Pain, ChronicNCT05216861
Evaluation of a Collaborative Intervention to Promote Employer Contact and RTW Among People With CMD or Chronic Pain
A study testing Demand and ability protocol and Collaborative interventions as usual in people with Pain, Chronic and Mental Disorder, run by Uppsala University at 1 site in Sweden.
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Pain, Chronic, Mental Disorder
- What is being tested?
- Demand and ability protocol and Collaborative interventions as usual
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteSweden
- Study dates
- 15 Feb 2022to 21 Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- been on full-time sick leave for more than 6 months before the first contact with REKO
Trial locations and contacts
1 site in 1 country.
Sweden1 site, 1 recruiting
- Recruiting
Region Uppsala
Uppsala, Uppsala County, 75652
Therese Hellman, PhD, +46706539504, therese.hellman@medsci.uu.se
About this study
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
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:
- 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?
- Conditions
- Pain, Chronic, Mental Disorder
- Being tested
- Demand and ability protocol, Collaborative interventions as usual
- Medical subject headings
- Chronic Pain, Mental Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Demand and ability protocolOther
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 usualOther
The rehabilitation coordinator conduct collaborative interventions as usual with patient and employer. This might be through phone calls are unstructured meetings.
| Study group | Role | What they receive |
|---|---|---|
| Experimental | Experimental | The rehabilitation coordinators are trained in the intervention (0,5 day). Receives: Other: Demand and ability protocol |
| Active comparator | Other | 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. Receives: Other: Collaborative interventions as usual |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sick leave
The total number of days on sick leave due to CMDs or chronic pain during the 12 month follow-up period
Measured: From baseline until 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2022
- Study start15 Feb 2022
- Primary completion31 Dec 2024 (estimated)
- Study completion21 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pain, ChronicStudies of the same condition, open and under way.
- More trials run by Uppsala UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Uppsala University
- Sponsor type
- University, hospital or other
- Collaborators
- Uppsala University Hospital
- Responsible party
- Principal investigator, Therese Hellman, Uppsala University
- Investigators
- Therese Hellman, PhD, Principal investigator, Uppsala University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05216861
- Sponsor's protocol ID
- RFR-968570
- Status last verified
- May 2024
- First submitted
- 17 Jan 2022
- Last updated
- 8 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05216861
- Acronym / sponsor ID
- RFR-968570
- Conditions
- Pain, Chronic, Mental Disorder
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Uppsala UniversityUniversity, hospital or other
- Collaborators
- Uppsala University Hospital
- Study start
- 15 Feb 2022 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 21 Dec 2025 (estimated)
- First posted
- 1 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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?
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental | Experimental | Other: Demand and ability protocolThe rehabilitation coordinators are trained in the intervention (0,5 day). |
| Active comparator | Other | Other: Collaborative interventions as usualParticipants 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (1 listed)
- been on full-time sick leave for more than 6 months before the first contact with REKO
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Demand and ability protocolThe 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. | Other | Experimental |
| Collaborative interventions as usualThe rehabilitation coordinator conduct collaborative interventions as usual with patient and employer. This might be through phone calls are unstructured meetings. | Other | Active comparator |
Primary outcome
Sick leave
Time frame: From baseline until 12 months
The total number of days on sick leave due to CMDs or chronic pain during the 12 month follow-up period
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Therese Hellman, PhD principal investigator
Uppsala University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Demand and ability protocol and Collaborative interventions as usual in people with Pain, Chronic and Mental Disorder, run by Uppsala University at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Therese Hellman, PhD (+46706539504, therese.hellman@medsci.uu.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sick leave (time frame: From baseline until 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 May 2024.