Trial document





This trial has been registered retrospectively.
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  DRKS00000744

Trial Description

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Title

Patient-oriented outcome measurement: Health valuations and the assessment of the participation relevance of treatment effects by chronically ill patients (POEM)

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Trial Acronym

POEM

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URL of the Trial

[---]*

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Brief Summary in Lay Language

The project focuses the question how the outcome of health related interventions in rehabilitation of chronically ill can be assessed properly. A questionnaire is to be developed in which Patients are able to state their preferences regarding potential health related outcomes at the beginning of the rehabilitation. For the evaluation of the results achieved by the rehabilitation it is also interesting to assess the treatment's consequences for the patients' daily life at the end of the rehabilitation. Using such a questionnaire in the rehabilitation routine it would be possible to let the patient participate even more as earlier in treatment planning. Patients with the following diagnosis are participating in the project: breast cancer, chronic ischemic heart disease, chronic back pain.

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Brief Summary in Scientific Language

The project focuses on the methodological development and implementation of a “patient-oriented measurement of change” for three diagnoses: breast cancer, chronic ischemic heart disease, and chronic back pain. The concept “patient-oriented measurement of change” consists of the assessment of the patients’ preferences (health valuations) regarding different potential health relates outcomes at the beginning of the rehabilitation. After the rehabilitation the patient is asked to evaluate the consequences of the treatment outcome for his/ her daily life, e.g. participation in work life and social life. The health valuations represent the patients’ preferences whereas the perceived relevance for the patients’ participation in daily life is assessed in order to integrate the patients’ subjective perspective in the evaluation of treatment outcome. The project consits of a pilot phase in wich the instrument is developed on the basis of qualitative interviews as well as a quantitative main study adressing the evaluation of the concept.

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Organizational Data

  •   DRKS00000744
  •   2011/03/18
  •   [---]*
  •   yes
  •   Approved
  •   63/08, Ethik-Kommission der Albert-Ludwig-Universität Freiburg
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Secondary IDs

  •   U1111-1119-6484 
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Health Condition or Problem studied

  •   C50 -  Malignant neoplasm of breast
  •   I25 -  Chronic ischaemic heart disease
  •   M47 -  Spondylosis
  •   M48 -  Other spondylopathies
  •   M48.5 -  Collapsed vertebra, not elsewhere classified
  •   M51 -  Other intervertebral disc disorders
  •   M53 -  Other dorsopathies, not elsewhere classified
  •   M54 -  Dorsalgia
  •   F45.4 -  Persistent somatoform pain disorder
  •   CHRONIC BACK PAIN (M47 M48 M48.5 M51 M54 F45.49)
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Interventions/Observational Groups

  •   Sample of Patients with chronic illness attending inpatient rehabilitation
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Characteristics

  •   Non-interventional
  •   Observational study
  •   Single arm study
  •   Open (masking not used)
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  •   Uncontrolled/Single arm
  •   Other
  •   Single (group)
  •   N/A
  •   [---]*
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Primary Outcome

Development and implementation of the concept "patient-oriented measurement of change".
qualitative pilot studies: group interviews and cognitive interviews to develop the instrument
quantitative main study (3 measurement occasions: before rehab, after rehab, and 6 month after rehab): psychometric evalutation of the instrument and assessment of secondary research questions.
Instruments for the assessment of health related quality of life:
Functional Assessment of Cancer Therapy, FACT-B, Questionnaire assessing the Stresses of Cancer Patients (in German, FBK-R23), Seattle Angina Questionnaire SAQ, MacNew Fragebogen, Oswestry Disability Questionnaire ODI, Questionnaire to Assess Pain Processing (in German; FESV), SF-12

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Secondary Outcome

Assessment of potential influencing facotors regarding the outcome of the rehabilitation (measurement occasion: beginnig of rehab) using the Life Orientation Test (LOT) to assess dispositional optimism, State-Trait-Anger Expression Inventory (STAXI) for the assessment of dispositional anger expression, Cook Medley Hostility Scale to assess hostility, Fear Avoidance Beflief Questionnaire for the assessment of cognitive beliefs that are related with back pain

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • [---]*
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Recruitment

  •   Actual
  •   2008/04/01
  •   600
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   no maximum age
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Additional Inclusion Criteria

Breast cancer, ischemic heart disease, chronic back pain, informed consent to participate in the study, adequate german language abilities, cognitive and physical ablility to fill out questionnaires

