Education on cardiometabolic risks for spinal cord injury patients
A Spinal Cord Injury (SCI) Stakeholder-vetted Education Module to Mitigate Early Cardioendocrine Health Risks Occurring After Spinal Cord Injuries.
This study is testing if giving information about heart and metabolic health risks can help people with spinal cord injuries better understand and manage their health after rehab.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 250 (estimated) |
| Ages | 18 Years to 70 Years |
| Sex | All |
| Sponsor | University of Miami Academic / other |
| Locations | 3 sites (Washington D.C., District of Columbia and 2 other locations) |
| Trial ID | NCT06003686 on ClinicalTrials.gov |
What this trial studies
This study aims to evaluate whether providing education about the increased risks of cardiometabolic diseases can enhance understanding and management of these risks among individuals with spinal cord injuries. Participants will receive information through resources like the PVA Consumer Guide and WebMD. The focus is on individuals aged 18-70 with spinal cord injuries, specifically those with ASIA impairment scale levels A-D at C5 and below, who are enrolled shortly after rehabilitation discharge.
Who should consider this trial
Good fit: Ideal candidates are men and women aged 18-70 with spinal cord injuries who are neurologically complete or incomplete at levels C5 and below.
Not a fit: Patients who are pregnant, have cognitive impairments affecting consent, or have severe pressure injuries will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could improve health outcomes for spinal cord injury patients by increasing their awareness and management of cardiometabolic risks.
How similar studies have performed: Other studies have shown positive outcomes with educational interventions for managing health risks in similar patient populations.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Washington D.C., District of Columbia and 2 other locations
- MedStar National Rehabilitation Network — Washington D.C., District of Columbia, United States (Recruiting)
- University of Miami - Miami Project to Cure Paralysis — Miami, Florida, United States (Recruiting)
- Baylor Scott & White Institute for Research — Dallas, Texas, United States (Not_yet_recruiting)
Study contacts
- Principal investigator: Gary Farkas, PhD — University of Miami
- Study coordinator: Patricia Graham, MS
- Email: pgraham1@med.miami.edu
- Phone: 3052435119
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.