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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05216861
Other study ID # RFR-968570
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date February 15, 2022
Est. completion date December 21, 2025

Study information

Verified date May 2024
Source Uppsala University
Contact Therese Hellman, PhD
Phone +46706539504
Email therese.hellman@medsci.uu.se
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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: 1. 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? 2. How do patients and managers experience their participation in the intervention and how do they experience the usability of the DAP? 3. 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?


Recruitment information / eligibility

Status Recruiting
Enrollment 120
Est. completion date December 21, 2025
Est. primary completion date December 31, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years to 65 Years
Eligibility 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

Study Design


Intervention

Other:
Demand and ability protocol
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.
Collaborative interventions as usual
The rehabilitation coordinator conduct collaborative interventions as usual with patient and employer. This might be through phone calls are unstructured meetings.

Locations

Country Name City State
Sweden Region Uppsala Uppsala Uppsala Lan

Sponsors (2)

Lead Sponsor Collaborator
Uppsala University Uppsala University Hospital

Country where clinical trial is conducted

Sweden, 

Outcome

Type Measure Description Time frame Safety issue
Primary Sick leave The total number of days on sick leave due to CMDs or chronic pain during the 12 month follow-up period From baseline until 12 months
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