Spinal Cord Injury Model Systems (SCIMS) - Education Module

NCT06003686 | Recruiting

• 1 other identifier: 20230202
• Study Type: interventional
• Target: 250
• Locations: 1 country
• Sites: 3

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.

Conditions

Spinal Cord Injuries; Obesity; Cardiometabolic Syndrome

Outcome Measures

Primary Outcomes (1)

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

  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 Outcomes (8)

• Change in Body Weight as determined by kilograms (kg)

  baseline, up to 6 months

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

  baseline, up to 6 months

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

  baseline, up to 6 months

• Change in sugar metabolism as determined by Insulin resistance (IR)

  baseline, up to 6 months

• Change in Quality of Life (QoL) as measured by Quality Index Spinal Cord Injury Version III

  baseline, up to 6 months

Study Arms (2)

Paralyzed Veterans of America (PVA) Cardio-Metabolic Disease (CMD) Consumer Guide Group

EXPERIMENTAL

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

WebMD Group

ACTIVE COMPARATOR

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

Interventions

PVA Consumer Guide BEHAVIORAL

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.

Paralyzed Veterans of America (PVA) Cardio-Metabolic Disease (CMD) Consumer Guide Group

WebMD BEHAVIORAL

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.

WebMD Group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Miami: lead
• National Institute on Disability, Independent Living, and Rehabilitation Research: collaborator

Study Sites (3)

MedStar National Rehabilitation Network

Washington D.C., District of Columbia, 20010, United States

RECRUITING

University of Miami - Miami Project to Cure Paralysis

Miami, Florida, 33136, United States

RECRUITING

Baylor Scott & White Institute for Research

Dallas, Texas, 75246, United States

NOT YET RECRUITING

MeSH Terms

Conditions

Spinal Cord Injuries; Obesity; Metabolic Syndrome

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Insulin Resistance; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases

Study Officials

• Gary Farkas, PhD

  University of Miami

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Patricia Graham, MS

CONTACT

3052435119; pgraham1@med.miami.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 16, 2023
• First Posted: August 22, 2023
• Study Start: March 5, 2024
• Primary Completion (Estimated): October 31, 2026
• Study Completion (Estimated): October 31, 2026
• Last Updated: April 20, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)