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Rehabilitation Coordinators in Specialist Psychiatry

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ClinicalTrials.gov Identifier: NCT03729050
Recruitment Status : Recruiting
First Posted : November 2, 2018
Last Update Posted : June 30, 2020
Sponsor:
Information provided by (Responsible Party):
Ingrid Anderzen, Uppsala University

Tracking Information
First Submitted Date  ICMJE October 31, 2018
First Posted Date  ICMJE November 2, 2018
Last Update Posted Date June 30, 2020
Actual Study Start Date  ICMJE October 24, 2018
Estimated Primary Completion Date December 31, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 30, 2019)
  • Return to work (RTW)/entry into work or studies [ Time Frame: 1 year ]
    Number of Participants that have RTW/entry into work or studies
  • Magnitude of sick leave [ Time Frame: 1 year ]
    Proportion of sick leave in the study population
  • Length of sick leave [ Time Frame: 1 year ]
    Sick leave duration
Original Primary Outcome Measures  ICMJE
 (submitted: October 31, 2018)
RTW [ Time Frame: 1 year ]
Return to work
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Rehabilitation Coordinators in Specialist Psychiatry
Official Title  ICMJE Rehabilitation Coordinators in Specialist Psychiatry
Brief Summary 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Condition  ICMJE
  • Mental Disorder
  • Rehabilitation
Intervention  ICMJE Behavioral: Rehabilitation Coordinator in Specialist Psychiatry
Rehabilitation Coordinator service in Specialist Psychiatry
Study Arms  ICMJE
  • Experimental: Intervention with rehabilitation coordinator
    Intervention: Behavioral: Rehabilitation Coordinator in Specialist Psychiatry
  • No Intervention: Control
Publications * Andersén Å, Berglund E, Anderzén I. Rehabilitation coordinator intervention versus control in psychiatric specialist care for return to work and reduced sick leave: study protocol of a randomised controlled trial. BMC Public Health. 2020 Feb 19;20(1):250. doi: 10.1186/s12889-020-8238-3.

*   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 Recruiting
Estimated Enrollment  ICMJE
 (submitted: October 30, 2019)
200
Original Estimated Enrollment  ICMJE
 (submitted: October 31, 2018)
400
Estimated Study Completion Date  ICMJE December 31, 2021
Estimated Primary Completion Date December 31, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 25 Years to 64 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Listed Location Countries  ICMJE Sweden
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03729050
Other Study ID Numbers  ICMJE REKO-A
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 Ingrid Anderzen, Uppsala University
Study Sponsor  ICMJE Uppsala University
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Uppsala University
Verification Date June 2020

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