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Exclusion Criteria

Patients with herniated vertebral disc, "specific" back pain, back pain caused by tumors or inflammatory diseases

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Addresses

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    • Universitätsklinikum Freiburg Abteilung Qualitätsmanagement und Sozialmedizin
    • Engelbergerstraße 21
    • 79106  Freiburg
    • Germany
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    •   0761/270-74470
    •   0761/270-73310
    •   [---]*
    •   http://www.aqms.de
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    • Universitätsklinikum Freiburg Abteilung Qualitätsmanagement und Sozialmedizin
    • Mr.  PD Dr.  Erik  Farin-Glattacker 
    • Engelbergerstraße 21
    • 79106   Freiburg
    • Germany
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    • Universitätsklinikum Freiburg Abteilung Qualitätsmanagement und Sozialmedizin
    • Ms.  Dipl. Psych.  Michaela  Nagl 
    • Engelbergerstraße 21
    • 79106  Freibrug
    • Germany
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Sources of Monetary or Material Support

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    • Bundesministerium für Bildung und Forschung
    • Ms.  Sandra   Schenke 
    • Hannoversche Straße 28-30
    • 10115  Berlin
    • Germany
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Status

  •   Recruiting complete, follow-up complete
  •   2011/02/28
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Trial Publications, Results and other Documents

  •   Farin, F. & Meder, M. (2010). Personality and the physician-patient relationship as predictors of quality of life of cardiac patients after rehabilitation. Health and Quality of Life Outcomes, 8: 100
  •   Meder, M. & Farin, E. (2009). Akzeptanz und Verständlichkeit verschiedener Methoden der Gesundheitsbewertung bei chronisch Kranken: Willingness to pay, visuelle Analogskala und verbale Ratingskala. Gesundheitswesen, 71(11), e1-e10.
  •   Farin, E. Farin, E. (2008). Patientenorientierung und ICF-Bezug als Herausforderun-gen für die Ergebnismessung in der Rehabilitation. Rehabilitation, 47, 67-76.
  •   Nagl M, Farin E: Patientenorientierte Veränderungsmessung: Die Stabilität der von chronisch Kranken wahrgenommenen Teilhabe-Relevanz einer gesundheitlichen Veränderung. Monitor Versorgungsforschung, 2010: 43 (9. Deutscher Kongress für Versorgungsforschung/Bonn/DNVF 01.10.2010)
  •   Farin E, Meder M: Der Einfluss von Persönlichkeitsvariablen und der Arzt-Patient-Beziehung auf die Lebensqualität kardiologischer Patienten nach einer Rehabilitation. Das Gesundheitswesen, 2010; 8/9: 538 (DGSMP-Kongress/Berlin/DGSMP zs. mit DGEPI 22.09.2010)
  •   Farin E, Meder M: Welche Methode empfiehlt sich zur Erfassung von Gesundheitsbewertungen (health valuations) chronisch Kranker? DRV Schriften, 2010; 88: 222-224 (19. Rehabilitationswissenschaftliches Kolloquium/08.03.2010 in Leipzig/Deutsche Rentenversicherung Bund), Deutsche Rentenversicherung Bund (Hrsg)
  •   Meder M, Farin E: Gesundheitsbewertungen bei Patienten mit chronisch-ischämischer Herzkrankheit: Geschlechtsunterschiede und Einflussfaktoren. DRV Schriften, 2010; 88: 229-230 (19. Rehabilitationswissenschaftliches Kolloquium/08.03.2010 in Leipzig/Deutsche Rentenversicherung Bund), DRV Bund (Hrsg)
  •   Kriesch M, Farin E: Willingness to pay als Methode zur Erfassung von Patientenpräferenzen in der Ergebnisbewertung: Verständlichkeit und Akzeptanz. DRV-Schriften, 2009; 83: 95-97 (18. Rehabilitationswissenschaftliches Kolloquium, vom 10.03.2009 in Münster, Deutsche Rentenversicherung Bund), Deutsche Rentenversicherung Bund (Hrsg)
  •   Farin E, Kriesch M: Patientenorientierte Veränderungsmessung: Akzeptanz und Verständlichkeit verschiedener Methoden zur Erfassung von Gesundheitsbewertungen. German Medical Science GMS Publishing House, 2008; P5.2 (Deutscher Kongress für Versorgungsforschung vom 17.10.08 in Köln, DNVF)
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