Requirements and Functional Schedule as a Part of Painrehabilitation.

Chronic Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05080062
• Other study ID #: 2019/01755
• Status: Recruiting
• Phase: N/A
• Start date: June 20, 2019
• Est. completion date: December 20, 2023

Study information

• Verified date: October 2021
• Source: Uppsala University
• Contact: Katarina Danielsson, MD
• Phone: 000186110000
• Email: katarina.danielsson[@]akademiska.se
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: December 20, 2023
• Est. primary completion date: December 20, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

Chronic pain, has an employment Exclusion Criteria: no longer than 6 month of total sick-leave

Related Conditions & MeSH terms

• Chronic Pain

Intervention

Behavioral:
• Requirements and functional Schedule
An interview with the employee and the employer where the occupational worker is leading the interview and a pain rehabilitation-program
• No intervention
a pain rehabilitation-program

Locations

Country	Name	City	State
Sweden	Katarina Danielsson	Uppsala

Sponsors (1)

Lead Sponsor	Collaborator
Uppsala University

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Absence from work (sickleave) measured with a question to the participants	Less absence from work	Changes from baseline in absence from work to the end of the rehab program (average 4month)
Primary	Absence from work (sickleave) measured with a question to the participants	Less absence from work	Changes from baseline in absence from work through study completion (average 1,5 years)
Secondary	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; .	Change from baseline in EuroQol 5-dimensions through study completion (average 1,5 years)
Secondary	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	Change from baseline in EuroQol 5-dimensions to the end of the rehab program (average foru month)
Secondary	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.	Change from baseline in anxiety and depression through study completion (average 1,5 years)hs)
Secondary	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.	Change from baseline in anxiety and depression to the end of the rehab program (average four month)
Secondary	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.	Change from baseline in Insomnia Severity Index to the end of the rehab program (average four month)
Secondary	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.	Change from baseline in Insomnia Severity Index through study completion (average 1,5 years)
Secondary	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.	Change from baseline in Life Satisfaction Questionnaire to the end of the rehab program (average four month)
Secondary	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.	Change from baseline in Life Satisfaction Questionnaire through study completion (average 1,5 years)
Secondary	Changes in Work ability	Changes in work ability measured with the 7:th question in Work Ability Index questionnaire	Change from baseline in Work ability to the end of the rehab program (average four month)
Secondary	Changes in Work ability	Changes in work ability measured with the 7:th question in Work Ability Index questionnaire	Change from baseline in Work ability through study completion (average 1,5 years)
Secondary	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).	Change from baseline in RAND-36 to the end of the rehab program (average four month)
Secondary	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).	Change from baseline in RAND-36 through study completion (average 1,5 years)