.
Studie record data
Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.
Bestudeer belangrijke data
Studie start
1 juli 2011
Primaire voltooiing (Werkelijk)
1 februari 2017
Studie voltooiing (Werkelijk)
1 februari 2017
Studieregistratiedata
Eerst ingediend
4 april 2012
Eerst ingediend dat voldeed aan de QC-criteria
4 april 2012
Eerst geplaatst (Schatting)
6 april 2012
Updates van studierecords
Laatste update geplaatst (Werkelijk)
6 januari 2022
Laatste update ingediend die voldeed aan QC-criteria
16 december 2021
Laatst geverifieerd
1 december 2021
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- 03-14-19
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Nee
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
Nee
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