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Requirements and Functional Schedule as a Part of Painrehabilitation.

29. oktober 2021 oppdatert av: 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.

Studieoversikt

Status

Rekruttering

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

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

Studietype

Intervensjonell

Registrering (Forventet)

150

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

Studer Kontakt Backup

Studiesteder

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

18 år til 65 år (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

Inclusion Criteria:

Chronic pain, has an employment

Exclusion Criteria:

no longer than 6 month of total sick-leave

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Ikke-randomisert
  • Intervensjonsmodell: Enkeltgruppeoppdrag
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: 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)
Atferdsmessig: 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
Aktiv komparator: Painrehabilitation
Will receive pain-rehabilitation
Atferdsmessig: No intervention
a pain rehabilitation-program

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Absence from work (sickleave) measured with a question to the participants
Tidsramme: 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
Tidsramme: 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)

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Changes in EuroQol 5-dimensions questionnaire (EQ-5D)
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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)

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Uppsala University

Etterforskere

  • Hovedetterforsker: Therese Hellman, PhD, Uppsala University

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

20. juni 2019

Primær fullføring (Forventet)

20. desember 2022

Studiet fullført (Forventet)

20. desember 2023

Datoer for studieregistrering

Først innsendt

16. juli 2019

Først innsendt som oppfylte QC-kriteriene

1. oktober 2021

Først lagt ut (Faktiske)

15. oktober 2021

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

8. november 2021

Siste oppdatering sendt inn som oppfylte QC-kriteriene

29. oktober 2021

Sist bekreftet

1. oktober 2021

Mer informasjon

Begreper knyttet til denne studien

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • 2019/01755

Plan for individuelle deltakerdata (IPD)

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