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Completed

NCT Number: NCT03996798

Disability Case Manager: Full Member of the Revalidation Team

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.

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Key information

Age range

18 year–62 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Jessa Hospital, Campus Sint-Ursula, Hasselt, Limburg, Belgium

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Disability Case Manager

Other

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.

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

PXL University College

Other

Collaborators

  • Jessa Hospital
  • RIZIV
  • Revalidatie & MS Centrum Overpelt

Registry information

Important dates

Study start
2017
Primary completion
2020
Study completion
2020
First posted
Jun 25, 2019
Registry last updated
Jan 22, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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