Self-Management Program for AIS D SCI (NCT05800717) | Clinical Trial Compass
WithdrawnPhase 1/2
Self-Management Program for AIS D SCI
Stopped: Staffing unavailable.
United States0Started 2024-05-01
Plain-language summary
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.
Who can participate
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
. Currently participating in a comprehensive, inpatient rehabilitation program;
. Diagnosis of a psychotic disorder;
. At high risk for suicidal/homicidal behavior;
. Active substance dependence;
. Lack of capacity to consent to participation;
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
. Any medical condition that could affect results such as advanced cancer or neurologic disease such as Parkinson's disease; and
. Mental disorders such as posttraumatic stress disorder and depressive disorder will not be exclusions, but any medications must have been stable for at least 30 days prior to enrollment.