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Contact to a Physician Specialized in Social Medicine and Return to Work

Primary Purpose

Return to Work, Musculoskeletal Disease

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Rehabilitation program
Sponsored by
Kirsten Fonager
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Return to Work

Eligibility Criteria

18 Years - 59 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • age ≥ 18 and < 60 years old,
  • not receiving disability pension and not on maternity leave.
  • sick leave over the past year for more than ten days
  • low self-rated work ability for the next two years
  • health anxiety

Exclusion Criteria:

-

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    No Intervention

    Arm Label

    Intervention

    Control

    Arm Description

    Consultation with a physician specialized in social medicine. The consultation lasted about one hour. Together with the patient a return-to-work (RTW) schedule was made to ascertain the need for contact to the workplace (to adjust work functions), municipality, general practitioner or short-term supportive consultations with a psychologist. If relevant, patients were offered up till 5 sessions with a psychologist.

    Standard treatment from the Department of Rheumatology

    Outcomes

    Primary Outcome Measures

    Return to Work (register based information)

    Secondary Outcome Measures

    Full Information

    First Posted
    December 6, 2016
    Last Updated
    January 3, 2017
    Sponsor
    Kirsten Fonager
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03010384
    Brief Title
    Contact to a Physician Specialized in Social Medicine and Return to Work
    Official Title
    Contact to a Physician Specialized in Social Medicine and the Impact on Return to Workforce in Patients Suspected of Disc Herniation? - a Randomized Controlled Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    January 2017
    Overall Recruitment Status
    Completed
    Study Start Date
    January 2011 (undefined)
    Primary Completion Date
    December 2012 (Actual)
    Study Completion Date
    July 2014 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor-Investigator
    Name of the Sponsor
    Kirsten Fonager

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    The aim of this study was to investigate the impact of a rehabilitation program including a physician specialized in social medicine parallel to treatment for suspected spinal disc herniation.
    Detailed Description
    In a two-year time period (2011 to 2012) 443 patients of suspected of disc herniation and risk of low work ability - based on questionnaires participated in a randomized control trial. The patients were randomized to either the intervention group (n=220) or control group (n=223). The intervention group were invited to the Department of Social Medicine two to four weeks after their first contact to Department of Rheumatology for a consultation with a physician specialized in social medicine. Together with the patient a return-to-work (RTW) schedule was made to ascertain the need for contact to the workplace (to adjust work functions), municipality, general practitioner or short-term supportive consultations with a psychologist. Throughout the intervention, the patients received their usual treatment from the Department of Rheumatology like patients from the control group. Outcome was return to the work force at one year follow up using information from a national registry.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Return to Work, Musculoskeletal Disease

    7. Study Design

    Primary Purpose
    Supportive Care
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    443 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Intervention
    Arm Type
    Active Comparator
    Arm Description
    Consultation with a physician specialized in social medicine. The consultation lasted about one hour. Together with the patient a return-to-work (RTW) schedule was made to ascertain the need for contact to the workplace (to adjust work functions), municipality, general practitioner or short-term supportive consultations with a psychologist. If relevant, patients were offered up till 5 sessions with a psychologist.
    Arm Title
    Control
    Arm Type
    No Intervention
    Arm Description
    Standard treatment from the Department of Rheumatology
    Intervention Type
    Other
    Intervention Name(s)
    Rehabilitation program
    Primary Outcome Measure Information:
    Title
    Return to Work (register based information)
    Time Frame
    one year

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    59 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: age ≥ 18 and < 60 years old, not receiving disability pension and not on maternity leave. sick leave over the past year for more than ten days low self-rated work ability for the next two years health anxiety Exclusion Criteria: -

    12. IPD Sharing Statement

    Learn more about this trial

    Contact to a Physician Specialized in Social Medicine and Return to Work

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