NCT06397326

Brief Summary

This study aims to assess the effectiveness of PRATICAdr 2.0, a web application facilitated by a Return-to-Work Coordinator (RTW-C), with a focus on reducing sick leave duration and preventing relapse in individuals with CMDs. PRATICAdr 2.0 designed to enhance collaboration among Return-to-Work (RTW) stakeholders and provide systematic support throughout the RTW process, is evaluated in a randomized control trial (RCT). As part of the RCT, a total of 80 sick leave employees from 4 large public health organizations (n=80, 40 from the experimental group and 40 from the control group) will be recruited. The control group receives usual services offered by a RTW-C to sick leave employees, while the experimental group receives RTW-C services plus the use of PRATICAdr 2.0.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2024

Typical duration for not_applicable

Status
not yet recruiting

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 5, 2024

Completed
27 days until next milestone

First Posted

Study publicly available on registry

May 2, 2024

Completed
4 days until next milestone

Study Start

First participant enrolled

May 6, 2024

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 15, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 15, 2026

Completed
Last Updated

May 2, 2024

Status Verified

April 1, 2024

Enrollment Period

1.9 years

First QC Date

April 5, 2024

Last Update Submit

April 29, 2024

Conditions

Keywords

Return to workSick leave durationRelapsesClinical symptoms

Outcome Measures

Primary Outcomes (2)

  • Sick leave duration

    The number of days during the sick leave

    through study completion, an average of 2 years

  • Relapses

    Number of relapses after returning to work

    through study completion, an average of 2 years

Secondary Outcomes (3)

  • Depressive symptoms

    through study completion, an average of 2 years

  • Anxiety symptoms

    through study completion, an average of 2 years

  • Return to Work Obstacles and Self-Efficacy

    through study completion, an average of 2 years

Other Outcomes (4)

  • Social functioning

    through study completion, an average of 2 years

  • Working alliance

    through study completion, an average of 2 years

  • Work accommodations

    through study completion, an average of 2 years

  • +1 more other outcomes

Study Arms (2)

Return to work coordinator + PRATICAdr 2.0

EXPERIMENTAL

The primary objective of the Return to work coordinator (RTW-C) is to coordinate, plan, and promote sustainable RTW for employees on sick leave.The RTW-C is responsible for assessing employee functioning while exploring barriers to RTW and available resources to develop a RTW plan. Also, RTW-C enhance communication and collaboration among stakeholders involved in the RTW process. In this arm, the RTW-C uses PRATICAdr 2.0, a web application including key features (e.g., Facilitation of collaboration among multiple RTW stakeholders across healthcare, enterprise, and insurance sectors; Integration of each stakeholder's action into the sick leave employee's RTW process; sequential process aligned with the three phases of the RTW, inclusion of tools).

Behavioral: Return to work coordinator + PRATICAdr 2.0

Return to work coordinator only

SHAM COMPARATOR

The primary objective of the Return to work coordinator (RTW-C) is to coordinate, plan, and promote sustainable RTW for employees on sick leave.The RTW-C is responsible for assessing employee functioning while exploring barriers to RTW and available resources to develop a RTW plan. Also, RTW-C enhance communication and collaboration among stakeholders involved in the RTW process. In this arm, the RTW-C does not use PRATICAdr 2.0.

Behavioral: Return to work coordinator only

Interventions

The Return to work coordinator (RTW-C) uses PRATICAdr. 2.0 (web application).

Return to work coordinator + PRATICAdr 2.0

The Return to work coordinator (RTW-C) intervenes on employees on sick leave as usual

Return to work coordinator only

Eligibility Criteria

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

You may qualify if:

  • Sick leave due to Common mental disorder (i.e. depression, anxiety, adjustment disorder, burnout)
  • Sick leave duration (from 1 to 3 months)
  • Member of participating unions in the large health organization

You may not qualify if:

  • Inability to communicate in French
  • Have a known organic disorder
  • Have a professional dirsorder (CNESST)
  • Have experienced previous sick leaves due to Common mental disorder

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Recurrence

Condition Hierarchy (Ancestors)

Disease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Central Study Contacts

Marc Corbière, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: Two groups: Experimental: Return to work coordinator + PRATICAdr 2.0 Control group: Return to work coordinator only
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Full professor

Study Record Dates

First Submitted

April 5, 2024

First Posted

May 2, 2024

Study Start

May 6, 2024

Primary Completion

April 15, 2026

Study Completion

April 15, 2026

Last Updated

May 2, 2024

Record last verified: 2024-04