Official title: Requirements and Functional Schedule- An Intervention to Use in Painrehabilitation, to Strengthen the Collaboration Between the Healthcare, Employers and Employees

Requirements and functional Schedule also calen Demand Ability Protocol (DAP) is an intervention that has been tested and found useful in occupational health service. The intervention aims to strengthen the collaboration between Health care, employers and employee. The intervention is based on a structured interview about the employers demands at work. This intervention (DAP) will in the present study be evaluated in pain rehabilitation both qualitatively and quantitatively.

Read the detailed description

Description of the intervention: Demand and Ability Protocol Demand and Ability Protocol (DAP) is an intervention linked to the International Classification of Functioning, Disability and Health, and is based on the Dutch Functional Ability List and knowledge about disability in working life (Brouwer et al, 2002). The intervention has been further developed and modified in Norway and is primarily used in occupational health care services for collaboration between an employee and his or her immediate manager (Engbers \& Furuland, 2006).

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 the rating of requirements and function/ability does not match, there is thus an imbalance, and here adjustments or changed tasks may be relevant to consider increasing work ability and reducing sick leave. The intervention concludes with a summary of the situation and joint development of appropriate measures/adaptations to promote the patient's RTW. This is documented on a form, which is signed by both the patient and the manage

Conditions: Chronic Pain
Being tested: Requirements and functional Schedule, No intervention
Medical subject headings: Chronic Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Requirements and functional ScheduleBehavioural
An interview with the employee and the employer where the occupational worker is leading the interview and a pain rehabilitation-program
No interventionBehavioural
a pain rehabilitation-program

Study groups in NCT05080062
Study group	Role	What they receive
Painrehabilitation + Demand and ability protocol	Experimental	Will receive pain-rehabilitation and the intervention ( an interview called Requirements and functional Schedule, with the patients employer and an occupational therapist) Receives: Behavioral: Requirements and functional Schedule
Painrehabilitation	Active comparator	Will receive pain-rehabilitation Receives: Behavioral: No intervention

What is being measured

The primary outcome is the main question the study is designed to answer.

Absence from work (sickleave) measured with a question to the participants
Less absence from work
Measured: Changes from baseline in absence from work to the end of the rehab program (average 4month)
Absence from work (sickleave) measured with a question to the participants
Less absence from work
Measured: Changes from baseline in absence from work through study completion (average 1,5 years)

Secondary outcomes (12)

