Clinical Trial to Evaluate One-to-one Peer Mentoring

NCT02274649 | Completed Results

• 1 other identifier: 581327-1
• Study Type: interventional
• Target: 194
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Injuries, Spinal Cord

Outcome Measures

Primary Outcomes (3)

• 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

• Rehospitalization - Number of Days

  Rehospitalization days (number) within 30 days post inpatient rehabilitation discharge

  30 days

• Rehospitalization - Percent of Patients Rehospitalized

  Percent of patients rehospitalized at 30 days post discharge from inpatient rehabilitation

  30 days

Secondary Outcomes (4)

• Rehospitalization - Number of Days (Cumulative)

  90 days

• Rehospitalization - Percent of Patients Rehospitalized (90 Days)

  90 days

• Rehospitalization - Number of Days (Cumulative)

  180 days

• Rehospitalization - Percent of Patients (180 Days)

  180 days

Study Arms (2)

Intervention

EXPERIMENTAL

Intervention group receiving one-to-one peer mentoring

Behavioral: one-to-one peer mentoring

Control

ACTIVE COMPARATOR

Control group receiving general peer support

Behavioral: general peer support

Interventions

one-to-one peer mentoring BEHAVIORAL

Each patient received one-to-one peer mentoring each week during rehabilitation and for 90 days post discharge

Intervention

general peer support BEHAVIORAL

General (traditional) peer support includes introduction and provision of support services upon request

Control

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• All patients admitted to Shepherd Center for rehabilitation following spinal cord injury and discharged to a community setting

You may not qualify if:

• Not discharged from Shepherd Center
• Discharged from Shepherd Center to non-community setting

Sponsors & Collaborators

• Shepherd Center, Atlanta GA: lead

Related Publications (1)

• Gassaway J, Jones ML, Sweatman WM, Hong M, Anziano P, DeVault K. Effects of Peer Mentoring on Self-Efficacy and Hospital Readmission After Inpatient Rehabilitation of Individuals With Spinal Cord Injury: A Randomized Controlled Trial. Arch Phys Med Rehabil. 2017 Aug;98(8):1526-1534.e2. doi: 10.1016/j.apmr.2017.02.018. Epub 2017 Mar 23.

  PMID: 28342829 DERIVED

MeSH Terms

Conditions

Spinal Cord Injuries

Condition Hierarchy (Ancestors)

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

Limitations and Caveats

Control group received requested peer support services; may have contributed to the relatively modest effect size. We cannot claim use of validated measure of self-efficacy; we adapted a measurement validated in other populations and added items.

Results Point of Contact

• Title: Michael Jones, PhD, Director Research
• Organization: Shepherd Center

mike_jones@shepherd.org

4043507595

Study Officials

• Michael Jones, PhD

  VP Clinical Research

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Interviewer collecting outcomes data was not aware of group assignment
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Direct Wellness Research

Study Record Dates

• First Submitted: October 22, 2014
• First Posted: October 24, 2014
• Study Start: April 1, 2014
• Primary Completion: April 1, 2016
• Study Completion: April 1, 2016
• Last Updated: February 4, 2019
• Results First Posted: February 4, 2019

Record last verified: 2019-01