Trial document



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  DRKS00011418

Trial Description

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Title

OutCaRe - clinical evaluation of potential outcome indicators in cardiac rehabilitation

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Trial Acronym

OutCaRe

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URL of the Trial

http://www.uni-potsdam.de/rehawiss/forschung/projekte/outcare-outcome-der-kardiologischen-rehabilitation-eine-methodenevaluierung-bei-berufsfaehigen-patienten-zur-quantifizierung-des-rehabilitationserfolges.html

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Brief Summary in Lay Language

Cardiac rehabilitation is a multimodal, interdisciplinary intensive measure for patients with chronic cardiovascular disease or after an acute cardiac event such as a myocardial infarction. Medical care, physical training, patient training, nutrition and lifestyle counseling as well as social-medical and psychological care are the core components of cardiac rehabilitation. Thereby functional factors such as physical performance, personal factors such as the reduction of a depressive mood and social aspects such as the return to work should be affected simultaneously.
Due to the high complexity, taking all the involved therapeutic components into account, the success of a cardiac rehabilitation has not been possibly determined through a procedure. In the current study, various parameters of the categories of physical performance, cardiovascular risk factors, social medicine and psychology are to be examined for changes by rehabilitation and their predictive power for return to work after rehabilitation.

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Brief Summary in Scientific Language

Against the background of the social-law obligation to safeguard and develop the quality of medical rehabilitation (§ 20 SGB IX), methods of outcome measurement become increasingly important. In the quality assurance programs of the paying authorities, the dimensions of process and structural quality are currently being examined. The outcome, on the other hand, appears underrepresented and is essentially operationalized by patient and physician consultations at the end or after the rehabilitation procedure.
The outcome is based on the health condition of a patient resulting from a health care measure. Cardiac rehabilitation, however, is a highly complex, interdisciplinary, patient-specific, holistic and intensive medical-therapeutic measure and it´s success couldn´t be defined in general terms. It therefore seems appropriate to identify indicators that show the success of the various core components of cardiac rehabilitation and reflect in their totality the outcome of cardiac rehabilitation. In the course of this evaluation study, the previous Delphi expert survey questioned the importance of performance measures as part of quality assurance by chief physicians, leading sports/physiotherapists and psychologists of cardiac rehabilitation. At the same time, the participants met a selection of potential outcome indicators. The aim of the study is to identify and evaluate performance measures of cardiac rehabilitation for patients under 65 years of age with regard to their suitability and practicability, and to investigate their predictive power for their return to work and health-related quality of life.

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Do you plan to share individual participant data with other researchers?

[---]*

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Description IPD sharing plan:

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Organizational Data

  •   DRKS00011418
  •   2017/03/16
  •   [---]*
  •   yes
  •   Approved
  •   S 4(a)/2017, Ethik-Kommission der Landesärztekammer Brandenburg
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Secondary IDs

  • [---]*
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Health Condition or Problem studied

  •   all indication through a cardiac rehabilitation (ICD 10, chapter IX)
  •   I00-I99 -  Diseases of the circulatory system
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Interventions/Observational Groups

  •   Observational group: Patients in cardiac rehabilitation are studed at the beginning and end of rehabilitation as well as 6 months thereafter on the basis of functional, physical, social-medical and subjective parameters regarding rehabilitation success. This is done using questionnaires as well as clinical documentation.
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Characteristics

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

state of return to work 6 months after rehabilitation (through questionnaire).

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Secondary Outcome

Health-related quality of life 6 months after rehabilitation (through questionnaire).

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • Medical Center 
  • Medical Center 
  • Medical Center 
  • Medical Center 
  • Medical Center 
  • other 
  • Medical Center 
  • Medical Center 
  • Medical Center 
  • Medical Center 
  • Medical Center 
  • Medical Center 
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Recruitment

  •   Actual
  •   2017/05/24
  •   2000
  •   Multicenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   65   Years
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Additional Inclusion Criteria

cardiac rehabilitation payed by any of the German statutory pension insurancy

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Exclusion Criteria

Inadequate knowledge of German and not given consent, early permanent retirement

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Addresses

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    • Universität Potsdam, Professur für Rehabilitationswissenschaften
    • Am Neuen Palais 10
    • 14469  Potsdam
    • Germany
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    •   [---]*
    •   [---]*
    •   [---]*
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    • Deutsche Gesellschaft für Prävention und Rehabilitation von Herz-Kreislauferkrankungen e.V.
    • Friedrich-Ebert-Ring 38
    • 56068  Koblenz
    • Germany
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    •   0261 309231
    •   0261 309232
    •   [---]*
    •   [---]*
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    • Universität Potsdam, Professur für Rehabilitationswissenschaften
    • Ms.  Dr. rer. medic.  Annett  Salzwedel 
    • Am Neuen Palais 10
    • 14469  Potsdam
    • Germany
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    • Universität Potsdam, Professur für Rehabilitationswissenschaften
    • Ms.  Dr. rer. medic.  Annett  Salzwedel 
    • Am Neuen Palais 10
    • 14469  Potsdam
    • Germany
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Sources of Monetary or Material Support

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    • Deutsche Rentenversicherung Bund
    • 10704  Berlin
    • Germany
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    •   [---]*
    •   [---]*
    •   [---]*
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    • Universität Potsdam, Professur für Rehabilitationswissenschaften
    • Am Neuen Palais 10
    • 14469  Potsdam
    • Germany
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    •   [---]*
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Status

  •   Recruiting complete, follow-up complete
  •   2019/01/31
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Trial Publications, Results and other Documents

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