- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03010384
Contact to a Physician Specialized in Social Medicine and Return to Work
January 3, 2017 updated by: Kirsten Fonager
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
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Actual)
443
Phase
- Not Applicable
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 59 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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:
-
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Intervention
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.
|
|
|
No Intervention: Control
Standard treatment from the Department of Rheumatology
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Return to Work (register based information)
Time Frame: one year
|
one year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2011
Primary Completion (Actual)
December 1, 2012
Study Completion (Actual)
July 1, 2014
Study Registration Dates
First Submitted
December 6, 2016
First Submitted That Met QC Criteria
January 3, 2017
First Posted (Estimate)
January 5, 2017
Study Record Updates
Last Update Posted (Estimate)
January 5, 2017
Last Update Submitted That Met QC Criteria
January 3, 2017
Last Verified
January 1, 2017
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Reuma-2011
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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