NCT03996798

Brief Summary

The first 4-6 months after an incident which caused a handicap or chronic disease, it is important to involve and motivate patients to return to work. After this period, there is a major decrease on successful vocational reintegration. To facilitate vocational rehabilitation a Disability Case Manager (DCM) may play a major role. The DCM will act as key figure between the patient, the multidisciplinary team of the revalidation centre, the employers and other back-to-work services. There is need to provide evidence on the value of this program. The aim of this study is to test the added value of including a DCM in the classic revalidation trajectory, who will focus on early vocational and/or social rehabilitation.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2017

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

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

March 1, 2017

Completed
2.3 years until next milestone

First Submitted

Initial submission to the registry

June 4, 2019

Completed
21 days until next milestone

First Posted

Study publicly available on registry

June 25, 2019

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2020

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2020

Completed
Last Updated

January 22, 2021

Status Verified

January 1, 2021

Enrollment Period

3.3 years

First QC Date

June 4, 2019

Last Update Submit

January 20, 2021

Conditions

Keywords

vocational rehabilitationback-to-worksocial participationdisability case manager

Outcome Measures

Primary Outcomes (5)

  • Change in Quality of Life: Short Form 36 questionnaire

    Short Form 36 questionnaire. This questionnaire includes 11 questions with different scale ranges and contents.

    pre (at moment of inclusion), post (at the end of the revalidation period, on average after 6 months) and follow-up (6 months after revalidation)

  • Change in mental functioning: depressive feelings, anxiety and stress

    Depression, Anxiety and Stress scale 21 questionnaire. Scale ranges from 0 to 3 (0 = never applicable, 1 = sometimes applicable, 2 = often applicable, 3 = certainly applicable). The lower values represent a better outcome.

    pre (at moment of inclusion), post (at the end of the revalidation period, on average after 6 months) and follow-up (6 months after revalidation)

  • Change in functional status

    Barthel Activities of Daily Living (ADL) index. Scale ranges from 0 to 2 or 3, each topic (feeding, bathing, grooming, dressing, bowels, bladder, toilet use, transfers (bed to chair and back), mobility and stairs) has its own scale content. The higher values represent a better outcome.

    pre (at moment of inclusion), post (at the end of the revalidation period, on average after 6 months) and follow-up (6 months after revalidation)

  • Change in participation

    Nottingham ADL index. Scale ranges from 0 to 3 (0 = patient can not execute the activity, 1 = patient can execute the activity with help, 2 = patient can execute the activity, but it is still difficult, 3 = patient can execute the activity easily). The higher values represent a better outcome.

    pre (at moment of inclusion), post (at the end of the revalidation period, on average after 6 months) and follow-up (6 months after revalidation)

  • Change in work status (questionnaire)

    Follow up of current working status. Scales ranges from 0 to 7 (0 = no work, 1 = retirement, 2 = volunteer work, 3 = still in support of re-employment, 4 = half time other work, 5 = other work, 6 = half time same work, 7 = same work)

    pre (at moment of inclusion), post (at the end of the revalidation period, on average after 6 months) and follow-up (6 months after revalidation)

Secondary Outcomes (6)

  • Change in coping

    pre (at moment of inclusion), post (at the end of the revalidation period, on average after 6 months) and follow-up (6 months after revalidation)

  • Change in self-effectiveness

    pre (at moment of inclusion), post (at the end of the revalidation period, on average after 6 months) and follow-up (6 months after revalidation)

  • Expectations concerning back-to-work

    pre (at moment of inclusion)

  • Change in satisfaction with revalidation traject

    post (at the end of the revalidation period, on average after 6 months) and follow-up (6 months after revalidation)

  • Change in expectations concerning back-to-work

    pre (at moment of inclusion), post (at the end of the revalidation period, on average after 6 months) and follow-up (6 months after revalidation)

  • +1 more secondary outcomes

Study Arms (2)

Jessa Hospital, Herk-de-Stad

EXPERIMENTAL

"Back to Work" methodology: a revalidation trajectory with standard revalidation therapy in combination with an early focus on "back to work", using a "Disability Case Manager"

Other: Disability Case Manager

Revalidation and MS Clinic Overpelt

NO INTERVENTION

Standard revalidation therapy without explicit focus on "back to work"

Interventions

The DCM will act as key figure between the patient, the multidisciplinary team of the revalidation centre, the employers and other back-to-work services in order to increase vocational reintegration after an incident which caused a handicap or chronic disease.

Jessa Hospital, Herk-de-Stad

Eligibility Criteria

Age18 Years - 62 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Complex neuro-motoric conditions
  • Age between 18-62 year
  • Working
  • Persons belonging to the National Institute for Health and Disability Insurance (NIHDI) target group

You may not qualify if:

  • Comatose patients
  • Retired patients
  • Students
  • Persons who not belong to the NIHDI target group

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Jessa Hospital, Campus Sint-Ursula

Hasselt, Limburg, 3500, Belgium

Location

Revalidation & MS Clinic Overpelt

Overpelt, Limburg, 3900, Belgium

Location

Study Officials

  • Annemie Spooren, PhD

    PXL University College

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 4, 2019

First Posted

June 25, 2019

Study Start

March 1, 2017

Primary Completion

June 30, 2020

Study Completion

September 30, 2020

Last Updated

January 22, 2021

Record last verified: 2021-01

Data Sharing

IPD Sharing
Will not share

Locations