Evaluation of a Collaborative Intervention to Promote Employer Contact and RTW Among People With CMD or Chronic Pain
Primary Purpose
Pain, Chronic, Mental Disorder
Status
Recruiting
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
Demand and ability protocol
Collaborative interventions as usual
Sponsored by
About this trial
This is an interventional treatment trial for Pain, Chronic
Eligibility Criteria
Inclusion Criteria:
- have a diagnosis of CMD and/or chronic pain
- have a job
- be on full-time or part time sick leave
- accept the manager's involvement.
Exclusion Criteria:
- been on full-time sick leave for more than 6 months before the first contact with REKO
Sites / Locations
- Region UppsalaRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Other
Arm Label
Experimental
Active comparator
Arm Description
The rehabilitation coordinators are trained in the intervention (0,5 day).
Participants in the experimental arm will be matched with controls from the Micro Data for the Analysis of Social Insurance register (MiDAS) from the Social Insurance Agency, Sweden.
Outcomes
Primary Outcome Measures
Sick leave
The total number of days on sick leave due to CMDs or chronic pain during the 12 month follow-up period
Secondary Outcome Measures
Full Information
NCT ID
NCT05216861
First Posted
January 17, 2022
Last Updated
April 26, 2023
Sponsor
Uppsala University
Collaborators
Uppsala University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT05216861
Brief Title
Evaluation of a Collaborative Intervention to Promote Employer Contact and RTW Among People With CMD or Chronic Pain
Official Title
Evaluation of a Collaborative Intervention to Promote Early Employer Contact and Return to Work Among People With Common Mental Disorders or Long-term Pain
Study Type
Interventional
2. Study Status
Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 15, 2022 (Actual)
Primary Completion Date
September 30, 2024 (Anticipated)
Study Completion Date
December 21, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Uppsala University
Collaborators
Uppsala University Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The overall aim of this cluster ranomized controlled trial is to investigate whether an intervention for collaboration between patient with CMD or chronic pain and employer (the Demand and Ability Protocol) can contribute to reduced sick leave and to increased health, work ability and trust in the managers. The intervention is delivered by rehabiliation coordinators at primary health care centres.
Detailed Description
The overall aim of this cluster ranomized controlled trial is to investigate whether an intervention for collaboration between patient with CMD or chronic pain and employer (the Demand and Ability Protocol) can contribute to reduced sick leave and to increased health, work ability and trust in the managers. The intervention is delivered by rehabilitation coordinators at primary health care centres.
Furthermore, the aim is to identify hindering and facilitating factors for feasibility, usability and implementation of the Demand and Ability Protocol intervention (DAP) in primary health care.
Research questions:
What is the effect of DAP for patients regarding sick leave, health, work ability, and trust in the manager compared to matched controls who do not recieve DAP?
How do patients and managers experience their participation in the intervention and how do they experience the usability of the DAP?
What facilitating and hindering factors exist for the introduction and implementation of DAP in primary health care, and how do rehabilitation coordinators (REKO) and medical doctors experience the feasibility and usability of the intervention?
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Chronic, Mental Disorder
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Non-Randomized
Enrollment
120 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Experimental
Arm Type
Experimental
Arm Description
The rehabilitation coordinators are trained in the intervention (0,5 day).
Arm Title
Active comparator
Arm Type
Other
Arm Description
Participants in the experimental arm will be matched with controls from the Micro Data for the Analysis of Social Insurance register (MiDAS) from the Social Insurance Agency, Sweden.
Intervention Type
Other
Intervention Name(s)
Demand and ability protocol
Intervention Description
The intervention consists of a structured conversation between the patient and his immediate manager under the guidance of licensed medical staff (in this case REKO) with knowledge of the requirements of the patient's work and his/her current functional ability. The intervention takes about 90 minutes excluding preparation time for REKO.
DAP consider the following domains; 1) mental and cognitive ability, 2) basic skills and social ability, 3) tolerance for physical conditions, 4) ability to work dynamically, 5) ability to work statically and 6) to be able to work certain times.
Based on the above domains, a structured review is made of the balance between requirements and function in current work in order to identify possible adaptations and measures at the workplace. During the intervention, the work requirements and the patient's function/ability are identified on a three-point scale and in domains where there is thus an imbalance adjustments or changed tasks are identified.
Intervention Type
Other
Intervention Name(s)
Collaborative interventions as usual
Intervention Description
The rehabilitation coordinator conduct collaborative interventions as usual with patient and employer. This might be through phone calls are unstructured meetings.
Primary Outcome Measure Information:
Title
Sick leave
Description
The total number of days on sick leave due to CMDs or chronic pain during the 12 month follow-up period
Time Frame
From baseline until 12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
have a diagnosis of CMD and/or chronic pain
have a job
be on full-time or part time sick leave
accept the manager's involvement.
Exclusion Criteria:
been on full-time sick leave for more than 6 months before the first contact with REKO
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Therese Hellman, PhD
Phone
+46706539504
Email
therese.hellman@medsci.uu.se
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Therese Hellman, PhD
Organizational Affiliation
Uppsala University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Region Uppsala
City
Uppsala
State/Province
Uppsala Lan
ZIP/Postal Code
75652
Country
Sweden
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Therese Hellman, PhD
Phone
+46706539504
Email
therese.hellman@medsci.uu.se
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Evaluation of a Collaborative Intervention to Promote Employer Contact and RTW Among People With CMD or Chronic Pain
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