Educational Modules for Spinal Cord Injury

Recruiting at 5 trial locations

Overseen By Patricia Graham, MS

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Miami

Disqualifiers: Pregnancy, Cognitive impairment, Pressure injury, Prisoners

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

250 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if education about the risks of heart and metabolic diseases can help people with spinal cord injuries understand these risks and their impact on health. Participants will use either the PVA Consumer Guide or WebMD resources for learning. The trial suits individuals who have experienced a spinal cord injury at level C5 or below and have recently completed rehabilitation.

As an unphased trial, this study offers participants the chance to contribute to valuable research that could improve educational resources for spinal cord injury patients.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that these educational modules are safe for participants?

Research shows that the PVA Consumer Guide educates people about spinal cord injuries and related health issues. This guide relies on scientific research about these conditions. As it is purely informational and not a drug or medical device, using it as a learning tool poses no safety concerns.

Similarly, WebMD offers health information online. Like the PVA Consumer Guide, WebMD serves as an educational resource, so it presents no safety risks in this study. Both resources are well-known and widely used for health information, ensuring their safety for participants in this study. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores innovative educational tools for people with spinal cord injuries, focusing on improving their understanding of related health issues. Unlike traditional treatments that often focus on physical rehabilitation and pain management, this trial compares two unique educational resources: the WebMD platform and the Paralyzed Veterans of America (PVA) Cardio-Metabolic Disease Consumer Guide. The WebMD platform offers easy online access to a wide range of health information, while the PVA guide provides a tailored approach with both hard copy and electronic formats, specifically addressing cardio-metabolic health in veterans. By examining these tools, researchers hope to enhance patient education and empower individuals to better manage their health.

What evidence suggests that this trial's educational modules could be effective for understanding cardiometabolic disease risks in spinal cord injury patients?

Research has shown that educational materials can help people better understand health risks. In this trial, researchers will divide participants into two groups to evaluate different educational resources. One group will receive the PVA Consumer Guide, which offers clear information based on scientific research about spinal cord injuries and related risks. This guide is designed to help individuals understand possible outcomes and manage their health. The other group will be introduced to WebMD, a popular website that provides health information to the public, aiming to give users trustworthy details for informed health choices. Both resources aim to improve understanding of the health risks linked to spinal cord injuries, empowering individuals to take proactive steps for their well-being. ^{1 2 3 6 7}

Who Is on the Research Team?

Gary Farkas, PhD

Principal Investigator

University of Miami

Are You a Good Fit for This Trial?

This trial is for men and women aged 18-70 with spinal cord injury/disease (SCI/D), enrolled within 4 months after initial rehab. Participants should have complete or incomplete SCI at levels C5 and below, as per the ASIA Impairment Scale. It's not for prisoners, pregnant women, or those with cognitive impairments affecting consent.

Inclusion Criteria

My spinal cord injury is at level C5 or lower and is classified as ASIA A-D.

Enrolled no later than 4 months following discharge from initial rehabilitation from SCI

Exclusion Criteria

I am able to understand and consent to the trial.

I am not pregnant, as confirmed by a urine test.

Prisoners

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Education

Participants receive education regarding increased risks of cardiometabolic disease to understand these risks and their impact on health

6 months

Regular sessions (in-person or virtual)

Follow-up

Participants are monitored for changes in knowledge, heart disease risk, sugar metabolism, quality of life, body weight, and body composition

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• PVA Consumer Guide
• WebMD

Trial Overview The study tests if education on cardiometabolic disease risks using PVA Consumer Guide and WebMD improves understanding of these risks in people with SCI/D. The goal is to see how this knowledge affects their health management.

How Is the Trial Designed?

Group I: Paralyzed Veterans of America (PVA) Cardio-Metabolic Disease (CMD) Consumer Guide Group Experimental Treatment 1 Intervention

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.

Group II: WebMD Group Active Control 1 Intervention

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.

Who Is Running the Clinical Trial?

University of Miami

Lead Sponsor

Trials

976

Recruited

423,000+

National Institute on Disability, Independent Living, and Rehabilitation Research

Collaborator

Trials

83

Recruited

10,500+

Published Research Related to This Trial

The self-directed learning module provides updated information on spinal cord injury rehabilitation, focusing on initial care, injury classification, and prevention of complications.

Recent research advancements discussed in the module aim to enhance and restore neurological function in patients with spinal cord injuries, highlighting the potential for improved rehabilitation outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Spinal cord injury rehabilitation. 1. Assessment and management during acute care. Yarkony, GM., Formal, CS., Cawley, MF.[2019]

A readability analysis of 104 sections from 10 reputable websites revealed that the average Flesch-Kincaid Grade Level was 11.9, indicating that the materials are written at a level too advanced for most Americans to understand.

The Flesch Reading Ease score of 40.2 suggests that the language used in these online patient education resources is complex, highlighting the need for revisions to improve accessibility and comprehension for patients with spinal cord injuries.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Quality Assessment of Spinal Cord Injury Patient Education Resources. Agarwal, N., Hansberry, DR., Singh, PL., et al.[2019]

The module emphasizes the importance of understanding the multisystem effects of spinal cord injury (SCI) on patients, focusing on their adjustment, autonomy, and quality of life.

