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Disability Case Manager: Full Member of the Revalidation Team

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03996798
Recruitment Status : Active, not recruiting
First Posted : June 25, 2019
Last Update Posted : June 25, 2019
Sponsor:
Collaborators:
Jessa Hospital
Revalidatie & MS Centrum Overpelt
RIZIV
Information provided by (Responsible Party):
PXL University College

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.

Condition or disease Intervention/treatment Phase
Vocational Rehabilitation Other: Disability Case Manager Not Applicable

Detailed Description:

12.5% of the population is confronted with a handicap or chronic disease which complicates quality of life, including the professional activities. 58% of this group is unemployed or inactive. 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. After 1-year unemployment, vocational reintegration decreases to 20%, which means an early intervention is recommended.

The classic rehabilitation trajectory is for the greater part directed at regaining patient's independence concerning daily activities, housing conditions, hobbies and its family. Revalidation is not (or only in the end) focused on back to work.

The revalidation centre Sint-Ursula, Jessa Hospital, Hasselt developed an interdisciplinary methodology 'Back-To-Work', which included an early focus on vocational and/or social rehabilitation using a 'Disability Case Manager (DCM)'. The DCM act as key figure between the patient, the multidisciplinary team of the revalidation centre, the employers and other back-to-work services to facilitate return to work.

The program is initiated by an interdisciplinary screening at time of hospitalisation. Together with the patient, there can be chosen for two revalidation pathways: 1/ focus on vocational rehabilitation; or 2/ focus on social participation. The labour pathway includes the matching of the persons characteristics and capacity with the requirements of the job, followed by a task-oriented vocational training; the social participation pathway consists of guidance to alternative daytime activities combined with psychological support in coping and acceptance. The combination of these components with the focus on vocational rehabilitation and social participation is new in rehabilitation services.

Previous research, testing the involvement of a DCM, showed empirically better results, with more patients going back to work or choosing an alternative job. Even when back to work was eventually not possible, those patients reported a better quality of life.

This project aims at a scientifically validation of the 'Back-To-Work' methodology and the role of DCM. Patients with complex neuro-locomotoric conditions and amputations, aged between 18-62 years, will be asked to participate in a controlled, longitudinal study, receiving either a revalidation therapy including the experimental 'Back-to-work' methodology (Jessa hospital, campus Sint-Ursula) or a standard revalidation therapy (Revalidation & MS Clinic Overpelt, control group). At the start of rehabilitation, at the end of rehabilitation and 6 months after rehabilitation, data for qualitative and quantitative analysis is gathered.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 80 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Disability Case Manager: Full Member of the Revalidation Team
Actual Study Start Date : March 1, 2017
Estimated Primary Completion Date : June 30, 2020
Estimated Study Completion Date : September 30, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Rehabilitation

Arm Intervention/treatment
Experimental: Jessa Hospital, Herk-de-Stad
"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
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.

No Intervention: Revalidation and MS Clinic Overpelt
Standard revalidation therapy without explicit focus on "back to work"



Primary Outcome Measures :
  1. Change in Quality of Life: Short Form 36 questionnaire [ Time Frame: 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) ]
    Short Form 36 questionnaire. This questionnaire includes 11 questions with different scale ranges and contents.

  2. Change in mental functioning: depressive feelings, anxiety and stress [ Time Frame: 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) ]
    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.

  3. Change in functional status [ Time Frame: 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) ]
    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.

  4. Change in participation [ Time Frame: 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) ]
    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.

  5. Change in work status (questionnaire) [ Time Frame: 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) ]
    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)


Secondary Outcome Measures :
  1. Change in coping [ Time Frame: 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) ]
    Coping Inventory of Stressful Situations (CISS), the Utrecht Coping list. Scales ranges from 1 to 5 (1 = not at all, 5 = very strong).

  2. Change in self-effectiveness [ Time Frame: 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) ]
    Dutch General Self-Efficacy Scale (SES). Scale ranges from 1 to 4 (1 = completely incorrect, hardly correct, slightly correct, completely correct).

  3. Expectations concerning back-to-work [ Time Frame: pre (at moment of inclusion) ]
    Worker Role Interview. This interview includes open questions about the consequences of the incident, the current and previous employments and back to work after the revalidation.

  4. Change in satisfaction with revalidation traject [ Time Frame: post (at the end of the revalidation period, on average after 6 months) and follow-up (6 months after revalidation) ]
    Questionnaire. The scales range from 0 to 3 or 1 to 5. (0-3: 0 = strongly disagree, 1 = disagree, 2 = agree, 3 = strongly agree; 1-5: 1 = not at all, 2 = to some extent, 3 = to a reasonable extent, 4 = to a large extent, 5 = to a very large extent). The higher values represent a better outcome.

  5. Change in expectations concerning back-to-work [ Time Frame: 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) ]
    Questionnaire. The scale ranges from 1 to 5 (1 = not at all, 2 = to some extent, 3 = to a reasonable extent, 4 = to a large extent, 5 = to a very large extent). The higher values represent a better outcome.

  6. Satisfaction with revalidation traject and back-to-work focus: Semi-structured interview [ Time Frame: follow-up (6 months after revalidation) ]
    Semi-structured interview. This interview includes open questions.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 62 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03996798


Locations
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Belgium
Jessa Hospital, Campus Sint-Ursula
Hasselt, Limburg, Belgium, 3500
Revalidation & MS Clinic Overpelt
Overpelt, Limburg, Belgium, 3900
Sponsors and Collaborators
PXL University College
Jessa Hospital
Revalidatie & MS Centrum Overpelt
RIZIV
Investigators
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Principal Investigator: Annemie Spooren, PhD PXL University College
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Responsible Party: PXL University College
ClinicalTrials.gov Identifier: NCT03996798    
Other Study ID Numbers: PXL_WeerWerk
First Posted: June 25, 2019    Key Record Dates
Last Update Posted: June 25, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by PXL University College:
vocational rehabilitation
back-to-work
social participation
disability case manager