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Spinal Cord Injury Model Systems (SCIMS) - Education Module

Primary Purpose

Spinal Cord Injuries, Obesity, Cardiometabolic Syndrome

Status
Not yet recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
PVA Consumer Guide
WebMD
Sponsored by
University of Miami
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Spinal Cord Injuries

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: 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. Exclusion Criteria: 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

Sites / Locations

  • MedStar National Rehabilitation Network
  • University of Miami - Miami Project to Cure Paralysis
  • University of Minnesota Rehabilitation
  • Baylor Scott & White Institute for Research
  • McGuire Research Institute Richmond VA Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

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

WebMD Group

Arm 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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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

Full Information

First Posted
August 16, 2023
Last Updated
October 18, 2023
Sponsor
University of Miami
Collaborators
National Institute on Disability, Independent Living, and Rehabilitation Research
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1. Study Identification

Unique Protocol Identification Number
NCT06003686
Brief Title
Spinal Cord Injury Model Systems (SCIMS) - Education Module
Official Title
A Spinal Cord Injury (SCI) Stakeholder-vetted Education Module to Mitigate Early Cardioendocrine Health Risks Occurring After Spinal Cord Injuries.
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
December 31, 2023 (Anticipated)
Primary Completion Date
October 31, 2025 (Anticipated)
Study Completion Date
October 31, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Miami
Collaborators
National Institute on Disability, Independent Living, and Rehabilitation Research

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Spinal Cord Injuries, Obesity, Cardiometabolic Syndrome

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
250 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Paralyzed Veterans of America (PVA) Cardio-Metabolic Disease (CMD) Consumer Guide Group
Arm Type
Experimental
Arm 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.
Arm Title
WebMD Group
Arm Type
Active Comparator
Arm 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.
Intervention Type
Behavioral
Intervention Name(s)
PVA Consumer Guide
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
WebMD
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in Effectiveness of education modules as determined in the Knowledge Test
Description
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.
Time Frame
baseline, up to 6 months
Secondary Outcome Measure Information:
Title
Change in Body Weight as determined by kilograms (kg)
Description
Body weight will be measured in kilograms
Time Frame
baseline, up to 6 months
Title
Change in Body composition as determined by Dual X-ray Absorptiometry (DXA)
Description
Body composition will be measured in grams using DXA
Time Frame
baseline, up to 6 months
Title
Change in Body composition as determined by Dual X-ray Absorptiometry (DXA) in Percentage
Description
Body composition will be expressed as a percentage of body fat (BF) using DXA
Time Frame
baseline, up to 6 months
Title
Change in sugar metabolism as determined by Insulin resistance (IR)
Description
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
Time Frame
baseline, up to 6 months
Title
Change in Quality of Life (QoL) as measured by Quality Index Spinal Cord Injury Version III
Description
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"
Time Frame
baseline, up to 6 months
Title
Change in Quality of Life (QoL) Using the International Spinal Cord Injury Basic Data Set
Description
QoL values will be determined using a scale ranging from 0 (completely dissatisfied) to 10 (completely satisfied).
Time Frame
baseline, up to 6 months
Title
Change in heart disease risk as determined by cholesterol
Description
Risk of heart disease will be measured from a blood sample in mg/dL
Time Frame
baseline, up to 6 months.
Title
Change in heart disease risk as determined by blood pressure (BP)
Description
BP will be measured in mmHg using an arm cuff
Time Frame
baseline, up to 6 months.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Patricia Graham, MS
Phone
3052435119
Email
pgraham1@med.miami.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mark Nash, PhD
Organizational Affiliation
University of Miami
Official's Role
Principal Investigator
Facility Information:
Facility Name
MedStar National Rehabilitation Network
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20010
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ana Aguirre
Phone
202-877-1875
Email
AnaValeria.AguirreGuemez@medstar.net
First Name & Middle Initial & Last Name & Degree
Suzanne Groah, MD
Facility Name
University of Miami - Miami Project to Cure Paralysis
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
Facility Name
University of Minnesota Rehabilitation
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55455
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Carmen Terzic, MD
Phone
507-538-1580
Email
terzic.carmen@mayo.edu
First Name & Middle Initial & Last Name & Degree
Leslie Morse, MD
Facility Name
Baylor Scott & White Institute for Research
City
Dallas
State/Province
Texas
ZIP/Postal Code
75246
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jacqueline Nguyen, MPH
Phone
469-831-5321
Email
Jacqueline.Nguyen@BSWHealth.org
First Name & Middle Initial & Last Name & Degree
Simon Driver, PhD
Facility Name
McGuire Research Institute Richmond VA Medical Center
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23284-0667
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Refka Khalil
Email
refka.khalil@va.gov
First Name & Middle Initial & Last Name & Degree
Ashraf Gorgey, MD

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Spinal Cord Injury Model Systems (SCIMS) - Education Module

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