- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03729050
Rehabilitation Coordinators in Specialist Psychiatry
June 29, 2020 updated by: Ingrid Anderzen, Uppsala University
REKO-A is a randomized controlled intervention study that addressed women and men on sick leave in Uppsala County.
Participants which are on sick leave due to mental illness.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
200
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Uppsala, Sweden, SE-75122
- Recruiting
- Uppsala University
-
Contact:
- Åsa Andersén, PHD
- Phone Number: 00184716575
- Email: asa.andersen@pubcare.uu.se
-
Principal Investigator:
- Ingrid Anderzén, PHD
-
-
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
25 years to 64 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Be on sick leave
- Have moderate to severe affective and / or moderate / severe anxiety disorder, such as: Bipolar disorder, depression, posttraumatic stress disorder, generalized anxiety disorder, neuropsychiatric disability
- Enrolled at the Academic hospital in Uppsala
Exclusion Criteria:
- High suicidal risk
- Extensive somatic disorders (somatic multichannel)
- Patients outside Uppsala County
- Taking part in an ongoing vocational rehabilitation
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: Health Services Research
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
No Intervention: Control
|
|
Experimental: Intervention with rehabilitation coordinator
|
Rehabilitation Coordinator service in Specialist Psychiatry
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Return to work (RTW)/entry into work or studies
Time Frame: 1 year
|
Number of Participants that have RTW/entry into work or studies
|
1 year
|
Magnitude of sick leave
Time Frame: 1 year
|
Proportion of sick leave in the study population
|
1 year
|
Length of sick leave
Time Frame: 1 year
|
Sick leave duration
|
1 year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
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 (Actual)
October 24, 2018
Primary Completion (Anticipated)
December 31, 2020
Study Completion (Anticipated)
December 31, 2021
Study Registration Dates
First Submitted
October 31, 2018
First Submitted That Met QC Criteria
October 31, 2018
First Posted (Actual)
November 2, 2018
Study Record Updates
Last Update Posted (Actual)
June 30, 2020
Last Update Submitted That Met QC Criteria
June 29, 2020
Last Verified
June 1, 2020
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- REKO-A
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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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