NCT05370872

Brief Summary

Currently, injured workers are required to visit a clinic, in-person, for functional testing as part of the rehabilitation and return-to-work process. The need for in-person testing has always caused problems for workers in remote areas without easy access to clinics. COVID-19 has made the problem of access to in-person clinical testing worse. Now, many injured workers can't receive functional testing due to COVID-19 related clinic closures and isolation restrictions. The investigators aim to develop and evaluate a functional testing protocol that can be delivered remotely to solve the problem of access to in-person clinic testing. A functional test that can be completed remotely, while the client remains in their home will increase access to timely testing, improve client satisfaction by removing the need for costly and time consuming travel, and will continue to help injured workers quickly recover and return to meaningful work. This research study will help to determine if return-to-work outcomes improve, or remain unchanged, when functional testing is completed remotely relative to in the clinic.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
90

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Nov 2022

Geographic Reach
1 country

5 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 2, 2022

Completed
10 days until next milestone

First Posted

Study publicly available on registry

May 12, 2022

Completed
6 months until next milestone

Study Start

First participant enrolled

November 1, 2022

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2023

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2024

Completed
Last Updated

April 16, 2024

Status Verified

November 1, 2022

Enrollment Period

1.2 years

First QC Date

May 2, 2022

Last Update Submit

April 12, 2024

Conditions

Keywords

Functional capacity evaluationReturn to workFunctional testingMotivational interviewingTelehealth

Outcome Measures

Primary Outcomes (3)

  • Return to work recommendation at intake

    When referred to an musculoskeletal program of care, clients are classified into return to work categories based on their ability to meet job requirements as measured by the clinician using the functional testing protocol. The return to work recommendation at intake is used to inform the rehabilitation program.

    Baseline measure - a intake into the rehabilitation program

  • Return to work recommendation at discharge

    Once the client has completed a musculoskeletal program of care, clients are again classified into return to work categories based on their ability to meet job requirements as measured by the clinician using the functional testing protocol. The return to work recommendation at discharge is used to inform how the client is reintegrated into their workplace.

    At program discharge (approximately 8-12 weeks post intake, where each client will receive a tailored program based on their return to work recommendation at intake)

  • Return to work status

    Clients will be aske to describe their current work status at three-months post discharge by selecting 1 of 5 options (work regular, full time duties; work regular, part time duties, work light duty or modified position full time; work light duty or modified position part time; not currently working)

    three-months post discharge

Secondary Outcomes (2)

  • Adverse events

    Through study completion, and average of 1 year

  • Client experience and satisfaction

    one-week post initial functional testing session

Study Arms (2)

Care-as-usual

NO INTERVENTION

Clients in this group will complete functional testing in the clinic using the care-as-usual approach.

Remote functional testing

EXPERIMENTAL

Clients in this group will complete functional testing using the remote functional testing approach.

Diagnostic Test: Remote functional testing protocol

Interventions

Clients in the remote functional testing protocol group will be asked to describe their functional capacity limits using a clinician guided motivational interviewing approach and will also be asked to complete a mobility screening protocol to provide the clinician with the opportunity to observe the clients natural movements.

Remote functional testing

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Injured workers with accepted Workplace Safety and Insurance Board (WSIB) of Ontario claims referred to CBI Health for WSIB Specialty Programs related to musculoskeletal injuries of either Back and Neck, or Upper Extremity.

You may not qualify if:

  • Under the age of 18 years,
  • referred for surgery during the time of the rehabilitation programming,
  • have a concurrent traumatic brain injury or mental health disorder that takes precedence over the musculoskeletal injury, or
  • require the assistance of an interpreter to read, write or speak English.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

CBIH London Dundas

London, Ontario, N5W 3C6, Canada

Location

CBIH London Fanshawe

London, Ontario, N6G 0W7, Canada

Location

CBIH London Wonderland

London, Ontario, N6K 3X4, Canada

Location

CBIH Nepean

Nepean, Ontario, K2H 5V6, Canada

Location

CBIH St. Laurent

Ottawa, Ontario, K1K 4H4, Canada

Location

Related Publications (1)

  • Gross DP, Asante AK, Miciak M, Battie MC, Carroll LJ, Sun A, Mikalsky M, Huellstrung R, Niemelainen R. A cluster randomized clinical trial comparing functional capacity evaluation and functional interviewing as components of occupational rehabilitation programs. J Occup Rehabil. 2014 Dec;24(4):617-30. doi: 10.1007/s10926-013-9491-4.

Study Officials

  • Steve Fischer

    Associate Professor, University of Waterloo

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
The individual responsible for comparing return-to-work outcome between groups will be blind to the group assignments
Purpose
SCREENING
Intervention Model
PARALLEL
Model Details: Cluster randomized controlled trial. Clinicians will be randomly assigned to administer the functional testing protocol in-person (care-as-usual) or remotely (the intervention). Clients will complete the functional testing protocol based on the group assignment of the clinician to whom they were referred to.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 2, 2022

First Posted

May 12, 2022

Study Start

November 1, 2022

Primary Completion

December 31, 2023

Study Completion

March 31, 2024

Last Updated

April 16, 2024

Record last verified: 2022-11

Data Sharing

IPD Sharing
Will not share

Individual participant data will not be shared with other researchers.

Locations