NCT07606261

Brief Summary

This prospective multicenter cohort study evaluates the predictive value of the Adaptive Load Index (ICA), a composite indicator derived from the WB6Dim well-being instrument, on long-duration sick leave (≥ 30 days) in French companies at a 6-month horizon. In France, 7% of sick leave episodes (those exceeding 6 months) account for 45% of total sickness benefit expenditure (Cour des Comptes 2024). Group disability insurance charges rose +24.4% in 2024 (France Assureurs 2025). Critically, a substantial proportion of long-duration sick leave occurs without prior escalation in administrative absence data - the 'cliff effect' - where presenteeism masks progressive deterioration (Gustafsson \& Marklund 2011). Prediction models based solely on absence history plateau at AUC 0.65 for cumulative days (Roelen 2013), while composite psychometric instruments reach C-index 0.73-0.74 (Airaksinen et al. 2018, SJWEH). The WB6Dim is a validated 28-item psychometric tool measuring 9 dimensions of workplace well-being (NCT07301879, NCT07433764; test-retest ICA .904). The ICA classifies respondents into 4 adaptive load levels. Aggregated at the company level, the ICA distribution may detect deterioration during the presenteeism window, before costly sick leave materializes. The study collects 4 WB6Dim assessments over 6 months alongside company-level absence data stratified by duration (2024-2026) and individual self-reported absence data (duration and episode count). Six pre-registered hypotheses test whether ICA predicts long-duration leave, including an exploratory hypothesis targeting companies with no prior absence signal but degraded well-being scores.

Trial Health

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Trial Health Score

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

Enrollment
2,000

participants targeted

Target at P75+ for all trials

Timeline
6mo left

Started Jun 2026

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

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

Study Progress8%
Jun 2026Nov 2026

First Submitted

Initial submission to the registry

May 17, 2026

Completed
9 days until next milestone

First Posted

Study publicly available on registry

May 26, 2026

Completed
6 days until next milestone

Study Start

First participant enrolled

June 1, 2026

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 15, 2026

Expected
15 days until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2026

Last Updated

May 26, 2026

Status Verified

May 1, 2026

Enrollment Period

6 months

First QC Date

May 17, 2026

Last Update Submit

May 17, 2026

Conditions

Keywords

WB6DimAdaptive Load Indexabsenteeism predictioncliff effectICA

Outcome Measures

Primary Outcomes (1)

  • Company-level incidence rate of sick leave episodes ≥ 30 days over 6 months, as measured from aggregated HR records

    Company-level incidence of sick leave episodes lasting 30 days or more, measured from aggregated HR data provided by each participating company for the period June-November 2026. This threshold marks the transition from short-term to long-term sickness absence in the French social security system and is associated with sharply reduced return-to-work probability.

    6 months post-enrollment

Secondary Outcomes (6)

  • Company-level incidence rate of sick leave episodes ≥ 90 days over 6 months, as measured from aggregated HR records

    6 months post-enrollment

  • Number of employees with ≥ 3 distinct absence episodes within 6 months per company, as measured from aggregated HR records

    6 months post-enrollment

  • Self-reported cumulative absence duration and episode count, as measured by WB6Dim questionnaire items

    Baseline, 3 months, and 6 months post-enrollment

  • Change in collective ICA distribution from baseline to 3 months as a predictor of sick leave ≥ 30 days between 3 and 6 months

    Baseline and 3 months (predictor); 3 to 6 months post-enrollment (outcome)

  • Change in predictive model AUC when adding DAE profile distribution to the ICA-based model for sick leave ≥ 30 days

    6 months post-enrollment

  • +1 more secondary outcomes

Study Arms (1)

Multi-company workforce cohort

Single-cohort design. All participants receive the same observational protocol: 4 WB6Dim assessments over 6 months. The predictive analysis is conducted at the company level, comparing companies above versus below the sample median of collective critical ICA proportion at T0. No group assignment is made at the individual level. Stratification is performed post-hoc based on observed ICA distributions.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Employees of French companies with 50 or more employees, recruited through employer participation agreements. Companies are sourced through occupational health networks and direct outreach. All employees meeting inclusion criteria within participating companies are eligible regardless of job type, contract status, or health condition.

You may qualify if:

  • Employee of a participating French company (≥ 50 employees)
  • Age 18 years or older
  • Access to a smartphone or computer to complete the digital questionnaire
  • Electronic informed consent provided at baseline

You may not qualify if:

  • Refusal to participate or withdrawal of consent
  • Inability to complete the questionnaire in French

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Clover Link

Bandol, 83150, France

Location

Related Links

MeSH Terms

Conditions

Occupational Stress

Condition Hierarchy (Ancestors)

Occupational DiseasesStress, PsychologicalBehavioral SymptomsBehavior

Study Officials

  • Frédérique RETORNAZ, MD, PhD

    European Hospital, Unit of Care and Research in Internal Medicine and Infectious Diseases.

    STUDY CHAIR

Central Study Contacts

Quentin ALITTA, MBA

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 17, 2026

First Posted

May 26, 2026

Study Start

June 1, 2026

Primary Completion (Estimated)

November 15, 2026

Study Completion (Estimated)

November 30, 2026

Last Updated

May 26, 2026

Record last verified: 2026-05

Data Sharing

IPD Sharing
Will not share

Individual participant data will not be shared. The study analyzes company-level aggregated indicators only. No individual diagnosis or prognosis is delivered. Sharing individual-level data would conflict with GDPR requirements and the anonymization commitments made to participants and employers in the informed consent. De-identified, aggregated company-level datasets may be made available to qualified researchers upon reasonable request and approval by the data protection officer.

Locations