ACCESS for Spinal Cord

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Spinal Cord+1 More
ACCESS - Behavioral
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This trial is being done to study whether an innovative employment strategy, Customized Employment, can help Veterans with Spinal Cord Injuries (SCI) find and maintain competitive integrated employment.

Eligible Conditions
  • Spinal Cord

Treatment Effectiveness

Study Objectives

1 Primary · 14 Secondary · Reporting Duration: After the intervention begins, interviews will occur during the following 3 time periods 0- 9 months, 10-21 months, and 22-33 months

6, 9 12 months
Change in Employment Status
6, 9, 12 months
Change in Employment Barriers- Employment Questionnaire
Change in Employment Satisfaction, Wages, Retention
Month 33
Change in Employment Barriers- Qualitative Interview -Provider participants
Change in Impact on Quality of Life and Participation- Qualitative Interviews Provider participants
Month 12
Change in Quality of Life- Ability to Participate in Social Roles and Activities (SRA)
Month 12
Change in Quality of Life- Positive Affect and Well-being
Change in Quality of Life- Satisfaction with SRA
Change in Quality of Life- Self Esteem
Change in Self-Sufficiency- Perceived Barrier Scale (PEBS)
Change in Self-sufficiency - Employment Hope Scale (EHS) SF-14
Baseline, 6, 9, 12, months
Changes in Quality of Life- Independence
Month 12
Adaption of Intervention- Benchmarks of Quality Checklist (BQC)
Month 12
Change in Employment Barriers- Qualitative Interview -Veteran participants
Change in Impact on Quality of Life and Participation- Qualitative Interviews Veteran participants

Trial Safety

Trial Design

2 Treatment Groups

IPS (Usual Care) Group
1 of 2
ACCESS-Vets Intervention Group
1 of 2

Active Control

Experimental Treatment

100 Total Participants · 2 Treatment Groups

Primary Treatment: ACCESS · No Placebo Group · N/A

ACCESS-Vets Intervention Group
Behavioral
Experimental Group · 1 Intervention: ACCESS · Intervention Types: Behavioral
IPS (Usual Care) Group
Behavioral
ActiveComparator Group · 1 Intervention: IPS · Intervention Types: Behavioral
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
ACCESS
2017
N/A
~800

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: after the intervention begins, interviews will occur during the following 3 time periods 0- 9 months, 10-21 months, and 22-33 months

Who is running the clinical trial?

VA Office of Research and DevelopmentLead Sponsor
1,474 Previous Clinical Trials
2,741,594 Total Patients Enrolled
Lisa Ottomanelli, PhDPrincipal InvestigatorJames A. Haley Veterans' Hospital, Tampa, FL
2 Previous Clinical Trials
1,296 Total Patients Enrolled

Eligibility Criteria

Age 18+ · All Participants · 6 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You are a community-dwelling, English-speaking veteran.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 24th, 2021

Last Reviewed: November 16th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.

Who else is applying?

What state do they live in?
Texas100.0%
How old are they?
18 - 65100.0%
What site did they apply to?
Hunter Holmes McGuire VA Medical Center, Richmond, VA100.0%
What portion of applicants met pre-screening criteria?
Met criteria100.0%