Self-Management Program for Spinal Cord Injury

(SCISM-D Trial)

Overseen By Scott D McDonald, PhD

Age: Any Age

Sex: Any

Trial Phase: Phase 1 & 2

Sponsor: VA Office of Research and Development

Disqualifiers: Psychotic disorder, Suicidal risk, Substance dependence, others

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

Compensation: Varies

Number of Visits: 5

9 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but if you have mental disorders like PTSD or depression, your medications must be stable for at least 30 days before joining.

What data supports the effectiveness of the treatment SCI Self-Management for AIS D?

Research shows that self-management programs for spinal cord injury often include components like symptom management, information about the condition, and coping strategies, which are linked to reduced health complications and improved quality of life. These programs are still being refined, but they show promise in helping individuals manage their condition more effectively. ^{1 2 3 4 5}

Is the Self-Management Program for Spinal Cord Injury safe for humans?

The available research does not provide specific safety data for the Self-Management Program for Spinal Cord Injury, but it suggests that self-management programs can help reduce complications in people with spinal cord injuries. There is no mention of any safety concerns related to these programs. ^{6 7 8 9 10}

How is the SCI Self-Management Program for AIS D different from other treatments for spinal cord injury?

The SCI Self-Management Program for AIS D is unique because it focuses on empowering individuals with spinal cord injury to manage their own health through personalized strategies, peer support, and web-based resources, which are not typically emphasized in traditional rehabilitation programs. ^{1 3 4 10 11}

What is the purpose of this trial?

About 25-51% of adults with acquired spinal cord injury (SCI) have "AIS D" SCI, the lowest severity grade of neurologic injury. Veterans with AIS D SCI generally have better outcomes in mobility, community integration, and employment. However, counterintuitively, they are also at higher risk of poor subjective well-being (SWB) and related psychosocial outcomes. Preliminary evidence suggests that poorer SWB in this group is associated with distinctive, modifiable factors such as less intensity of acute rehabilitation services, limited development of instrumental and social support networks, and underdeveloped disability identity. A significant gap in the care of Veterans with AIS D SCI is that they are unlikely to receive rehabilitation that is responsive to their specific experiences and needs. The proposed study will develop a novel, self-management based program to help Veterans with AIS D SCI. This study is highly significant, as creation of the proposed program is expected to improve SWB and lifetime psychosocial functioning for Veterans with AIS D SCI.

Research Team

Scott D McDonald, PhD

Principal Investigator

Hunter Holmes McGuire VA Medical Center, Richmond, VA

Eligibility Criteria

This trial is for Veterans with a specific spinal cord injury called AIS D, which has the lowest severity. Participants must be able to join focus groups via video telehealth and not be in an intensive rehab program or have conditions like psychosis, active substance dependence, or risk of self-harm.

Inclusion Criteria

VA clinician-confirmed diagnosis of tetraplegia or paraplegia with an ASIA rating of AIS D [Veterans with AIS D SCI]

Interest and ability (e.g., reliable video telehealth equipment and WiFi) to participate in the focus groups.

Exclusion Criteria

I do not have any conditions like advanced cancer or Parkinson's that could affect the study results.

Active substance dependence

My mental health medication has been stable for over 30 days.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Development

Development of the SCISM-D program through focus groups and expert feedback

4-8 weeks

Multiple focus group meetings

Pilot Study

Pilot study to test feasibility and acceptability of SCISM-D with 5-7 sessions

6 weeks

5-7 sessions (telehealth)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• SCI Self-Management for AIS D

Trial Overview The study is developing a new self-management program tailored for Veterans with AIS D SCI. It aims to improve their subjective well-being by addressing unique challenges such as social support networks and disability identity.

Participant Groups

Group I: Treatment Experimental Treatment 1 Intervention

Receives SCISM-D.

Who Is Running the Clinical Trial?

VA Office of Research and Development

Lead Sponsor

Trials

1,691

Recruited

3,759,000+

Findings from Research

A scoping review of 112 studies identified 102 unique self-management programs for spinal cord injury (SCI), with most programs focusing on individual approaches and emphasizing symptom management, condition information, and coping strategies.

