Spinal Cord Injury Model Systems (SCIMS) - Education Module

Not Applicable

Recruiting

• Conditions: Spinal Cord Injuries; Cardiometabolic Syndrome; Obesity
• Interventions: Behavioral: PVA Consumer Guide; Behavioral: WebMD

• Registration Number: NCT06003686
• Lead Sponsor: University of Miami

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-08-16
• Study First Submitted QC: 2023-08-16
• Study First Posted: 2023-08-22
• Study Start: 2024-03-05
• Status Verified: 2025-03
• Last Update Submitted: 2025-04-19
• Last Update Posted: 2025-04-24
• Primary Completion: 2025-10-31
• Study Completion: 2026-10-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 250

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Paralyzed Veterans of America (PVA) Cardio-Metabolic Disease (CMD) Consumer Guide Group	PVA Consumer Guide	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.
WebMD Group	WebMD	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.

Primary Outcome Measures

Name	Time	Method
Change in Effectiveness of education modules as determined in the Knowledge Test	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 Outcome Measures

Name	Time	Method
Change in Body Weight as determined by kilograms (kg)	baseline, up to 6 months	Body weight will be measured in kilograms
Change in Quality of Life (QoL) Using the International Spinal Cord Injury Basic Data Set	baseline, up to 6 months	QoL values will be determined using a scale ranging from 0 (completely dissatisfied) to 10 (completely satisfied).
Change in Quality of Life (QoL) as measured by Quality Index Spinal Cord Injury Version III	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"
Change in heart disease risk as determined by blood pressure (BP)	baseline, up to 6 months.	BP will be measured in mmHg using an arm cuff
Change in sugar metabolism as determined by Insulin resistance (IR)	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
Change in Body composition as determined by Dual X-ray Absorptiometry (DXA)	baseline, up to 6 months	Body composition will be measured in grams using DXA
Change in Body composition as determined by Dual X-ray Absorptiometry (DXA) in Percentage	baseline, up to 6 months	Body composition will be expressed as a percentage of body fat (BF) using DXA
Change in heart disease risk as determined by cholesterol	baseline, up to 6 months.	Risk of heart disease will be measured from a blood sample in mg/dL

Trial Locations

Locations (3)

MedStar National Rehabilitation Network; 🇺🇸 Washington, District of Columbia, United States

University of Miami - Miami Project to Cure Paralysis; 🇺🇸 Miami, Florida, United States

Baylor Scott & White Institute for Research; 🇺🇸 Dallas, Texas, United States