Self-Management Program for AIS D SCI

NCT05800717 | Withdrawn Phase 1

• 2 other identifiers: D4417-P1I21RX004417-01A1
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Psychological Well-Being; Spinal Cord Injuries

Keywords

Spinal Cord Injuries; Psychological Well-Being; Clinical trial

Outcome Measures

Primary Outcomes (2)

• 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

• 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

Study Arms (1)

Treatment

OTHER

Receives SCISM-D.

Behavioral: SCI Self-Management for AIS D

Interventions

SCI Self-Management for AIS D BEHAVIORAL

An individually administered, self-management intervention for Veterans with AIS D spinal cord injury.

Treatment

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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;
• Any medical condition that could affect results such as advanced cancer or neurologic disease such as Parkinson's disease; and

Sponsors & Collaborators

• VA Office of Research and Development: lead

Study Sites (1)

Richmond VA Medical Center, Richmond, VA

Richmond, Virginia, 23249-0001, United States

Location

MeSH Terms

Conditions

Psychological Well-Being; Spinal Cord Injuries

Condition Hierarchy (Ancestors)

Personal Satisfaction; Behavior; Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries

Study Officials

• Scott D McDonald, PhD

  Richmond VA Medical Center, Richmond, VA

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: FED
• Responsible Party: SPONSOR

Model Details: single group, successive cohort design

Study Record Dates

• First Submitted: March 23, 2023
• First Posted: April 6, 2023
• Study Start: May 1, 2024
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: March 13, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)