Evaluation of a Web-Based Fall Prevention Program on People With Multiple Sclerosis
5. april 2018 oppdatert av: Michelle Cameron, Oregon Health and Science University
This study evaluates the effectiveness of a web-based fall prevention program called Free From Falls Online (FFFO) on people with multiple sclerosis.
Studieoversikt
Status
Fullført
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
The overarching goal of this study is to evaluate the effectiveness and impact of an online self-management program for preventing falls among people with multiple sclerosis (PwMS).
To accomplish this objective, the investigators have designed a web-based fall prevention program called Free From Falls Online (FFFO), based on the traditionally in-person program developed by the National Multiple Sclerosis Society.
The specific aims of this study are three-fold: (1) to evaluate the effectiveness of an online fall prevention self-education program by comparing fall frequency between participants and controls; (2) evaluate the impact of FFFO by comparing patient reported measures of physical function, fatigue, self-efficacy, psychosocial illness impact, social participation and satisfaction, and perception of global health between participants and controls; (3) and to determine usability of and satisfaction with FFFO.
Studietype
Intervensjonell
Registrering (Faktiske)
30
Fase
- Ikke aktuelt
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
-
-
Oregon
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Portland, Oregon, Forente stater, 97239
- Oregon Health Sciences University
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Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
18 år og eldre (Voksen, Eldre voksen)
Tar imot friske frivillige
Nei
Kjønn som er kvalifisert for studier
Alle
Beskrivelse
Inclusion Criteria:
- MS of any type with no relapse in the previous month
- Self-reported history of 2 or more falls in the previous 2 months
- Ability to walk at least 100 meters with intermittent or unilateral constant assistance (Expanded Disability Severity Scale (EDSS) step <6.0)
- Daily access a computer and willingness to respond to a daily survey
Exclusion Criteria:
- Medical conditions that would preclude reliable participation or increases risk for injury during the program
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Enkelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
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Aktiv komparator: Free From Falls
Subjects in the active group will participate in the Free From Falls Online Program consisting of 8 weekly 30 minute webinars providing education about risk factors for falls and fall prevention strategies; self-assessment exercises to evaluate understanding of the material; video-based exercise program targeting balance, posture, strength and flexibility to be performed at least 3 times per week; supplementary, downloadable printed material for both education and exercise; and a social forum to allow participants to interact with each other.
|
Subjects in the active group will participate in the Free From Falls Online Program consisting of 8 weekly 30 minute webinars providing education about risk factors for falls and fall prevention strategies; self-assessment exercises to evaluate understanding of the material; video-based exercise program targeting balance, posture, strength and flexibility to be performed at least 3 times per week; supplementary, downloadable printed material for both education and exercise; and a social forum to allow participants to interact with each other.
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|
Placebo komparator: Waitlist
Subjects in the waitlist control condition will receive an educational brochure developed by the National Multiple Sclerosis Society called "Minimizing Your Risk of Falls: A Guide for People with MS," which includes information on identifying risk factors for falling and fall risk management approaches with no exercise component; will inform their provider that they have fallen at least twice in the previous 2 months and discuss subsequent falls over the course of the 5-month study; and will be invited to participate in the Free From Falls Online Program at study completion.
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Subjects in the waitlist control condition will receive an educational brochure developed by the National Multiple Sclerosis Society called "Minimizing Your Risk of Falls: A Guide for People with MS," which includes information on identifying risk factors for falling and fall risk management approaches with no exercise component; will inform their provider that they have fallen at least twice in the previous 2 months and discuss subsequent falls over the course of the 5-month study; and will be invited to participate in the Free From Falls Online Program at study completion.
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Difference in mean change in total falls between intervention and control arms
Tidsramme: 5 months
|
To determine if participation in FFFO is associated with decreased frequency of falls, subjects will be randomly assigned to either the active intervention group or the waitlist control group.
All subjects will prospectively document the number and circumstances of their falls for 5 months through the use of an electronic survey, to include the 8 weeks of the active or control intervention and 3-month follow-up.
The primary outcome will be the difference in fall frequency between active and control subjects.
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5 months
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Difference in patient reported outcomes including physical function, fatigue, self efficacy, psychosocial illness impact, social participation and satisfaction, and perception of global health between intervention and control arms.
Tidsramme: 5 months
|
To determine if participation in FFFO is associated with improvement in patient reported outcomes, subjects will be randomly assigned to either the active intervention group or the waitlist control group.
Outcomes will be measured through the use of the Patient Reported Outcomes Measurement Information System (PROMIS) which has been validated in people with multiple sclerosis.
All subjects will complete the questionnaires at baseline, at 8 weeks and at 3 month follow-up.
Scores will be compared between active and control subjects.
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5 months
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Quantitative assessment of the web-based program
Tidsramme: 8 weeks
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To determine usability and satisfaction with FFFO, subjects in the active group will complete a computer-based questionnaire at the end of the program.
The investigators will quantitatively evaluate participant assessment of the FFFO program through the use of a 5-point Likert scale.
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8 weeks
|
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Qualitative assessment of the web-based program
Tidsramme: 8 weeks
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To determine usability and satisfaction with FFFO, subjects in the active group will complete a computer-based questionnaire at the end of the program.
The investigators will qualitatively evaluate participant assessment of the FFFO program through the use of free-text responses.
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8 weeks
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Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Samarbeidspartnere
Etterforskere
- Hovedetterforsker: Michelle H Cameron, MD, Portland VA Medical Center
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Faktiske)
15. februar 2017
Primær fullføring (Faktiske)
25. januar 2018
Studiet fullført (Faktiske)
25. januar 2018
Datoer for studieregistrering
Først innsendt
22. august 2016
Først innsendt som oppfylte QC-kriteriene
25. august 2016
Først lagt ut (Anslag)
31. august 2016
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
9. april 2018
Siste oppdatering sendt inn som oppfylte QC-kriteriene
5. april 2018
Sist bekreftet
1. april 2018
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 00015595
Plan for individuelle deltakerdata (IPD)
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Studerer et amerikansk FDA-regulert medikamentprodukt
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