Requirements and Functional Schedule as a Part of Painrehabilitation.
Primary Purpose
Chronic Pain
Status
Recruiting
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
Requirements and functional Schedule
No intervention
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Pain
Eligibility Criteria
Inclusion Criteria:
Chronic pain, has an employment
Exclusion Criteria:
no longer than 6 month of total sick-leave
Sites / Locations
- Katarina DanielssonRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Painrehabilitation + Demand and ability protocol
Painrehabilitation
Arm Description
Will receive pain-rehabilitation and the intervention ( an interview called Requirements and functional Schedule, with the patients employer and an occupational therapist)
Will receive pain-rehabilitation
Outcomes
Primary Outcome Measures
Absence from work (sickleave) measured with a question to the participants
Less absence from work
Absence from work (sickleave) measured with a question to the participants
Less absence from work
Secondary Outcome Measures
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
.
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
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.
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.
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.
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.
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.
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.
Changes in Work ability
Changes in work ability measured with the 7:th question in Work Ability Index questionnaire
Changes in Work ability
Changes in work ability measured with the 7:th question in Work Ability Index questionnaire
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).
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).
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05080062
Brief Title
Requirements and Functional Schedule as a Part of Painrehabilitation.
Official Title
Requirements and Functional Schedule- An Intervention to Use in Painrehabilitation, to Strengthen the Collaboration Between the Healthcare, Employers and Employees
Study Type
Interventional
2. Study Status
Record Verification Date
October 2021
Overall Recruitment Status
Recruiting
Study Start Date
June 20, 2019 (Actual)
Primary Completion Date
December 20, 2022 (Anticipated)
Study Completion Date
December 20, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Uppsala University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief 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.
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Pain
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
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)
Allocation
Non-Randomized
Enrollment
150 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Painrehabilitation + Demand and ability protocol
Arm Type
Experimental
Arm Description
Will receive pain-rehabilitation and the intervention ( an interview called Requirements and functional Schedule, with the patients employer and an occupational therapist)
Arm Title
Painrehabilitation
Arm Type
Active Comparator
Arm Description
Will receive pain-rehabilitation
Intervention Type
Behavioral
Intervention Name(s)
Requirements and functional Schedule
Intervention Description
An interview with the employee and the employer where the occupational worker is leading the interview and a pain rehabilitation-program
Intervention Type
Behavioral
Intervention Name(s)
No intervention
Intervention Description
a pain rehabilitation-program
Primary Outcome Measure Information:
Title
Absence from work (sickleave) measured with a question to the participants
Description
Less absence from work
Time Frame
Changes from baseline in absence from work to the end of the rehab program (average 4month)
Title
Absence from work (sickleave) measured with a question to the participants
Description
Less absence from work
Time Frame
Changes from baseline in absence from work through study completion (average 1,5 years)
Secondary Outcome Measure Information:
Title
Changes in EuroQol 5-dimensions questionnaire (EQ-5D)
Description
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
.
Time Frame
Change from baseline in EuroQol 5-dimensions through study completion (average 1,5 years)
Title
Changes in EuroQol 5-dimensions
Description
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
Time Frame
Change from baseline in EuroQol 5-dimensions to the end of the rehab program (average foru month)
Title
Changes in Anxiety and depression
Description
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.
Time Frame
Change from baseline in anxiety and depression through study completion (average 1,5 years)hs)
Title
Changes in Anxiety and depression
Description
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.
Time Frame
Change from baseline in anxiety and depression to the end of the rehab program (average four month)
Title
Changes in sleep
Description
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.
Time Frame
Change from baseline in Insomnia Severity Index to the end of the rehab program (average four month)
Title
Changes in sleep
Description
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.
Time Frame
Change from baseline in Insomnia Severity Index through study completion (average 1,5 years)
Title
Changes in Life satisfaction
Description
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.
Time Frame
Change from baseline in Life Satisfaction Questionnaire to the end of the rehab program (average four month)
Title
Changes in Life satisfaction
Description
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.
Time Frame
Change from baseline in Life Satisfaction Questionnaire through study completion (average 1,5 years)
Title
Changes in Work ability
Description
Changes in work ability measured with the 7:th question in Work Ability Index questionnaire
Time Frame
Change from baseline in Work ability to the end of the rehab program (average four month)
Title
Changes in Work ability
Description
Changes in work ability measured with the 7:th question in Work Ability Index questionnaire
Time Frame
Change from baseline in Work ability through study completion (average 1,5 years)
Title
Changes in health-related quality of life
Description
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).
Time Frame
Change from baseline in RAND-36 to the end of the rehab program (average four month)
Title
Changes in health-related quality of life
Description
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).
Time Frame
Change from baseline in RAND-36 through study completion (average 1,5 years)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Chronic pain, has an employment
Exclusion Criteria:
no longer than 6 month of total sick-leave
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Katarina Danielsson, MD
Phone
000186110000
Ext
000186110000
Email
katarina.danielsson@akademiska.se
First Name & Middle Initial & Last Name or Official Title & Degree
Katarina Danielsson
Phone
000186110000
Ext
000186110000
Email
katarina.danielsson@akademiska.se
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Therese Hellman, PhD
Organizational Affiliation
Uppsala University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Katarina Danielsson
City
Uppsala
ZIP/Postal Code
75239
Country
Sweden
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Katarina Danielsson
Phone
000186110000
Ext
000186110000
Email
katarina.danielsson@akademiska.se
12. IPD Sharing Statement
Plan to Share IPD
No
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