Trial document




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  DRKS00000655

Trial Description

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Title

Development and evaluation of a patient education intervention to improve health literacy (HL) for patients with chronic illness

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Trial Acronym

GeKo

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URL of the Trial

[---]*

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Brief Summary in Lay Language

The current project focuses on health literacy (HL) of patients with chronic illness. In the project, a basic patient education intervention is to be developed that accounts for the special needs of rehabilitation patients with low HL. It is to be conducted in advance of or parallel to established health education interventions and will make it easier for participants to benefit from these interventions. One aim of the project consists of the development and evaluation of this HL patient education. Another objective of the project consists of the development and psychometric testing of a patient questionnaire that measures the perceived fit of education requirements to the own HL (HALEDU questionnaire).
The HL patient education will be implemented in nine rehabilitation centers and is directed at patients with chronic back pain or arthritis.

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Brief Summary in Scientific Language

1. Project objective:
In the project, a basic patient education intervention is to be developed that is coordinated with the special needs of rehabilitation patients with low health literacy (HL), which is to be conducted in advance of or parallel to established health education interventions and will make it easier for participants to benefit from this interventions. The primary objective of the project consists of the development and evaluation of this HL patient education. The secondary objective of the project consists of the development and psychometric testing of a patient questionnaire that measures the perceived fit of education requirements to the own HL (HALEDU questionnaire).

2. Planning:
To develop the HL patient education, focus groups with patients and trainers and a meeting of experts will be conducted. The HL patient education will be implemented in six rehabilitation centers and is directed at patients with chronic back pain or arthrosis. The evaluation will be made in a controlled design with a historical control group. Primary criteria are the fit of the intervention to the HL of the patients and the overall assessment of the program, while secondary criteria are the success of the intervention with respect to health behavior, self-regulation, adherence, etc. Cognitive interviews and a pretest will be conducted for developing the HALEDU questionnaire.

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Organizational Data

  •   DRKS00000655
  •   2011/01/21
  •   [---]*
  •   yes
  •   Approved
  •   369/10, Ethik-Kommission der Albert-Ludwigs-Universität Freiburg
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Secondary IDs

  •   U1111-1119-0464 
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Health Condition or Problem studied

  •   M15-M19 -  Arthrosis
  •   chronic back pain (ICD-10: M47.1-M47.9, M48.1, M48.2, M48.8; M48.9, M51.0-M51.9, M53.8, M53.9, M54.1, M54.3, M54.4, M54.5, M54.8, M54.9, F45.4)
  •   M47.1 -  Other spondylosis with myelopathy
  •   M47.2 -  Other spondylosis with radiculopathy
  •   M47.8 -  Other spondylosis
  •   M47.9 -  Spondylosis, unspecified
  •   M48.1 -  Ankylosing hyperostosis [Forestier]
  •   M48.2 -  Kissing spine
  •   M48.8 -  Other specified spondylopathies
  •   M48.9 -  Spondylopathy, unspecified
  •   M51.0 -  Lumbar and other intervertebral disc disorders with myelopathy
  •   M51.1 -  Lumbar and other intervertebral disc disorders with radiculopathy
  •   M51.2 -  Other specified intervertebral disc displacement
  •   M51.3 -  Other specified intervertebral disc degeneration
  •   M51.4 -  Schmorl's nodes
  •   M51.8 -  Other specified intervertebral disc disorders
  •   M51.9 -  Intervertebral disc disorder, unspecified
  •   M53.8 -  Other specified dorsopathies
  •   M53.9 -  Dorsopathy, unspecified
  •   M54.1 -  Radiculopathy
  •   M54.3 -  Sciatica
  •   M54.4 -  Lumbago with sciatica
  •   M54.5 -  Low back pain
  •   M54.8 -  Other dorsalgia
  •   M54.9 -  Dorsalgia, unspecified
  •   F45.4 -  Persistent somatoform pain disorder
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Interventions/Observational Groups

  •   Intervention group: health education intervention to improve health literacy for patients with chronic illness (low back pain, arthritis) added to clinics' standard health education program
  •   Historical control group: no supplementary health education intervention to improve health literacy
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Characteristics

