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NCT Number: NCT06003686

Spinal Cord Injury Model Systems (SCIMS) - Education Module

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.

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Key information

Conditions

Spinal Cord Injuries Body Weight Cardiometabolic Syndrome Central Nervous System Diseases Glucose Metabolism Disorders Hyperinsulinism Insulin Resistance Metabolic Diseases Metabolic Syndrome Nervous System Diseases Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms Spinal Cord Diseases Trauma, Nervous System Wounds and Injuries

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

MedStar National Rehabilitation Network, Washington D.C., District of Columbia, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

PVA Consumer Guide

Behavioral

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.

WebMD

Behavioral

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.

Primary outcomes

  1. Change in Effectiveness of education modules as determined in the Knowledge Test

    Time frame: 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.

Secondary outcomes

  1. Change in Body Weight as determined by kilograms (kg)

    Time frame: baseline, up to 6 months

    Body weight will be measured in kilograms

  2. Change in Body composition as determined by Dual X-ray Absorptiometry (DXA)

    Time frame: baseline, up to 6 months

    Body composition will be measured in grams using DXA

  3. Change in Body composition as determined by Dual X-ray Absorptiometry (DXA) in Percentage

    Time frame: baseline, up to 6 months

    Body composition will be expressed as a percentage of body fat (BF) using DXA

  4. Change in sugar metabolism as determined by Insulin resistance (IR)

    Time frame: 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

  5. Change in Quality of Life (QoL) as measured by Quality Index Spinal Cord Injury Version III

    Time frame: 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"

  6. Change in Quality of Life (QoL) Using the International Spinal Cord Injury Basic Data Set

    Time frame: baseline, up to 6 months

    QoL values will be determined using a scale ranging from 0 (completely dissatisfied) to 10 (completely satisfied).

  7. Change in heart disease risk as determined by cholesterol

    Time frame: baseline, up to 6 months.

    Risk of heart disease will be measured from a blood sample in mg/dL

  8. Change in heart disease risk as determined by blood pressure (BP)

    Time frame: baseline, up to 6 months.

    BP will be measured in mmHg using an arm cuff

Study contacts

Contact information is provided by the study sponsor or research team.

Patricia Graham, MS

CONTACT

[email protected]

3052435119

Sponsors and collaborators

Lead sponsor

University of Miami

Other

Collaborators

  • National Institute on Disability, Independent Living, and Rehabilitation Research

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Aug 22, 2023
Registry last updated
Apr 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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