Spinal Cord Injury Model Systems (SCIMS) - Education Module

April 16, 2026 updated by: Gary Farkas, University of Miami

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

250

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • District of Columbia
      • Washington D.C., District of Columbia, United States, 20010
        • Recruiting
        • MedStar National Rehabilitation Network
        • Principal Investigator:
          • Suzanne Groah, MD
        • Contact:
    • Florida
      • Miami, Florida, United States, 33136
        • Recruiting
        • University of Miami - Miami Project to Cure Paralysis
        • Contact:
        • Contact:
        • Principal Investigator:
          • Gary J Farkas, PhD
    • Texas
      • Dallas, Texas, United States, 75246
        • Not yet recruiting
        • Baylor Scott & White Institute for Research
        • Principal Investigator:
          • Simon Driver, PhD
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Men and Women with SCI/D aged 18-70 years.
  2. Neurologically complete and incomplete American Spinal Injury Association (ASIA) Impairment scale (AIS) A-D spinal cord levels C5 and below.
  3. Enrolled no later than 4 months following discharge from initial rehabilitation from SCI.

Exclusion Criteria:

  1. Pregnancy determined by urine testing in sexually active females.
  2. Cognitive impairment that compromises the legitimacy of consent.
  3. Grade 3-4 pressure injury at the time of study entry.
  4. Prisoners

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional 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
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

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.
Active Comparator: 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.
Behavioral: WebMD
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
baseline, up to 6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Body Weight as determined by kilograms (kg)
Time Frame: 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)
Time Frame: 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
Time Frame: 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)
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
baseline, up to 6 months
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"
baseline, up to 6 months
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).
baseline, up to 6 months
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
baseline, up to 6 months.
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
baseline, up to 6 months.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Miami

Collaborators

National Institute on Disability, Independent Living, and Rehabilitation Research

Investigators

  • Principal Investigator: Gary Farkas, PhD, University of Miami

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 5, 2024

Primary Completion (Estimated)

October 31, 2026

Study Completion (Estimated)

October 31, 2026

Study Registration Dates

First Submitted

August 16, 2023

First Submitted That Met QC Criteria

August 16, 2023

First Posted (Actual)

August 22, 2023

Study Record Updates

Last Update Posted (Actual)

April 20, 2026

Last Update Submitted That Met QC Criteria

April 16, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20230202

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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