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Recruiting NCT06003686

Spinal Cord Injury Model Systems (SCIMS) - Education Module

No phase Interventional Spinal Cord Injuries Obesity Cardiometabolic Syndrome

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: PVA Consumer Guide, WebMD.
Who it may be relevant to
Registry conditions: Spinal Cord Injuries, Obesity, Cardiometabolic Syndrome. Basic parameters: 18 years — 70 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Interventions

  • 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.
  • 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

Primary outcome measures

  • Change in Effectiveness of education modules as determined in the Knowledge Test [Time frame: baseline, up to 6 months]
Secondary outcome measures (8)
  • Change in Body Weight as determined by kilograms (kg) [Time frame: baseline, up to 6 months]
  • Change in Body composition as determined by Dual X-ray Absorptiometry (DXA) [Time frame: 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]
  • Change in sugar metabolism as determined by Insulin resistance (IR) [Time frame: 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]
  • Change in Quality of Life (QoL) Using the International Spinal Cord Injury Basic Data Set [Time frame: baseline, up to 6 months]
  • Change in heart disease risk as determined by cholesterol [Time frame: baseline, up to 6 months.]
  • Change in heart disease risk as determined by blood pressure (BP) [Time frame: baseline, up to 6 months.]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Prevention

Study locations

United States · 3 centers
  • MedStar National Rehabilitation Network — Washington D.C.
  • University of Miami - Miami Project to Cure Paralysis — Miami
  • Baylor Scott & White Institute for Research — Dallas

Identifiers

NCT: NCT06003686 · 20230202

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