  •   Interventional
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  •   Non-randomized controlled trial
  •   Open (masking not used)
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  •   Historical
  •   Treatment
  •   Other
  •   N/A
  •   [---]*
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Primary Outcome

Development of a health education intervention to improve health literacy in patients with chronic back pain and arthritis. Qualitative pilot study: group based interviews with patients and health education trainers.
Quantitative pilot study: assessing the psychometric property of a newly self-developed questionnaire assessing the fit between health literacy and health education (HALEDU).
Evaluation of the newly developed health education intervention to improve health literacy (quantitative main study, measurement occasions: before rehab, after rehab, 3 month after rehab):
Fit between the health education programme run through by the patient during inpatient rehabilitation to his own health literacy using the HALEDU questionnaire.
Overall estimation of the developed health education intervention (utiliy, relevance, etc.) using the “programme-evaluation” scale of the “Health Education Impact Questionnaire” (heiQ).

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Secondary Outcome

Evaluation of the health intervention programme regarding rehabilitation outcome in general (measurement occasions: before rehab, after rehab, 3 month after rehab):
Health related behaviour, self-regulation, adherence to behavioural recommendations, self-management competencies, disease management (Health Eudcation Impact Questionnaire (heiQ), Questionnaire Assessing Health Related Behaviour [in German], Questionnaire Assessing Illness- and Health Related Control Convictions [in German], Freiburg Questionnaire of Disease Management [in German].
Evaluation of the health education intervention by health education trainers (acceptance/ perceived utility) using a self-developed questionnaire

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • [---]*
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Recruitment

  •   Actual
  •   2012/04/01
  •   500
  •   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

Diagnosis (chronic back pain, arthritis)

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Exclusion Criteria

language impairment; cognitive and/or physical impairment (patient is not able to fill out questionnaire)

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Addresses

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    • Universitätaklinikum Freiburg Institut für Qualitätsmanagement und Sozialmedizin
    • Engelbergerstr. 21
    • 79106  Freiburg
    • Germany
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    •   0761-27074470
    •   0761-27073310
    •   [---]*
    •   http://www.aqms.de
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    • Universitätsklinikum Freiburg Institut für Qualitätsmanagement und Sozialmedizin
    • Mr.  Prof. Dr.  Erik  Farin-Glattacker 
    • Engelbergerstr. 21
    • 79106  Freiburg
    • Germany
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    • Universitätsklinikum Freiburg Institut für Qualitätsmanagement und Sozialmedizin
    • Ms.  Dipl.Psych.  Antje  Ullrich 
    • Engelbergerstr. 21
    • 79106  Freiburg
    • Germany
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Sources of Monetary or Material Support

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    • Deutsches Zentrum für Luft- und Raumfahrt e.V. (DLR), Projektträger des BMBF, Gesundheitsforschung
    • Ms.  Dr.  Annika  Putz 
    • Heinrich-Konen-Straße 1
    • 53227  Bonn
    • Germany
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Status

  •   Recruiting complete, follow-up complete
  •   2014/05/31
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Trial Publications, Results and other Documents

  •   Nagl M, Ullrich A, Farin E. Verständlichkeit von Patientenschulungen in der orthopädischen Rehabilitation: Qualitative Erhebung bei Rehabilitanden und Schulungsleitern. Die Rehabilitation 2013, 52:34–39.
  •   Farin, E, Nagl, M, Ullrich, A. The comprehensibility of health education programs: Questionnaire development and results in patients with chronic musculoskeletal diseases. Patient Education and Counseling 2013, 90(2):239–246.
  •   Farin, E, Nagl, M, Ullrich, A. Health education literacy in patients with chronic musculoskeletal diseases: Development of new questionnaire and sociodemographical predictors. Health Educ Res 2013, 28(6):1080-1091.
  •   Ullrich A, Schöpf AC, Nagl M, Farin E. „Aktiv in der Reha“: Entwicklung und formative Evaluation einer Patientenschulung zur Förderung der Gesundheitskompetenz von chronisch Kranken. Die Rehabilitation.2015, 54: 109-115.
  •   Schöpf AC, Ullrich A, Nagl M, Farin E (im Druck). Group health education in inpatient rehabilitation: Patients’ role perceptions. Health Education Journal.
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* This entry means the parameter is not applicable or has not been set.