Educational Modules for Spinal Cord Injury

Recruiting at 4 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?

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.

Will I have to stop taking my current medications?

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

How is the 'Educational Modules for Spinal Cord Injury' treatment different from other treatments for spinal cord injury?

This treatment is unique because it focuses on providing educational resources to help patients understand and manage their spinal cord injury, rather than directly addressing the physical aspects of the condition. It aims to empower patients through knowledge, which can complement other medical and rehabilitation therapies. ^{1 2 3 4 5}

What data supports the effectiveness of the treatment PVA Consumer Guide, WebMD, WebMD General Health Application for spinal cord injury?

The research highlights the importance of patient education and quality of life in spinal cord injury rehabilitation, suggesting that educational resources like the PVA Consumer Guide and WebMD can be valuable. While specific effectiveness data for these resources is not provided, similar educational tools have been shown to aid in patient adaptation and satisfaction with care. ^{2 3 6 7 8}

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

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]

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 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]

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]

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 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]

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]

Citations

1. England pubmed.ncbi.nlm.nih.gov

SCI-U: e-learning for patient education in spinal cord injury rehabilitation. [2021]

2. United States pubmed.ncbi.nlm.nih.gov

Quality Assessment of Spinal Cord Injury Patient Education Resources. [2019]

3. United States pubmed.ncbi.nlm.nih.gov

Usability of the Participation and Quality of Life (PAR-QoL) Outcomes Toolkit Website for Spinal Cord Injury. [2021]

4. United States pubmed.ncbi.nlm.nih.gov

Spinal cord injury rehabilitation. 4. Individual experience, personal adaptation, and social perspectives. [2019]

5. England pubmed.ncbi.nlm.nih.gov

Acute spinal cord injury patients' satisfaction with care: Results from an intervention study in a specialized rehabilitation unit. [2018]

6. United States pubmed.ncbi.nlm.nih.gov

Spinal cord injury rehabilitation. 1. Assessment and management during acute care. [2019]

7. United States pubmed.ncbi.nlm.nih.gov

Spinal cord injury rehabilitation. 5. Through the lifespan. [2019]

8. England 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. [2023]