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Educational Modules for Spinal Cord Injury

N/A

Recruiting

Led By Mark Nash, PhD

Research Sponsored by University of Miami

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

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

Must not have

Cognitive impairment that compromises the legitimacy of consent

Pregnancy determined by urine testing in sexually active females

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline, up to 6 months

Awards & highlights

No Placebo-Only Group

Summary

This trial tests if teaching people about heart & metabolic diseases helps them understand & improve their health.

Who is the study for?

This trial is for men and women aged 18-70 with spinal cord injury/disease (SCI/D), enrolled within 4 months after initial rehab. Participants should have complete or incomplete SCI at levels C5 and below, as per the ASIA Impairment Scale. It's not for prisoners, pregnant women, or those with cognitive impairments affecting consent.

What is being tested?

The study tests if education on cardiometabolic disease risks using PVA Consumer Guide and WebMD improves understanding of these risks in people with SCI/D. The goal is to see how this knowledge affects their health management.

What are the potential side effects?

Since the interventions are educational materials, there are no direct medical side effects expected from participating in this trial.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am between 18 and 70 years old with a spinal cord injury or disorder.

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My spinal cord injury is at level C5 or lower and is classified as ASIA A-D.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am able to understand and consent to the trial.

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I am not pregnant, as confirmed by a urine test.

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I have a severe skin injury from pressure when I joined the study.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, up to 6 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline, up to 6 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, up to 6 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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

Secondary study objectives

Change in Body Weight as determined by kilograms (kg)

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

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

+5 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Paralyzed Veterans of America (PVA) Cardio-Metabolic Disease (CMD) Consumer Guide GroupExperimental Treatment1 Intervention

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.

Group II: WebMD GroupActive Control1 Intervention

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.

0 / 5Eligibility criteria met