The review highlights that self-management interventions for SCI are still in early development stages, indicating a need for further refinement and testing to improve their effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Scoping Review of Self-Management Interventions Following Spinal Cord Injury. McIntyre, A., Marrocco, SL., McRae, SA., et al.[2021]

In a study of 73 patients with incomplete cervical spinal cord injury classified as AIS C, older age and impairment in anorectal examination were identified as significant risk factors for remaining non-ambulatory after one year.

The research highlights that specific neurological assessments, such as the S4-5 sensory score and anal reflexes, can help predict which patients may struggle with mobility, emphasizing the importance of early evaluation in treatment planning.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Risk factors of AIS C incomplete cervical spinal cord injury for poor prognosis-The significance of anorectal evaluation. Tsuji, O., Suda, K., Michikawa, T., et al.[2023]

The study emphasizes the importance of integrating self-management into rehabilitation for adults with spinal cord injury or disease (SCI/D), highlighting that trained staff can significantly improve patient outcomes.

Key indicators for successful self-management include ensuring staff education on self-management principles, conducting timely assessments for patients, and measuring skill acquisition, which together can empower individuals with SCI/D to better manage their health and enhance their quality of life.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Conception and development of Self-Management indicators to advance the quality of spinal cord injury rehabilitation: SCI-High Project. Jeyathevan, G., Jaglal, SB., Hitzig, SL., et al.[2022]

In a study involving 48 patients with spinal cord injury (SCI) across three Dutch rehabilitation centers, therapists recorded 1640 treatment sessions over four weeks, focusing on interventions to improve self-care and mobility.

The most common interventions included improving muscle power, walking, and hand rim wheelchair propulsion, indicating a strong emphasis on enhancing physical capabilities in early post-acute rehabilitation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Contents of physical therapy, occupational therapy, and sports therapy sessions for patients with a spinal cord injury in three Dutch rehabilitation centres. van Langeveld, SA., Post, MW., van Asbeck, FW., et al.[2011]

A survey of 99 individuals with traumatic spinal cord injury revealed that 74.7% rated the development of a self-management program as 'very important' or 'important', highlighting the need for such initiatives to empower individuals in managing their health.

Key components of the self-management program identified by participants included exercise, nutrition, and pain management, with a preference for internet-based delivery and peer support from individuals with similar injury levels.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Views of people with traumatic spinal cord injury about the components of self-management programs and program delivery: a Canadian pilot study. Munce, SE., Fehlings, MG., Straus, SE., et al.[2021]

The study highlights potential issues with the American Spinal Injury Association (AIS) classification system, particularly in cases where expected neurological recovery does not align with AIS grade changes, suggesting that the system may not fully capture the complexities of spinal cord injury recovery.

The authors observed instances where patients showed neurological improvements without corresponding changes in AIS grades, indicating a limitation of the AIS system that warrants further analysis of existing spinal cord injury data to better understand these discrepancies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Can spinal cord injury patients show a worsening in ASIA impairment scale classification despite actually having neurological improvement? The limitation of ASIA Impairment Scale Classification. Gündoğdu, İ., Akyüz, M., Öztürk, EA., et al.[2014]

In a study of 444 adults with traumatic spinal cord injury, 79.3% experienced adverse events, with urinary tract infections and pneumonia being the most common, highlighting the high risk of complications in this patient group.

Older age and more severe injuries were linked to increased adverse events, while certain modifiable comorbidities, like substance use and psychiatric conditions, were associated with specific risks such as delirium and pneumonia, suggesting that addressing these factors could help reduce complications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Previously Identified Common Post-Injury Adverse Events in Traumatic Spinal Cord Injury-Validation of Existing Literature and Relation to Selected Potentially Modifiable Comorbidities: A Prospective Canadian Cohort Study. Marion, TE., Rivers, CS., Kurban, D., et al.[2019]

In a study of 171 patients with traumatic spinal cord injury (TSCI), over 77% experienced adverse events (AEs) during acute hospital care, with urinary tract infections and pneumonias being the most common, highlighting the need for improved monitoring and prevention strategies.

