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出境医 / 临床实验 / Disability Case Manager: Full Member of the Revalidation Team

Disability Case Manager: Full Member of the Revalidation Team

Study Description
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.

Study Design
Layout table for study information
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
Actual Primary Completion Date : June 30, 2020
Actual Study Completion Date : September 30, 2020
Arms and Interventions
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"
Outcome Measures
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.


Eligibility Criteria
Layout table for eligibility information
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
Contacts and Locations

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
Layout table for investigator information
Principal Investigator: Annemie Spooren, PhD PXL University College
Tracking Information
First Submitted Date  ICMJE June 4, 2019
First Posted Date  ICMJE June 25, 2019
Last Update Posted Date January 22, 2021
Actual Study Start Date  ICMJE March 1, 2017
Actual Primary Completion Date June 30, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 24, 2019)
  • 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.
  • 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.
  • 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.
  • 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.
  • 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)
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 24, 2019)
  • 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).
  • 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).
  • 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.
  • 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.
  • 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.
  • 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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Disability Case Manager: Full Member of the Revalidation Team
Official Title  ICMJE Disability Case Manager: Full Member of the Revalidation Team
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.
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Condition  ICMJE Vocational Rehabilitation
Intervention  ICMJE 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.
Study Arms  ICMJE
  • 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"
    Intervention: Other: Disability Case Manager
  • No Intervention: Revalidation and MS Clinic Overpelt
    Standard revalidation therapy without explicit focus on "back to work"
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 24, 2019)
80
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE September 30, 2020
Actual Primary Completion Date June 30, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 62 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Belgium
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03996798
Other Study ID Numbers  ICMJE PXL_WeerWerk
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party PXL University College
Study Sponsor  ICMJE PXL University College
Collaborators  ICMJE
  • Jessa Hospital
  • Revalidatie & MS Centrum Overpelt
  • RIZIV
Investigators  ICMJE
Principal Investigator: Annemie Spooren, PhD PXL University College
PRS Account PXL University College
Verification Date January 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP