Spinal Cord Injury Model Systems (SCIMS) - Utbildningsmodul
En ryggmärgsskada (SCI) Intressentbevakad utbildningsmodul för att mildra tidiga kardioendokrina hälsorisker som uppstår efter ryggmärgsskador.
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.
Studieöversikt
Status
Betingelser
Intervention / Behandling
Studietyp
Inskrivning (Beräknad)
Fas
- Inte tillämpbar
Kontakter och platser
Studiekontakt
- Namn: Patricia Graham, MS
- Telefonnummer: 3052435119
- E-post: pgraham1@med.miami.edu
Studieorter
-
-
District of Columbia
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Washington D.C., District of Columbia, Förenta staterna, 20010
- Aktiv, inte rekryterande
- MedStar National Rehabilitation Network
-
-
Florida
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Miami, Florida, Förenta staterna, 33136
- Aktiv, inte rekryterande
- University of Miami - Miami Project to Cure Paralysis
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-
Texas
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Dallas, Texas, Förenta staterna, 75246
- Rekrytering
- Baylor Scott & White Institute for Research
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Huvudutredare:
- Simon Driver, PhD
-
Kontakt:
- Jacqueline Nguyen, MPH
- Telefonnummer: (469) 831-5321
- E-post: Jacqueline.Nguyen@BSWHealth.org
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
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
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Förebyggande
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Experimentell: 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. |
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Change in Effectiveness of education modules as determined in the Knowledge Test
Tidsram: 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
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Change in Body Weight as determined by kilograms (kg)
Tidsram: 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)
Tidsram: 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
Tidsram: 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)
Tidsram: 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
Tidsram: 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
Tidsram: 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
|
|
Change in heart disease risk as determined by cholesterol
Tidsram: baseline, up to 6 months.
|
Risk of heart disease will be measured from a blood sample in mg/dL |
baseline, up to 6 months.
|
|
Change in heart disease risk as determined by blood pressure (BP)
Tidsram: baseline, up to 6 months.
|
BP will be measured in mmHg using an arm cuff |
baseline, up to 6 months.
|
Samarbetspartners och utredare
Sponsor
Utredare
- Huvudutredare: Gary Farkas, PhD, University of Miami
Studieavstämningsdatum
Studera stora datum
Studiestart (Faktisk)
Primärt slutförande (Beräknad)
Avslutad studie (Beräknad)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
- Sjukdomar i centrala nervsystemet
- Sjukdomar i nervsystemet
- Sår och skador
- Näringsstörningar
- Metaboliska sjukdomar
- Övernäring
- Kroppsvikt
- Störningar i glukosmetabolism
- Insulinresistens
- Hyperinsulinism
- Övervikt
- Trauma, nervsystemet
- Ryggmärgssjukdomar
- Patologiska tillstånd, tecken och symtom
- Närings- och metabola sjukdomar
- Tecken och symtom
- Fetma
- Metaboliskt syndrom
- Ryggmärgsskador
Andra studie-ID-nummer
- 20230202
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
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