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Requirements and Functional Schedule as a Part of Painrehabilitation.

29. října 2021 aktualizováno: Katarina Danielsson, Uppsala University

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.

Přehled studie

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

Intervenční

Zápis (Očekávaný)

150

Fáze

  • Nelze použít

Kontakty a umístění

Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.

Studijní kontakt

Studijní záloha kontaktů

Studijní místa

Kritéria účasti

Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.

Kritéria způsobilosti

Věk způsobilý ke studiu

18 let až 65 let (Dospělý, Starší dospělý)

Přijímá zdravé dobrovolníky

Ne

Pohlaví způsobilá ke studiu

Všechno

Popis

Inclusion Criteria:

Chronic pain, has an employment

Exclusion Criteria:

no longer than 6 month of total sick-leave

Studijní plán

Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.

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)
An interview with the employee and the employer where the occupational worker is leading the interview and a pain rehabilitation-program
Aktivní komparátor: Painrehabilitation
Will receive pain-rehabilitation
a pain rehabilitation-program

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)
Less absence from work
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
Časové okno: Changes from baseline in absence from work through study completion (average 1,5 years)
Less absence from work
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)
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)
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)
Changes in sleep
Časové okno: Change from baseline in Insomnia Severity Index to the end of the rehab program (average four month)
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)
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)
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)
Changes in Life satisfaction
Časové okno: Change from baseline in Life Satisfaction Questionnaire through study completion (average 1,5 years)
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)
Changes in Work ability
Časové okno: Change from baseline in Work ability to the end of the rehab program (average four month)
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)
Changes in Work ability
Časové okno: Change from baseline in Work ability through study completion (average 1,5 years)
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)
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)
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)
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).
Change from baseline in RAND-36 through study completion (average 1,5 years)

Spolupracovníci a vyšetřovatelé

Zde najdete lidi a organizace zapojené do této studie.

Vyšetřovatelé

  • Vrchní vyšetřovatel: Therese Hellman, PhD, Uppsala University

Termíny studijních záznamů

Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.

Hlavní termíny studia

Začátek studia (Aktuální)

20. června 2019

Primární dokončení (Očekávaný)

20. prosince 2022

Dokončení studie (Očekávaný)

20. prosince 2023

Termíny zápisu do studia

První předloženo

16. července 2019

První předloženo, které splnilo kritéria kontroly kvality

1. října 2021

První zveřejněno (Aktuální)

15. října 2021

Aktualizace studijních záznamů

Poslední zveřejněná aktualizace (Aktuální)

8. listopadu 2021

Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality

29. října 2021

Naposledy ověřeno

1. října 2021

Více informací

Termíny související s touto studií

Další relevantní podmínky MeSH

Další identifikační čísla studie

  • 2019/01755

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NE

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Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .

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