Injuries, Spinal Cord Clinical Trial
Official title:
A Patient Centered Approach to Successful Community Transition After Catastrophic Injury: Clinical Trial to Evaluate One-to-one Peer Mentoring
NCT number | NCT02274649 |
Other study ID # | 581327-1 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | April 2014 |
Est. completion date | April 2016 |
Verified date | January 2019 |
Source | Shepherd Center, Atlanta GA |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The research will examine the effects of enhanced peer mentor interactions on facilitating a successful transition to community living following traumatic spinal cord injury (SCI). Participants in the research will be assigned to either (1) the control group that will receive traditional peer mentor types of interactions or (2) to the intervention group that will receive an enhanced peer mentor program called the One-on-One Initiative. Assignment to one of these two groups will occur randomly on admission to Shepherd Center; the only stratifying criteria is injury level - C6 and above vs. C7 and below.
Status | Completed |
Enrollment | 194 |
Est. completion date | April 2016 |
Est. primary completion date | April 2016 |
Accepts healthy volunteers | No |
Gender | All |
Age group | N/A and older |
Eligibility |
Inclusion Criteria: - • All patients admitted to Shepherd Center for rehabilitation following spinal cord injury and discharged to a community setting Exclusion Criteria: - • Not discharged from Shepherd Center - • Discharged from Shepherd Center to non-community setting |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Shepherd Center, Atlanta GA |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Self-efficacy Scale. It Includes an Adapted Self-efficacy Scale From Chronic Disease Literature Focused on Confidence in Managing Self-care Needs Plus Project-specific Items for Assessment of Confidence Regarding Integration Into Community Life. | The General Self-Efficacy scale (6 items) developed at Stanford University for persons with chronic health conditions was adapted for persons with spinal cord injury. Added to this scale were 5 similarly constructed project-specific self-efficacy items focused on community navigation and accessibility (major focus of peer support program). Respondents (via telephone interview) provided a response to each of 11 items using a 10-point Likert scale ranging from 1 (not confident) to 10 (very confident). Item response scores were averaged for the total self-efficacy score. Total scores ranged from 11 to 110 (11 items with 10 response options). Higher scores indicate greater self-efficacy to manage injury conditions. Growth Curve Analysis was used to determined significant changes over time in self-efficacy. Initial status coefficients depict where participants begin at the first time point (3 days post discharge) and growth rate coefficients show how participants change over time. |
3 days post rehabilitation discharge through 180 days post discharge | |
Primary | Rehospitalization - Number of Days | Rehospitalization days (number) within 30 days post inpatient rehabilitation discharge | 30 days | |
Primary | Rehospitalization - Percent of Patients Rehospitalized | Percent of patients rehospitalized at 30 days post discharge from inpatient rehabilitation | 30 days | |
Secondary | Rehospitalization - Number of Days (Cumulative) | Rehospitalization days (cumulative) within 90 days post inpatient rehabilitation discharge | 90 days | |
Secondary | Rehospitalization - Percent of Patients Rehospitalized (90 Days) | Percent of patients (cumulative) rehospitalized within 90 days post discharge from inpatient rehabilitation | 90 days | |
Secondary | Rehospitalization - Number of Days (Cumulative) | Rehospitalization days (cumulative) within 180 days post inpatient rehabilitation discharge | 180 days | |
Secondary | Rehospitalization - Percent of Patients (180 Days) | Percent of patients (cumulative) rehospitalized within 180 days post discharge from inpatient rehabilitation | 180 days |
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