Joint Coordination to Facilitate the Transition From Sick... | NCT03348410

Studies
Joint Coordination to Facilitate the Transition From Sick Leave to Employment

NCT03348410

Sponsor

Uppsala University

Status

Completed

Last Update Posted

Oct 19, 2020Actual

Enrollment

193Actual

Phase

Not Applicable

Conditions

Long Term Sick Leave
Absent-mindedness

Interventions

Motivational interviewing

Countries

Sweden

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2020

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 14, 2017Actual

Primary Completion Date

Nov 14, 2019Actual

Completion Date

Dec 14, 2019Actual

First Submitted Date

Nov 16, 2017

First Submission Date that Met QC Criteria

Nov 16, 2017

First Posted Date

Nov 20, 2017Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 16, 2020

Last Update Posted Date

Oct 19, 2020Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

GESAM is a randomized controlled intervention study that addressed women and men on long-term sick leave in Uppsala County. Participants which are on sick leave due to mental illness and/or pain and were expected to reach the time limit within the in health insurance will be offered to participate in an intervention.

Those how give informed consent will be randomly assigned one of the following groups: 1) informing and motivating intervention with insurance officer 2) control group. The main purpose of the study is to facilitate the return to work (preventing a return to the public health insurance) during the project period.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

193Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Intervention	Experimental	Motivational interviewing	Behavioral: Motivational interviewing
Control	No Intervention	Control group

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Motivational interviewing	Behavioral	Motivational interviewing with insurance officer	Intervention

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Return to work (RTW)	Return to work measured as time to participation in the labor force	One year

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

On sick leave
Risk of losing sick leave compensation

Exclusion Criteria:

Major mental illness (schizophrenia, bipolar disorder type I, severe social dysfunction/personality disorder)
Cancer disease

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

64 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Ingrid Anderzén, PHD	Uppsala University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Uppsala university		Uppsala		SE-75122	Sweden

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D062405	Motivational Interviewing

Ancestor Terms

ID	Term
D037001	Directive Counseling
D003376	Counseling
D008605	Mental Health Services
D004191	Behavioral Disciplines and Activities

Browse Leaves

Not provided

Browse Branches

Not provided