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Requirements and Functional Schedule as a Part of Painrehabilitation.

29. Oktober 2021 aktualisiert von: 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.

Studienübersicht

Detaillierte Beschreibung

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

Studientyp

Interventionell

Einschreibung (Voraussichtlich)

150

Phase

  • Unzutreffend

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienkontakt

Studieren Sie die Kontaktsicherung

Studienorte

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

18 Jahre bis 65 Jahre (Erwachsene, Älterer Erwachsener)

Akzeptiert gesunde Freiwillige

Nein

Studienberechtigte Geschlechter

Alle

Beschreibung

Inclusion Criteria:

Chronic pain, has an employment

Exclusion Criteria:

no longer than 6 month of total sick-leave

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Behandlung
  • Zuteilung: Nicht randomisiert
  • Interventionsmodell: Einzelgruppenzuweisung
  • Maskierung: Keine (Offenes Etikett)

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Experimental: 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
Aktiver Komparator: Painrehabilitation
Will receive pain-rehabilitation
a pain rehabilitation-program

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Absence from work (sickleave) measured with a question to the participants
Zeitfenster: 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
Zeitfenster: 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)

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Changes in EuroQol 5-dimensions questionnaire (EQ-5D)
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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)

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Ermittler

  • Hauptermittler: Therese Hellman, PhD, Uppsala University

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Tatsächlich)

20. Juni 2019

Primärer Abschluss (Voraussichtlich)

20. Dezember 2022

Studienabschluss (Voraussichtlich)

20. Dezember 2023

Studienanmeldedaten

Zuerst eingereicht

16. Juli 2019

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

1. Oktober 2021

Zuerst gepostet (Tatsächlich)

15. Oktober 2021

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

8. November 2021

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

29. Oktober 2021

Zuletzt verifiziert

1. Oktober 2021

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • 2019/01755

Plan für individuelle Teilnehmerdaten (IPD)

Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?

NEIN

Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Nein

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Nein

Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .

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