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The Development Path

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ClinicalTrials.gov Identifier: NCT02641704
Recruitment Status : Completed
First Posted : December 29, 2015
Last Update Posted : October 11, 2018
Sponsor:
Collaborator:
Sonderborg Municipality
Information provided by (Responsible Party):
Lotte Nygaard Andersen, University of Southern Denmark

Tracking Information
First Submitted Date December 22, 2015
First Posted Date December 29, 2015
Last Update Posted Date October 11, 2018
Actual Study Start Date February 2016
Actual Primary Completion Date March 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: December 22, 2015)
Well-being [ Time Frame: 12 months ]
World Health Organization-5
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: February 1, 2016)
  • Well-being [ Time Frame: 24 months ]
    World Health Organization-5
  • Work ability [ Time Frame: 12 months ]
    10-points Likert scale
  • Work ability [ Time Frame: 24 months ]
    10-points Likert scale
  • Pain [ Time Frame: 12 months ]
    Visual analogue scale
  • Pain [ Time Frame: 24 months ]
    Visual analogue scale
  • Interpersonal Problems [ Time Frame: 12 months ]
    Inventory of Interpersonal Problems-64
  • Interpersonal Problems [ Time Frame: 24 months ]
    Inventory of Interpersonal Problems-64
  • Physical capacity [ Time Frame: 12 months ]
    10-points Likert scale, 5 domains
  • Physical capacity [ Time Frame: 24 months ]
    10-points Likert scale, 5 domains
  • Kinesiophobia [ Time Frame: 12 months ]
    Tampa Scale for Kinesiophobia
  • Kinesiophobia [ Time Frame: 24 months ]
    Tampa Scale for Kinesiophobia
  • Self-efficacy [ Time Frame: 12 months ]
    General Self-efficacy Scale
  • Self-efficacy [ Time Frame: 24 months ]
    General Self-efficacy Scale
  • Depression and anxiety [ Time Frame: 12 months ]
    Patient Health Questionnaire-4
  • Depression and anxiety [ Time Frame: 24 months ]
    Patient Health Questionnaire-4
  • Loneliness [ Time Frame: 12 months ]
    Three-item Loneliness Scale
  • Loneliness [ Time Frame: 24 months ]
    Three-item Loneliness Scale
  • Ability to work [ Time Frame: 12 months ]
    Registerbased
  • Ability to work [ Time Frame: 24 months ]
    Registerbased
Original Secondary Outcome Measures
 (submitted: December 22, 2015)
  • Well-being [ Time Frame: 24 months ]
    World Health Organization-5
  • Work ability [ Time Frame: 12 months ]
    10-points Likert scale
  • Work ability [ Time Frame: 24 months ]
    10-points Likert scale
  • Pain [ Time Frame: 12 months ]
    Visual analogue scale
  • Pain [ Time Frame: 24 months ]
    Visual analogue scale
  • Interpersonal Problems [ Time Frame: 12 months ]
    Inventory of Interpersonal Problems-64
  • Interpersonal Problems [ Time Frame: 24 months ]
    Inventory of Interpersonal Problems-64
  • Physical capacity [ Time Frame: 12 months ]
    10-points Likert scale, 5 domains
  • Physical capacity [ Time Frame: 24 months ]
    10-points Likert scale, 5 domains
  • Kinesiophobia [ Time Frame: 12 months ]
    Tampa Scale for Kinesiophobia
  • Kinesiophobia [ Time Frame: 24 months ]
    Tampa Scale for Kinesiophobia
  • Self-efficacy [ Time Frame: 12 months ]
    General Self-efficacy Scale
  • Self-efficacy [ Time Frame: 24 months ]
    General Self-efficacy Scale
  • Depression and anxiety [ Time Frame: 12 months ]
    Patient Health Questionnaire-4
  • Depression and anxiety [ Time Frame: 24 months ]
    Patient Health Questionnaire-4
  • Loneliness [ Time Frame: 12 months ]
    Three-item Loneliness Scale
  • Loneliness [ Time Frame: 24 months ]
    Three-item Loneliness Scale
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title The Development Path
Official Title A Descriptive Study of Characteristics and Progression of Citizens Assigned to a Multidisciplinary Program Focusing on Moving Citizens From Unemployment and Social Security Benefits to Employment and Education
Brief Summary

The aim of this project is a research-based evaluation of a multidisciplinary program focusing on moving citizens from unemployment and social security benefits to employment and education in Sonderborg Municipality. The citizens who are assigned cannot readily enter the labor market or can get education through employment initiatives in the Job Centre in Sonderborg Municipality because of complex health-related troubles.

The project is designed to include a prospective observational study and a qualitative study using questionnaires, observations, interviews and informations about employment from the Sonderborg Municipality.

Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Probability Sample
Study Population Unemployed citizens with complex health-related problems assigned to a multidisciplinary program in Sønderborg Municipality
Condition Absenteeism
Intervention Behavioral: Multidisciplinary program
Coordinated multidisciplinary program
Study Groups/Cohorts Multidisciplinary program
Multidisciplinary program designed and administered by the Competence- and Integration Center in Sonderborg Municipality
Intervention: Behavioral: Multidisciplinary program
Publications * Andersen LN, Stochkendahl MJ, Roessler KK. A municipality-based vocational rehabilitation programme for occupationally marginalized citizens: a study protocol for a mixed methods study. BMC Health Serv Res. 2018 Jul 3;18(1):517. doi: 10.1186/s12913-018-3322-4.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: October 10, 2018)
146
Original Estimated Enrollment
 (submitted: December 22, 2015)
200
Actual Study Completion Date March 2018
Actual Primary Completion Date March 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • Assigned to a multidisciplinary program in Sonderborg Municipality (the Law on Active Employment §68 https://www.retsinformation.dk/forms/r0710.aspx?id=164698#Kap2 )

Exclusion Criteria:

  • Not able to communicate in Danish
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Denmark
Removed Location Countries  
 
Administrative Information
NCT Number NCT02641704
Other Study ID Numbers 14111-SDUpro
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Lotte Nygaard Andersen, University of Southern Denmark
Study Sponsor University of Southern Denmark
Collaborators Sonderborg Municipality
Investigators
Principal Investigator: Lotte Nygaard Andersen, PhD University of Southern Denmark
PRS Account University of Southern Denmark
Verification Date October 2018