Spinal Cord Injury Model Systems (SCIMS) - Education Module

University of Miami

Status: Enrolling

Conditions: Spinal Cord Injuries; Cardiometabolic Syndrome; Obesity

Treatments: Behavioral: WebMD; Behavioral: PVA Consumer Guide

Study type: Interventional

Funder types: Other; Other U.S. Federal agency

Identifiers

NCT06003686

20230202

Details and patient eligibility

About

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.

Enrollment: 250 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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250 participants in 2 patient groups

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

Experimental group

Description:

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.

Treatment:

Behavioral: PVA Consumer Guide

WebMD Group

Active Comparator group

Description:

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.

Treatment:

Behavioral: WebMD