Clinical trial NCT02136056: Effects of a Self-management Course for Adults on Sick-leave
Official title: Effects of a Self-management Course for Adults on Sick-leave; Outcomes in Registry Based Measures of Return to Work and Questionnaire Based Measures of Well-being and Quality of Life
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Workers on Sick-leave, Insured by The Danish Welfare State
Keywords: Sick-leave
Return to work
Self-management
Self-efficacy
Quality of Life and Well-being
Motivation
Lead sponsor: University of Aarhus
Sponsor class: OTHER
Collaborators: name: Aarhus University Hospital
name: VIVE - The Danish Center for Social Science Research
First posted: 2014-05-12
Enrollment: 600
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of the current study is to determine the efficacy of a self-management course for workers on sick-leave as an add-on to standard rehabilitation care and follow-up (treatment as usual). Outcomes are registry based measures of return to work, and questionnaire based measures of well-being and quality of life.

We thus, hypothesize that the program will improve workers return to work rates and self-reported/psychological well-being.

Detailed description: The intervention course is a Danish adaptation of The Chronic Disease Self-Management Program (CDSMP), tailored towards workers on sick-leave. The original program has been developed by The Stanford Patient Education Research Center. The translation and adaptation has been conducted by The Danish Committee for Health Education.

Previous studies have examined the program with respect to specific chronic diseases (e.g., Arthritis), quality of life, well-being and health-care utilization, though non-otherwise specified workers on sick-leave and return work have not been examined before.

The framework of CDSMP is social-cognitive learning theory in which self-efficacy plays a central role.

Eligibility criteria: Inclusion Criteria:

* Insured persons who receive sick-leave compensation from the Danish State
* Persons who are listed as sick from a job
* Persons who have been categorized as "2 - risk" or "3 - chronic" case by the job-center
* The health problem reflects a chronic or a long-term condition
* The person acknowledges a chronic or long-term condition
* The person wants to work with his or her condition
* The person wants to return to work
* The person volunteers to participate

Exclusion Criteria:

* Persons who are listed sick for more than 16 weeks
* Persons who are categorized as "1 - easy" by the job-center
* The person does not understand or speak danish
* History or signs of aggressive behavior and violence

Primary outcomes:
measure: Return to work, duration
timeFrame: Weekly from baseline till 1 year follow-up
measure: Well-being and Quality of life
timeFrame: up to 5 month follow-up
Secondary outcomes:
measure: Common mental disorders
timeFrame: Baseline, post-intervention and 4,5 month follow-up
measure: Disease self-efficacy scale
timeFrame: Baseline, post-intervention and 4,5 month follow-up
measure: Self-regulation (return to work)
timeFrame: Baseline, post-intervention and 4,5 month follow-up
measure: Self-management scale
timeFrame: Baseline, post-intervention and 4,5 month follow-up
measure: Illness Perception questionnaire
timeFrame: Baseline, post-intervention and 4,5 month follow-up
Other outcomes:
measure: Health-care utilization
timeFrame: Baseline, post-intervention and 4,5 month follow-up
measure: Medicine consumption
timeFrame: Baseline, post-intervention and 4,5 month follow-up
measure: Adherence to treatment
timeFrame: Baseline, post-intervention and 4,5 month follow-up
measure: Common symptoms
timeFrame: Baseline, post-intervention and 4.5 month follow-up
measure: Decisional Balance (return to work)
timeFrame: Baseline, post-intervention and 4,5 month follow-up
measure: Return to work expectations
timeFrame: Baseline, post-intervention and 4,5 month follow-up
Locations:
city: Copenhagen
country: Denmark
facility: The Danish Comitee for Health Education
Study officials:
affiliation: Aarhus University and Aarhus University Hospital
name: Martin H Olesen, PhD
role: STUDY_DIRECTOR
affiliation: VIVE - The Danish Center for Social Science Research
name: Jan Høgelund, PhD
role: STUDY_CHAIR
affiliation: University of Aarhus
name: Mimi Y Mehlsen, PhD
role: PRINCIPAL_INVESTIGATOR
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