NCT05412537

Brief Summary

The current research on the impact of motivation in return to work after work disability has 2 major parts: (1) a questionnaire study for which SMEC gave approval, this part is completed, (2) a RCT. The RCT will compare two groups: (a) a consult as usual (a regular consult with the medical advisor) and (b) an intervention based on motivational interviewing performed by a medical advisor.

Trial Health

55
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
272

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Apr 2019

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
active not 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 Start

First participant enrolled

April 23, 2019

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

November 9, 2020

Completed
1.6 years until next milestone

First Posted

Study publicly available on registry

June 9, 2022

Completed
3.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 27, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 27, 2025

Completed
Last Updated

July 3, 2024

Status Verified

July 1, 2024

Enrollment Period

6.7 years

First QC Date

November 9, 2020

Last Update Submit

July 1, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • Return to work rates

    How many people have (partially) returned to work

    6 months

Secondary Outcomes (6)

  • Quality of life SF36v2

    3 months

  • Workability index

    3 months

  • motivation for work

    3 months

  • basic psychological needs

    1 week and 3 months

  • subjective experiences of the consult

    1 week and 3 months

  • +1 more secondary outcomes

Study Arms (2)

CAU

ACTIVE COMPARATOR

A sickness funds provides a physician or paramedic's consultation with people on work disability 3 to 6 months after the onset of the sickness period. The goal of this conversation is (1) to gather information on the reason of work disability, (2) gather information of the treatment plan and (3) to encourage people to RTW. CAU stands for consult as usual

Other: CAU

Motivational Interviewing

EXPERIMENTAL

Motivational Interviewing involves a conversation about behavioral change in terms of recovery or RTW. The role of the MI practitioner is to evoke change talk. By change talk, the patient expresses a desire, a reason, an ability or a need for change. It is of importance that patients themselves generate the motivation for change, and it is the practitioner's task to assist them in making informed and contemplated choices to act. The core idea is that people have to become motivated themselves to change such that the new behavior is something that they want instead of something that someone else wants. There are 4 processes: engaging, focusing, evoking and planning. Training in MI for health care professionals typically is provided in 1- to 3-day workshops. This is consistent with the 2-day training in the current research. MI was planned 3 to 6 months after the onset of work disability.

Other: MI

Interventions

MIOTHER

How to motivate people

Motivational Interviewing
CAUOTHER

consult as usual

CAU

Eligibility Criteria

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

You may qualify if:

  • speak and understand Dutch
  • work disabled for longer than a month

You may not qualify if:

  • work disabled for shorter dan 1 month or longer than 1 year
  • not having the mental capabilities to understand the questionnaire

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

KULeuven

Leuven, 3000, Belgium

Location

Related Publications (1)

  • Rymenans I, Vanovenberghe C, Du Bois M, Van den Broeck A, Lauwerier E. Process Evaluation of a Motivational Interviewing Intervention in a Social Security Setting: A Qualitative Study among Work-Disabled Patients. J Occup Rehabil. 2024 Mar;34(1):141-156. doi: 10.1007/s10926-023-10108-4. Epub 2023 Apr 2.

MeSH Terms

Conditions

CommunicationHealth Behavior

Condition Hierarchy (Ancestors)

Behavior

Study Officials

  • Marc Du Bois, Prof. dr.

    KU Leuven Environment and Health

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Model Details: The RCT will compare two groups: (a) a consult as usual (a regular consult with the medical advisor) and (b) an intervention based on motivational interviewing performed by a medical advisor.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 9, 2020

First Posted

June 9, 2022

Study Start

April 23, 2019

Primary Completion

December 27, 2025

Study Completion

December 27, 2025

Last Updated

July 3, 2024

Record last verified: 2024-07

Data Sharing

IPD Sharing
Will not share

Locations