The presence of certain AEs, such as decubitus ulcers and delirium, significantly increased the length of hospital stay, indicating that these complications can lead to longer recovery times, although acute AEs did not impact health-related quality of life at the time of discharge.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Incidence of acute care adverse events and long-term health-related quality of life in patients with TSCI. Street, JT., Noonan, VK., Cheung, A., et al.[2015]

A participatory design process involving 16 individuals, including 9 persons with spinal cord injuries (SCI), led to the development of an online self-management program (SCI & U) that addresses specific concerns of the SCI community.

Participants expressed a strong preference for credible, peer-led information and proposed features like a community-curated resource database and group chats to enhance trust and support in managing secondary conditions after SCI.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Participatory Design of an Online Self-Management Tool for Users With Spinal Cord Injury: Qualitative Study. Allin, S., Shepherd, J., Tomasone, J., et al.[2022]

The web-based self-management program, SCI & U, was found to be feasible and acceptable for Canadians with spinal cord injury (SCI), with 10 out of 11 participants completing the program and showing improvements in self-efficacy and health literacy after participation.

Participants reported a focus on diet and exercise during the program, and peer health coaches were identified as crucial for providing support and accountability, suggesting that such programs can positively impact resilience, mood, and management of secondary conditions associated with SCI.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Web-Based Health Coaching for Spinal Cord Injury: Results From a Mixed Methods Feasibility Evaluation. Allin, S., Shepherd, J., Thorson, T., et al.[2020]

Individuals with chronic cervical spinal cord injuries go through a three-phase process of establishing self-management: faint awareness, seeking, and adaptation, which helps them minimize disruptions in their lives and maintain community living.

While many participants learned to manage their health through self-monitoring and preventative measures, they often struggled to recognize the importance of medical care and sometimes prioritized personal beliefs over prescribed treatments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Establishing self-management for chronic spinal cord injury patients: a qualitative investigation]. Okochi, A., Tadaka, E.[2016]

References

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

A Scoping Review of Self-Management Interventions Following Spinal Cord Injury. [2021]

2. Japan pubmed.ncbi.nlm.nih.gov

Risk factors of AIS C incomplete cervical spinal cord injury for poor prognosis-The significance of anorectal evaluation. [2023]

3. England pubmed.ncbi.nlm.nih.gov

Conception and development of Self-Management indicators to advance the quality of spinal cord injury rehabilitation: SCI-High Project. [2022]

4. England pubmed.ncbi.nlm.nih.gov

Contents of physical therapy, occupational therapy, and sports therapy sessions for patients with a spinal cord injury in three Dutch rehabilitation centres. [2011]

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

Views of people with traumatic spinal cord injury about the components of self-management programs and program delivery: a Canadian pilot study. [2021]

6. England pubmed.ncbi.nlm.nih.gov

Can spinal cord injury patients show a worsening in ASIA impairment scale classification despite actually having neurological improvement? The limitation of ASIA Impairment Scale Classification. [2014]

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

Previously Identified Common Post-Injury Adverse Events in Traumatic Spinal Cord Injury-Validation of Existing Literature and Relation to Selected Potentially Modifiable Comorbidities: A Prospective Canadian Cohort Study. [2019]

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

Incidence of acute care adverse events and long-term health-related quality of life in patients with TSCI. [2015]

9. Canada pubmed.ncbi.nlm.nih.gov

Participatory Design of an Online Self-Management Tool for Users With Spinal Cord Injury: Qualitative Study. [2022]

10. Canada pubmed.ncbi.nlm.nih.gov

Web-Based Health Coaching for Spinal Cord Injury: Results From a Mixed Methods Feasibility Evaluation. [2020]

11. Japan pubmed.ncbi.nlm.nih.gov

[Establishing self-management for chronic spinal cord injury patients: a qualitative investigation]. [2016]