Spinal Cord InjuriesNCT06003686
Spinal Cord Injury Model Systems (SCIMS) - Education Module
A study testing PVA Consumer Guide and WebMD in people with Spinal Cord Injuries and Obesity, run by University of Miami at 3 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Spinal Cord Injuries, Obesity, Cardiometabolic Syndrome
- What is being tested?
- PVA Consumer Guide and WebMD
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 250 participants
- Where
- 3 sitesUnited States
- Study dates
- 5 Mar 2024to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States3 sites, 1 recruiting
- Recruiting
Baylor Scott & White Institute for Research
Dallas, Texas, 75246
Jacqueline Nguyen, MPH, (469) 831-5321, Jacqueline.Nguyen@BSWHealth.org
Simon Driver, PhD
- Active, not recruiting
University of Miami - Miami Project to Cure Paralysis
Miami, Florida, 33136
- Active, not recruiting
MedStar National Rehabilitation Network
Washington D.C., District of Columbia, 20010
About this study
Official title: A Spinal Cord Injury (SCI) Stakeholder-vetted Education Module to Mitigate Early Cardioendocrine Health Risks Occurring After Spinal Cord Injuries.
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
- Being tested
- PVA Consumer Guide, WebMD
- Medical subject headings
- Spinal Cord Injuries, Obesity, Metabolic Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PVA Consumer GuideBehavioural
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.
WebMDBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: WebMD |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: baseline, up to 6 months
Secondary outcomes (8)
Change in Body Weight as determined by kilograms (kg)
Body weight will be measured in kilograms
Measured: baseline, up to 6 months
Change in Body composition as determined by Dual X-ray Absorptiometry (DXA)
Body composition will be measured in grams using DXA
Measured: baseline, up to 6 months
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
Measured: baseline, up to 6 months
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
Measured: baseline, up to 6 months
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"
Measured: baseline, up to 6 months
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).
Measured: baseline, up to 6 months
Change in heart disease risk as determined by cholesterol
Risk of heart disease will be measured from a blood sample in mg/dL
Measured: baseline, up to 6 months.
Change in heart disease risk as determined by blood pressure (BP)
BP will be measured in mmHg using an arm cuff
Measured: baseline, up to 6 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2023
- Study start5 Mar 2024
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spinal Cord InjuriesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Miami
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Disability, Independent Living, and Rehabilitation Research
- Responsible party
- Principal investigator, Gary Farkas, University of Miami
- Investigators
- Gary Farkas, PhD, Principal investigator, University of Miami
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06003686
- Sponsor's protocol ID
- 20230202
- Status last verified
- Apr 2026
- First submitted
- 16 Aug 2023
- Last updated
- 30 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Spinal Cord Injury (SCI) Stakeholder-vetted Education Module to Mitigate Early Cardioendocrine Health Risks Occurring After Spinal Cord Injuries.
- ClinicalTrials.gov ID
- NCT06003686
- Acronym / sponsor ID
- 20230202
- Conditions
- Spinal Cord Injuries, Obesity, Cardiometabolic Syndrome
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- University of MiamiUniversity, hospital or other
- Collaborators
- National Institute on Disability, Independent Living, and Rehabilitation Research
- Study start
- 5 Mar 2024 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 22 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Paralyzed Veterans of America (PVA) Cardio-Metabolic Disease (CMD) Consumer Guide Group | Experimental | Behavioral: PVA Consumer GuideHard 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 | Active comparator | Behavioral: WebMDSubjects 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. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PVA Consumer GuideSubject'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. | Behavioural | Paralyzed Veterans of America (PVA) Cardio-Metabolic Disease (CMD) Consumer Guide Group |
| WebMDSubject'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. | Behavioural | WebMD Group |
Primary outcome
Change in Effectiveness of education modules as determined in the Knowledge Test
Time frame: 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.
8 secondary outcomes
Change in Body Weight as determined by kilograms (kg)
Time frame: baseline, up to 6 months
Change in Body composition as determined by Dual X-ray Absorptiometry (DXA)
Time frame: baseline, up to 6 months
Change in Body composition as determined by Dual X-ray Absorptiometry (DXA) in Percentage
Time frame: baseline, up to 6 months
Change in sugar metabolism as determined by Insulin resistance (IR)
Time frame: baseline, up to 6 months
Change in Quality of Life (QoL) as measured by Quality Index Spinal Cord Injury Version III
Time frame: baseline, up to 6 months
Change in Quality of Life (QoL) Using the International Spinal Cord Injury Basic Data Set
Time frame: baseline, up to 6 months
Change in heart disease risk as determined by cholesterol
Time frame: baseline, up to 6 months.
Change in heart disease risk as determined by blood pressure (BP)
Time frame: baseline, up to 6 months.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Sep 2026.
- Individual participant dataSharing planned: No
Related trials for Spinal Cord Injuries
Recruiting
Evaluating Long-term Use of a Pediatric Robotic Exoskeleton (P.REX/Agilik) to Improve Gait in Children With Movement Disorders
Cerebral Palsy, Muscular Dystrophy
Active, not recruitingObservational study
Nerve Transfer Surgery to Restore Upper-limb Function After Cervical Spinal Cord Injury
Spinal Cord Injury, Spinal Cord Injury at C5-C7 Level
Recruiting
Implementing a Decision Support Tool to Prevent Community-Acquired Pressure Injury in Spinal Cord Injury (SCI) in the Spinal Cord Injury Clinic
Spinal Cord Injury, Pressure Injury
Recruiting
Feasibility of the BrainGate2 Neural Interface System in Persons With Tetraplegia (BG-Tablet-01)
Brainstem Stroke, ALS
Recruiting
A Neuroprosthesis for Seated Posture and Balance
Spinal Cord Injury, Paralysis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Gary Farkas, PhD principal investigator
University of Miami
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PVA Consumer Guide and WebMD in people with Spinal Cord Injuries and Obesity, run by University of Miami at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 30 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Patricia Graham, MS (3052435119, pgraham1@med.miami.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Effectiveness of education modules as determined in the Knowledge Test (time frame: baseline, up to 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Sep 2026.