Changes in EuroQol 5-dimensions questionnaire (EQ-5D)
Changes in quality of Life measured with the EuroQol 5-dimensions. Each combination of values has an idex value where 1 is the best quality of life. The questionnaire also includes a visual analog scale (VAS), which records the respondent's self-rated health status on a graduated (0-100) scale, with higher scores for higher qulaity of life
.
Measured: Change from baseline in EuroQol 5-dimensions through study completion (average 1,5 years)
Changes in EuroQol 5-dimensions
Changes in quality of Life measured with the EuroQol 5-dimensions. Each combination of values has an idex value where 1 is the best quality of life. The questionnaire also includes a visual analog scale (VAS), which records the respondent's self-rated health status on a graduated (0-100) scale, with higher scores for higher qulaity of life
Measured: Change from baseline in EuroQol 5-dimensions to the end of the rehab program (average foru month)
Changes in Anxiety and depression
Changes in Hospital Anxiety and Depression Scale (HADS). The scale icludes two subscales one focusing on anxiety symptoms and one on depressive symptoms. The minimum value is 0 and the maximum value is 21 for each subscale. Higher scores means worse outcome.
Measured: Change from baseline in anxiety and depression through study completion (average 1,5 years)hs)
Changes in Anxiety and depression
Changes in Hospital Anxiety and Depression Scale (HADS). The scale icludes two subscales one focusing on anxiety symptoms and one on depressive symptoms. The minimum value is 0 and the maximum value is 21 for each subscale. Higher scores means worse outcome.
Measured: Change from baseline in anxiety and depression to the end of the rehab program (average four month)
Changes in sleep
Changes in Insomnia measured with Insomnia Severity Index (ISI). The minimum value is 0 and the maximum value is 28. Higher scores indicates a worse outcome.
Measured: Change from baseline in Insomnia Severity Index to the end of the rehab program (average four month)
Changes in sleep
Changes in sleep measured with Insomnia Severity Index (ISI). The minimum value is 0 and the maximum value is 28. Higher scores indicates a worse outcome.
Measured: Change from baseline in Insomnia Severity Index through study completion (average 1,5 years)
Changes in Life satisfaction
Changes in Life Satisfaction measured with Life Satisfaction Questionnaire (Li-Sat-11). Minimum score at 11 and maximum score at 66. Higher scores indicate a greater level of perceived satisfaction.
Measured: Change from baseline in Life Satisfaction Questionnaire to the end of the rehab program (average four month)
Changes in Life satisfaction
Changes in Life Satisfaction measured with Life Satisfaction Questionnaire (Li-Sat-11). Minimum score at 11 and maximum score at 66. Higher scores indicate a greater level of perceived satisfaction.
Measured: Change from baseline in Life Satisfaction Questionnaire through study completion (average 1,5 years)
Changes in Work ability
Changes in work ability measured with the 7:th question in Work Ability Index questionnaire
Measured: Change from baseline in Work ability to the end of the rehab program (average four month)
Changes in Work ability
Changes in work ability measured with the 7:th question in Work Ability Index questionnaire
Measured: Change from baseline in Work ability through study completion (average 1,5 years)
Changes in health-related quality of life
Changes in health-related quality of life measured with RAND-36. The RAND-36 consists of 36 items grouped into eight multi-item scales: physical functioning (PF), role-functioning/physical (RP), pain (P), general health (GH), energy/fatigue (EF), social functioning (SF), role-functioning/emotional (RE), and emotional well-being (EW). An additional item asks about health change (HC) in the past year. Scale scores are summed and transformed into scales ranging from 0 (worst possible health state) to 100 (best possible state).
Measured: Change from baseline in RAND-36 to the end of the rehab program (average four month)
Changes in health-related quality of life
Changes in health-related quality of life measured with RAND-36. The RAND-36 consists of 36 items grouped into eight multi-item scales: physical functioning (PF), role-functioning/physical (RP), pain (P), general health (GH), energy/fatigue (EF), social functioning (SF), role-functioning/emotional (RE), and emotional well-being (EW). An additional item asks about health change (HC) in the past year. Scale scores are summed and transformed into scales ranging from 0 (worst possible health state) to 100 (best possible state).
Measured: Change from baseline in RAND-36 through study completion (average 1,5 years)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

20 Jun 201920 Dec 2023

First posted15 Oct 2021
Study start20 Jun 2019
Primary completion20 Dec 2022 (estimated)
Study completion20 Dec 2023 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Chronic PainStudies 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: Single group
Model description: 50 patients who are in painrehabilitation will also receive the intervention. The control Group will be based on patients from 2017 and 2018 who has underwent rehabilitation. This data will be extracted from the National register of pain rehabilitation in Sweden.
Masking: None (open label)
Enrolment: 150 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05080062
Sponsor's protocol ID: 2019/01755
Other IDs: 2019
Status last verified: Oct 2021
First submitted: 16 Jul 2019
Last updated: 8 Nov 2021
Results posted: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Want to know more?

Katarina Danielsson, MD

000186110000 ext. 000186110000

katarina.danielsson@akademiska.se

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Chronic Pain trials

Study at a glance

From the registry record, last updated by the sponsor on 8 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Requirements and Functional Schedule- An Intervention to Use in Painrehabilitation, to Strengthen the Collaboration Between the Healthcare, Employers and Employees
ClinicalTrials.gov ID: NCT05080062
Acronym / sponsor ID: 2019/01755
Conditions: Chronic Pain
Study type: Interventional
Recruitment status: Unknown status
Enrolment: 150 participants (estimated)
Lead sponsor: Uppsala UniversityUniversity, hospital or other
Study start: 20 Jun 2019 (actual)
Primary completion: 20 Dec 2022 (estimated)
Study completion: 20 Dec 2023 (estimated)
First posted: 15 Oct 2021 (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.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Single group
Masking: None (open label)
Number of arms: 2
Model description: 50 patients who are in painrehabilitation will also receive the intervention. The control Group will be based on patients from 2017 and 2018 who has underwent rehabilitation. This data will be extracted from the National register of pain rehabilitation in Sweden.