It highlights the role of interdisciplinary, person-centered rehabilitation in enhancing patients' experiences and success in their chosen life roles after SCI.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Spinal cord injury rehabilitation. 4. Individual experience, personal adaptation, and social perspectives. Stiens, SA., Bergman, SB., Formal, CS.[2019]

An online patient education resource for spinal cord injury rehabilitation was developed with input from over 100 experts and preliminary evaluation by 25 end-users, ensuring the content was relevant and effective.

The development process involved iterative feedback and collaboration, resulting in five comprehensive courses with over 45 minutes of video content each, which users found satisfying and effective for their learning.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

SCI-U: e-learning for patient education in spinal cord injury rehabilitation. Shepherd, JD., Badger-Brown, KM., Legassic, MS., et al.[2021]

Patients with acute spinal cord injuries reported significant issues with the content of information provided about their rights and discharge instructions, with satisfaction improving only slightly after staff communication training.

While patients' functional independence improved by discharge, levels of anxiety and depression remained high, indicating a need for ongoing mental health support in this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Acute spinal cord injury patients' satisfaction with care: Results from an intervention study in a specialized rehabilitation unit. Lusilla-Palacios, P., Castellano-Tejedor, C.[2018]

The self-directed learning module focuses on the latest advancements in spinal cord injury rehabilitation, addressing the multifaceted challenges—medical, psychological, and social—that individuals face after such injuries.

It emphasizes the evolving nature of these challenges throughout a person's life, highlighting the importance of continuous education for practitioners and trainees in physical medicine and rehabilitation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Spinal cord injury rehabilitation. 5. Through the lifespan. Cawley, MF., Yarkony, GM., Bergman, SB.[2019]

A survey of 123 spinal cord injury physicians revealed that 92% manage pain for patients with spinal cord damage, with 82% considering opioids appropriate for uncontrolled acute pain, but only 67% for chronic pain.

Many physicians (46%) believe there should be no upper limit on opioid doses if tolerated, which contradicts current guidelines, and most would continue prescribing high doses if effective, indicating a need for better alignment with safety recommendations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pulse article: opioid prescription for pain after spinal cord damage (SCD), differences from recommended guidelines, and a proposed algorithm for the use of opioids for pain after SCD. Wong, TK., Alexander, MS., New, PW., et al.[2023]

The PAR-QoL toolkit, designed to help assess quality of life in individuals with spinal cord injury, had 188,577 users, but only 46 survey respondents indicated limited current use, suggesting a need for better engagement.

To improve usability and increase uptake, recommendations include enhancing website navigation, removing less useful components, regularly updating content, and promoting the toolkit more effectively.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Usability of the Participation and Quality of Life (PAR-QoL) Outcomes Toolkit Website for Spinal Cord Injury. Beaudoin, M., Best, KL., Routhier, F., et al.[2021]

Citations

1. pva.org pva.org/wp-content/uploads/2021/09/cpg_outcomes-following-traumatic-sci.pdf

Outcomes Following Traumatic Spinal Cord Injury This guide has been prepared based on scientific and professional information known about outcomes following traumatic spinal cord injury and its treatment in ...

2. pva.org pva.org/research-resources/publications/consumer-guides/

Consumer Guides - Paralyzed Veterans Of America Preservation of Upper Limb Function Following Spinal Cord Injury: What You Should Know. Download PDF. Pressure Ulcers: What You Should Know. Download PDF ...

3. asia-spinalinjury.org asia-spinalinjury.org/wp-content/uploads/2024/05/5_3_2024-ASIA-presentation-Cheryl-Vines.pdf

Paralyzed Veterans of America The Mission of the PVA Research Foundation is: • To promote innovative research to find better treatments and cures for paralysis.

4. pvanewengland.org pvanewengland.org/sci-d-resources/publications/

Publications About Spinal Cord Injuries & Diseases New England PVA has a wide variety of publications about spinal cord injuries and diseases, plus advocacy, accessibility, consumer guides and more.

5. pva.org pva.org/wp-content/uploads/2021/09/consumer-guide_outcomes_oc13.pdf

SPINAL CORD MEDICINE - C1-3 - Expected Outcomes This consumer guide is based on the clinical practice guideline about outcomes following traumatic SCI currently available for health-care profession- als. Tell ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT06003686

NCT06003686 | Spinal Cord Injury Model Systems (SCIMS) Also called a data safety and monitoring board, or DSMB. ... Subject's will receive education on the PVA consumer guide 3 times over the course of the study.

7. christopherreeve.org christopherreeve.org/wp-content/uploads/2024/03/Spinal-Cord-Injury-QA-2-24-A.pdf

Spinal Cord Injury The site has over. 1,000 videos drawn from personal interviews with people who live with spinal cord injuries and their caregivers and families as well as ...