CClinicalTrials.gg
RecruitingNCT05216861Updated May 8, 2024

Evaluation of a Collaborative Intervention to Promote Employer Contact and RTW Among People With CMD or Chronic Pain

An interventional study of Demand and ability protocol and Collaborative interventions as usual in Pain, Chronic and Mental Disorder, sponsored by Uppsala University. Recruiting at 1 site in Sweden. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2024-05-08.

Sponsored by Uppsala University · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Dec 2024, 1 year 9 months ago, but the record still lists the study as recruiting.
  • Started Feb 2022; still recruiting 4 years 7 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
120
Allocation
Non-randomized
Ages
18 Years to 65 Years
Sex
All
01

Study 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.

Read the 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:

  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?
02

Conditions studied

  • Pain, Chronic
  • Mental Disorder
03

In context

Chronic Pain

2,930 studies on the registry are indexed under Chronic Pain; 701 are open to participants now.

This study's planned enrollment of 120 is above the median of 60 across 2,161 interventional studies indexed under Chronic Pain.

Browse Chronic Pain studies →

Lead sponsor

Uppsala University is the lead sponsor of 381 studies on the registry; 84 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

Exclusion Criteria:

  • been on full-time sick leave for more than 6 months before the first contact with REKO
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
120 participants (estimated)

Study arms

  • Experimental
    Experimental

    The rehabilitation coordinators are trained in the intervention (0,5 day).

    Other: Demand and ability protocol

  • Other
    Active comparator

    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.

    Other: Collaborative interventions as usual

Interventions

  • OtherDemand 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.

  • OtherCollaborative interventions as usual

    The rehabilitation coordinator conduct collaborative interventions as usual with patient and employer. This might be through phone calls are unstructured meetings.

06

What researchers measure

Primary outcomes

  1. Sick leave

    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

07

Study locations

1 of 1 sites recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 8, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05216861
Lead sponsor
Uppsala University
Collaborators
Uppsala University Hospital
Responsible party
Therese Hellman (PhD, Associate professor, Uppsala University) — Principal investigator
First posted
Feb 1, 2022
Start date
Feb 15, 2022
Primary completion
Dec 31, 2024 (estimated)
Completion
Dec 21, 2025 (estimated)
Last update
May 8, 2024

Study contacts

Therese Hellman, PhD
Contact
therese.hellman@medsci.uu.se
+46706539504
Therese Hellman, PhD
principal investigator · Uppsala University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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