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Clinical Trials/NCT05664620
NCT05664620
Recruiting
Not Applicable

Development of a Persisting Concussion Symptoms (PCS) Risk Stratification Tool and Evaluation of the Effectiveness of an Enhanced WSIB Multidisciplinary Individualized Treatment Program to Enhance Return to Work and Recovery

University Health Network, Toronto1 site in 1 country75 target enrollmentFebruary 17, 2021

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Post-Concussion Syndrome
Sponsor
University Health Network, Toronto
Enrollment
75
Locations
1
Primary Endpoint
Return to work
Status
Recruiting
Last Updated
3 years ago

Overview

Brief Summary

Patients with Persisting Concussion Symptoms (PCS) have a multitude of different symptoms. Some patients are at risk of prolonged symptoms but currently there is no tool to assist in identifying patients at high risk. Intensive, multidisciplinary intervention is time-consuming and expensive and may not be warranted for all PCS patients, so it is essential to identify early on which patients are at risk of prolonged symptoms. The aim of this study is to improve the quality of care delivered to patients, especially those who are at high-risk of prolonged PCS by early identification and treatment of all the symptoms. The purpose of this research is to validate the use of a Persisting Concussion Symptoms (PCS) Risk Stratification Tool (RST).

Detailed Description

The information from 500 hundred concussion patients were used to develop the PCS RST. This is a screening tool that will assist in predicting patient outcomes by allocating patients with PCS into a low, medium and high risk group for prolonged PCS symptoms. This categorization would help target those patients at high risk of prolonged symptoms with a multidisciplinary individualized treatment and evaluate the effectiveness of it on return to work and recovery. For this research study, we ask workers who have had concussions and are categorized as high high risk (with PCS RST) for prolonged PCS symptoms to undergo individualized treatments and we will examine their recovery and return to work. The study will involve 75 patients with persisting concussion symptoms from the Canadian Concussion Centre clinics and Altum Health concussion clinic at Toronto Western Hospital.

Registry
clinicaltrials.gov
Start Date
February 17, 2021
End Date
December 31, 2024
Last Updated
3 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Age between 18-60 years old
  • Clinical diagnosis of PCS for 1-12 months with at least 3 symptoms
  • Must be employed at time of injury
  • Full-time or part-time worker prior to concussion and cannot return to work
  • Must speak English and be sufficiently literate to complete questionnaires and perform assessments
  • Must be able to give consent

Exclusion Criteria

  • Abnormalities on MRI such as contusion, hemorrhages, siderosis, or other non-traumatic conditions
  • History of neurological conditions (e.g. stroke, seizures) or major psychiatric disease

Outcomes

Primary Outcomes

Return to work

Time Frame: 12 months after treatment start day

The Primary Outcome is the percentage of concussed workers who ultimately RTW one year after the treatment commences. The Recovery and Return to Work tracker will be completed in 3,6,9 and 12 months to track their recovery. However, the primary endpoint is "Return to work at 12 months."

Secondary Outcomes

  • Work Quality(12 months after treatment start day)

Study Sites (1)

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