Spinal Cord Injury Model Systems (SCIMS) - Uddannelsesmodul
Et rygmarvsskade (SCI) Stakeholder-godkendt uddannelsesmodul til at afbøde tidlige kardioendokrine sundhedsrisici, der opstår efter rygmarvsskader.
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.
Studieoversigt
Status
Betingelser
Intervention / Behandling
Undersøgelsestype
Tilmelding (Anslået)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiekontakt
- Navn: Patricia Graham, MS
- Telefonnummer: 3052435119
- E-mail: pgraham1@med.miami.edu
Studiesteder
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District of Columbia
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Washington D.C., District of Columbia, Forenede Stater, 20010
- Aktiv, ikke rekrutterende
- MedStar National Rehabilitation Network
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Florida
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Miami, Florida, Forenede Stater, 33136
- Aktiv, ikke rekrutterende
- University of Miami - Miami Project to Cure Paralysis
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Texas
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Dallas, Texas, Forenede Stater, 75246
- Rekruttering
- Baylor Scott & White Institute for Research
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Ledende efterforsker:
- Simon Driver, PhD
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Kontakt:
- Jacqueline Nguyen, MPH
- Telefonnummer: (469) 831-5321
- E-mail: Jacqueline.Nguyen@BSWHealth.org
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
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 undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Forebyggelse
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: 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. |
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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. |
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Change in Effectiveness of education modules as determined in the Knowledge Test
Tidsramme: baseline, up to 6 months
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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 |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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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
|
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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
|
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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.
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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.
|
Samarbejdspartnere og efterforskere
Sponsor
Samarbejdspartnere
Efterforskere
- Ledende efterforsker: Gary Farkas, PhD, University of Miami
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Anslået)
Studieafslutning (Anslået)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
- Sygdomme i centralnervesystemet
- Sygdomme i nervesystemet
- Sår og skader
- Ernæringsforstyrrelser
- Metaboliske sygdomme
- Overernæring
- Kropsvægt
- Glukosemetabolismeforstyrrelser
- Insulin resistens
- Hyperinsulinisme
- Overvægtig
- Traumer, nervesystemet
- Rygmarvssygdomme
- Patologiske tilstande, tegn og symptomer
- Ernæringsmæssige og metaboliske sygdomme
- Tegn og symptomer
- Fedme
- Metabolisk syndrom
- Rygmarvsskader
Andre undersøgelses-id-numre
- 20230202
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
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