Arm	Type	Receives
Painrehabilitation + Demand and ability protocol	Experimental	Behavioral: Requirements and functional ScheduleWill receive pain-rehabilitation and the intervention ( an interview called Requirements and functional Schedule, with the patients employer and an occupational therapist)
Painrehabilitation	Active comparator	Behavioral: No interventionWill receive pain-rehabilitation

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (1 listed)

Chronic pain, has an employment

Key exclusion criteria (1 listed)

no longer than 6 month of total sick-leave

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
Requirements and functional ScheduleAn interview with the employee and the employer where the occupational worker is leading the interview and a pain rehabilitation-program	Behavioural	Painrehabilitation + Demand and ability protocol
No interventiona pain rehabilitation-program	Behavioural	Painrehabilitation

Primary outcome

Absence from work (sickleave) measured with a question to the participants
Time frame: Changes from baseline in absence from work to the end of the rehab program (average 4month)
Less absence from work
Absence from work (sickleave) measured with a question to the participants
Time frame: Changes from baseline in absence from work through study completion (average 1,5 years)
Less absence from work

12 secondary outcomes

Changes in EuroQol 5-dimensions questionnaire (EQ-5D)
Time frame: Change from baseline in EuroQol 5-dimensions through study completion (average 1,5 years)
Changes in EuroQol 5-dimensions
Time frame: Change from baseline in EuroQol 5-dimensions to the end of the rehab program (average foru month)
Changes in Anxiety and depression
Time frame: Change from baseline in anxiety and depression through study completion (average 1,5 years)hs)
Changes in Anxiety and depression
Time frame: Change from baseline in anxiety and depression to the end of the rehab program (average four month)
Changes in sleep
Time frame: Change from baseline in Insomnia Severity Index to the end of the rehab program (average four month)
Changes in sleep
Time frame: Change from baseline in Insomnia Severity Index through study completion (average 1,5 years)
Changes in Life satisfaction
Time frame: Change from baseline in Life Satisfaction Questionnaire to the end of the rehab program (average four month)
Changes in Life satisfaction
Time frame: Change from baseline in Life Satisfaction Questionnaire through study completion (average 1,5 years)
Changes in Work ability
Time frame: Change from baseline in Work ability to the end of the rehab program (average four month)
Changes in Work ability
Time frame: Change from baseline in Work ability through study completion (average 1,5 years)
Changes in health-related quality of life
Time frame: Change from baseline in RAND-36 to the end of the rehab program (average four month)
Changes in health-related quality of life
Time frame: Change from baseline in RAND-36 through study completion (average 1,5 years)

Results and safety

Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 8 Nov 2021.
Individual participant dataSharing planned: No

Related trials for Chronic Pain

Recruiting
Empowered Relief® for Cancer Survivors With Chronic Pain
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RecruitingObservational study
Pain Phenotypes in Individuals With Multiple Sclerosis
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Not yet recruiting
Effect of Lumbar Stabilization Exercises With and Without YTWL (Scapular Stabilization Exercises) on Reducing Chronic Low Back Pain and Related Disability. A Randomized Clinical Trial,
Chronic Non Specific Mechanical Low Back Pain
Not yet recruiting
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Chronic Low-back Pain (cLBP), High-Impact Chronic Pain (HICP)
Not yet recruiting
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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.

Katarina Danielsson, MD contact

000186110000 ext. 000186110000

katarina.danielsson@akademiska.se

Katarina Danielsson contact

000186110000 ext. 000186110000

katarina.danielsson@akademiska.se

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 Requirements and functional Schedule in people with Chronic Pain, 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 1 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 Nov 2021. 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 Katarina Danielsson, MD (000186110000 ext. 000186110000, katarina.danielsson@akademiska.se), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Absence from work (sickleave) measured with a question to the participants (time frame: Changes from baseline in absence from work to the end of the rehab program (average 4month)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05080062.

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 Nov 2021.