Spinal Cord Injuries Clinical Trial
— SCISM-DOfficial title:
A Self-Management Program for Improving the Well-Being of Veterans With AIS D Incomplete Spinal Cord Injury
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.
Status | Recruiting |
Enrollment | 9 |
Est. completion date | May 31, 2025 |
Est. primary completion date | May 31, 2025 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | N/A and older |
Eligibility | Inclusion Criteria: 1. VA clinician-confirmed diagnosis of tetraplegia or paraplegia with an ASIA rating of AIS D [Veterans with AIS D SCI]; 2. Interest and ability (e.g., reliable video telehealth equipment and WiFi) to participate in the focus groups. Exclusion Criteria: 1. Currently participating in a comprehensive, inpatient rehabilitation program; 2. Diagnosis of a psychotic disorder; 3. At high risk for suicidal/homicidal behavior; 4. Active substance dependence; 5. Lack of capacity to consent to participation; 6. Any medical condition that could affect results such as advanced cancer or neurologic disease such as Parkinson's disease; and 7. 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. |
Country | Name | City | State |
---|---|---|---|
United States | Hunter Holmes McGuire VA Medical Center, Richmond, VA | Richmond | Virginia |
Lead Sponsor | Collaborator |
---|---|
VA Office of Research and Development |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Client Satisfaction Questionnaire | An 8-item measure of patient satisfaction with the intervention. Each item is rated on a 4-point scale. The full scale has a range of 8-32 with higher scores indicating more satisfaction. | 6 weeks | |
Primary | Patient Global Impression of Change | A one-item measure of self-reported change as a result of the intervention. Each item is rated on a 7-point scale: "very much improved," "much improved," "minimally improved," "no change," "minimally worse," "much worse," or "very much worse." | 6 weeks |
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