Spinal Cord Injury Model Systems (SCIMS) - Utdanningsmodul
En ryggmargsskade (SCI) Stakeholder-godkjent utdanningsmodul for å redusere tidlig kardioendokrine helserisiko som oppstår etter ryggmargsskader.
The purpose of this study is to find out if receiving education regarding increased risks of cardiometabolic disease helps subjects understand these risks and how these risks participants' health.
Studieoversikt
Status
Intervensjon / Behandling
Studietype
Registrering (Antatt)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiekontakt
- Navn: Patricia Graham, MS
- Telefonnummer: 3052435119
- E-post: pgraham1@med.miami.edu
Studiesteder
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District of Columbia
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Washington D.C., District of Columbia, Forente stater, 20010
- Aktiv, ikke rekrutterende
- MedStar National Rehabilitation Network
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Florida
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Miami, Florida, Forente stater, 33136
- Aktiv, ikke rekrutterende
- University of Miami - Miami Project to Cure Paralysis
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Texas
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Dallas, Texas, Forente stater, 75246
- Rekruttering
- Baylor Scott & White Institute for Research
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Hovedetterforsker:
- Simon Driver, PhD
-
Ta kontakt med:
- Jacqueline Nguyen, MPH
- Telefonnummer: (469) 831-5321
- E-post: Jacqueline.Nguyen@BSWHealth.org
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-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
Inclusion Criteria:
- Men and Women with SCI/D aged 18-70 years.
- Neurologically complete and incomplete American Spinal Injury Association (ASIA) Impairment scale (AIS) A-D spinal cord levels C5 and below.
- Enrolled no later than 4 months following discharge from initial rehabilitation from SCI.
Exclusion Criteria:
- Pregnancy determined by urine testing in sexually active females.
- Cognitive impairment that compromises the legitimacy of consent.
- Grade 3-4 pressure injury at the time of study entry.
- Prisoners
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Forebygging
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: Paralyzed Veterans of America (PVA) Cardio-Metabolic Disease (CMD) Consumer Guide Group
Hard paper copy of as well as an electronic copy of the guide will be provided to subjects and study staff will provide a general review of the contents of the guide with subjects during their education sessions. Participants will be in this group for 6 months. |
Subject's will receive education on the PVA consumer guide 3 times over the course of the study. Each session will be approximately 10-15 minutes and will consist of a general review of the nutrition, exercise, and general healthy living guidelines content included. |
|
Aktiv komparator: WebMD Group
Subjects will be introduced to WebMD and its contents. A brief document will be provided that includes site summary and website. Study staff will provide a very brief overview of the site. Participants will be in this group for 6 months. |
Subject's will receive education on how to navigate the WebMD site and find information on health, exercise and nutrition 3 times over the course of the study. Each session will be approximately 10-15 minutes and will consist of a general review of the health and wellness content available on the website. At study completion, subjects in this group will be provided with the PVA guide and a brief orientation of the nutrition, exercise, and general healthy living guidelines content included in the guide. |
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Change in Effectiveness of education modules as determined in the Knowledge Test
Tidsramme: baseline, up to 6 months
|
Effectiveness as determined by the number of correct answers on the Knowledge Test where the higher number of correct answers indicates increased knowledge of the information provided. |
baseline, up to 6 months
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Change in Body Weight as determined by kilograms (kg)
Tidsramme: baseline, up to 6 months
|
Body weight will be measured in kilograms |
baseline, up to 6 months
|
|
Change in Body composition as determined by Dual X-ray Absorptiometry (DXA)
Tidsramme: baseline, up to 6 months
|
Body composition will be measured in grams using DXA |
baseline, up to 6 months
|
|
Change in Body composition as determined by Dual X-ray Absorptiometry (DXA) in Percentage
Tidsramme: baseline, up to 6 months
|
Body composition will be expressed as a percentage of body fat (BF) using DXA |
baseline, up to 6 months
|
|
Change in sugar metabolism as determined by Insulin resistance (IR)
Tidsramme: baseline, up to 6 months
|
Sugar metabolism will be determined as IR calculated using the formula (fasting serum glucose*fasting serum insulin/22.5). Lower values indicate a higher degree of insulin sensitivity. Fasting values are obtained from blood samples |
baseline, up to 6 months
|
|
Change in Quality of Life (QoL) as measured by Quality Index Spinal Cord Injury Version III
Tidsramme: baseline, up to 6 months
|
A composite score will be obtained to assess change in QoL using a six-point Likert scale. Scores for satisfaction section range from "1- very satisfied" to "6-very dissatisfied". On the important section scoring ranges from "1-very important" to "6- very unimportant" |
baseline, up to 6 months
|
|
Change in Quality of Life (QoL) Using the International Spinal Cord Injury Basic Data Set
Tidsramme: baseline, up to 6 months
|
QoL values will be determined using a scale ranging from 0 (completely dissatisfied) to 10 (completely satisfied). |
baseline, up to 6 months
|
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Change in heart disease risk as determined by cholesterol
Tidsramme: baseline, up to 6 months.
|
Risk of heart disease will be measured from a blood sample in mg/dL |
baseline, up to 6 months.
|
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Change in heart disease risk as determined by blood pressure (BP)
Tidsramme: baseline, up to 6 months.
|
BP will be measured in mmHg using an arm cuff |
baseline, up to 6 months.
|
Samarbeidspartnere og etterforskere
Sponsor
Samarbeidspartnere
Etterforskere
- Hovedetterforsker: Gary Farkas, PhD, University of Miami
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Antatt)
Studiet fullført (Antatt)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
- Sykdommer i sentralnervesystemet
- Sykdommer i nervesystemet
- Sår og skader
- Ernæringsforstyrrelser
- Metabolske sykdommer
- Overernæring
- Kroppsvekt
- Glukosemetabolismeforstyrrelser
- Insulinresistens
- Hyperinsulinisme
- Overvektig
- Traumer, nervesystemet
- Ryggmargssykdommer
- Patologiske tilstander, tegn og symptomer
- Ernæringsmessige og metabolske sykdommer
- Tegn og symptomer
- Overvekt
- Metabolsk syndrom
- Ryggmargsskader
Andre studie-ID-numre
- 20230202
Plan for individuelle deltakerdata (IPD)
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Legemiddel- og utstyrsinformasjon, studiedokumenter
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