Spinal Cord Injury Model Systems (SCIMS) - Education Module

Study Overview
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Brief Summary
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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.

Official Title
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A Spinal Cord Injury (SCI) Stakeholder-vetted Education Module to Mitigate Early Cardioendocrine Health Risks Occurring After Spinal Cord Injuries.

Conditions
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Spinal Cord Injuries, Obesity, Cardiometabolic Syndrome

Intervention / Treatment
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* Behavioral: PVA Consumer Guide
* Behavioral: WebMD


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Paralyzed Veterans of America (PVA) Cardio-Metabolic Disease (CMD) Consumer Guide Group<br>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. | Behavioral: PVA Consumer Guide<br>* 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.<br>|
| Active Comparator: WebMD Group<br>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. | Behavioral: WebMD<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Effectiveness of education modules as determined in the Knowledge Test | 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Body Weight as determined by kilograms (kg) | Body weight will be measured in kilograms | baseline, up to 6 months | 
| Change in Body composition as determined by Dual X-ray Absorptiometry (DXA) | 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 | 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) | 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 | 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 | 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 | 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) | BP will be measured in mmHg using an arm cuff | baseline, up to 6 months. |