- ICH GCP
- Registr klinických studií v USA
- Klinická studie NCT05080062
Requirements and Functional Schedule as a Part of Painrehabilitation.
Requirements and Functional Schedule- An Intervention to Use in Painrehabilitation, to Strengthen the Collaboration Between the Healthcare, Employers and Employees
Přehled studie
Postavení
Podmínky
Intervence / Léčba
Detailní popis
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
Typ studie
Zápis (Očekávaný)
Fáze
- Nelze použít
Kontakty a umístění
Studijní kontakt
- Jméno: Katarina Danielsson, MD
- Telefonní číslo: 000186110000 000186110000
- E-mail: katarina.danielsson@akademiska.se
Studijní záloha kontaktů
- Jméno: Katarina Danielsson
- Telefonní číslo: 000186110000 000186110000
- E-mail: katarina.danielsson@akademiska.se
Studijní místa
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Uppsala, Švédsko, 75239
- Nábor
- Katarina Danielsson
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Kontakt:
- Katarina Danielsson
- Telefonní číslo: 000186110000 000186110000
- E-mail: katarina.danielsson@akademiska.se
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Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
Přijímá zdravé dobrovolníky
Pohlaví způsobilá ke studiu
Popis
Inclusion Criteria:
Chronic pain, has an employment
Exclusion Criteria:
no longer than 6 month of total sick-leave
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Léčba
- Přidělení: Nerandomizované
- Intervenční model: Přiřazení jedné skupiny
- Maskování: Žádné (otevřený štítek)
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
---|---|
Experimentální: Painrehabilitation + Demand and ability protocol
Will receive pain-rehabilitation and the intervention ( an interview called Requirements and functional Schedule, with the patients employer and an occupational therapist)
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An interview with the employee and the employer where the occupational worker is leading the interview and a pain rehabilitation-program
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Aktivní komparátor: Painrehabilitation
Will receive pain-rehabilitation
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a pain rehabilitation-program
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Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
---|---|---|
Absence from work (sickleave) measured with a question to the participants
Časové okno: Changes from baseline in absence from work to the end of the rehab program (average 4month)
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Less absence from work
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Changes from baseline in absence from work to the end of the rehab program (average 4month)
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Absence from work (sickleave) measured with a question to the participants
Časové okno: Changes from baseline in absence from work through study completion (average 1,5 years)
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Less absence from work
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Changes from baseline in absence from work through study completion (average 1,5 years)
|
Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
---|---|---|
Changes in EuroQol 5-dimensions questionnaire (EQ-5D)
Časové okno: Change from baseline in EuroQol 5-dimensions through study completion (average 1,5 years)
|
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)
|
Changes in EuroQol 5-dimensions
Časové okno: Change from baseline in EuroQol 5-dimensions to the end of the rehab program (average foru month)
|
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)
|
Changes in Anxiety and depression
Časové okno: Change from baseline in anxiety and depression through study completion (average 1,5 years)hs)
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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)
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Changes in Anxiety and depression
Časové okno: Change from baseline in anxiety and depression to the end of the rehab program (average four month)
|
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)
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Changes in sleep
Časové okno: Change from baseline in Insomnia Severity Index to the end of the rehab program (average four month)
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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.
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Change from baseline in Insomnia Severity Index to the end of the rehab program (average four month)
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Changes in sleep
Časové okno: Change from baseline in Insomnia Severity Index through study completion (average 1,5 years)
|
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)
|
Changes in Life satisfaction
Časové okno: Change from baseline in Life Satisfaction Questionnaire to the end of the rehab program (average four month)
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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.
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Change from baseline in Life Satisfaction Questionnaire to the end of the rehab program (average four month)
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Changes in Life satisfaction
Časové okno: Change from baseline in Life Satisfaction Questionnaire through study completion (average 1,5 years)
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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.
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Change from baseline in Life Satisfaction Questionnaire through study completion (average 1,5 years)
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Changes in Work ability
Časové okno: Change from baseline in Work ability to the end of the rehab program (average four month)
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Changes in work ability measured with the 7:th question in Work Ability Index questionnaire
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Change from baseline in Work ability to the end of the rehab program (average four month)
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Changes in Work ability
Časové okno: Change from baseline in Work ability through study completion (average 1,5 years)
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Changes in work ability measured with the 7:th question in Work Ability Index questionnaire
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Change from baseline in Work ability through study completion (average 1,5 years)
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Changes in health-related quality of life
Časové okno: Change from baseline in RAND-36 to the end of the rehab program (average four month)
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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).
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Change from baseline in RAND-36 to the end of the rehab program (average four month)
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Changes in health-related quality of life
Časové okno: Change from baseline in RAND-36 through study completion (average 1,5 years)
|
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).
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Change from baseline in RAND-36 through study completion (average 1,5 years)
|
Spolupracovníci a vyšetřovatelé
Sponzor
Vyšetřovatelé
- Vrchní vyšetřovatel: Therese Hellman, PhD, Uppsala University
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Aktuální)
Primární dokončení (Očekávaný)
Dokončení studie (Očekávaný)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Další relevantní podmínky MeSH
Další identifikační čísla studie
- 2019/01755
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