OutCaRe - clinical evaluation of potential outcome indicators in cardiac rehabilitation

Organizational Data

DRKS-ID:
DRKS00011418
Recruitment Status:
Recruiting complete, study complete
Date of registration in DRKS:
2017-03-16
Last update in DRKS:
2023-06-07
Registration type:
Prospective

Acronym/abbreviation of the study

OutCaRe

URL of the study

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

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.

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.

Health condition or problem studied

Free text:
all indication through a cardiac rehabilitation (ICD 10, chapter IX)
ICD10:
I00-I99 - Diseases of the circulatory system
Healthy volunteers:
No Entry

Interventions, Observational Groups

Arm 1:
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.

Endpoints

Primary outcome:
state of return to work 6 months after rehabilitation (through questionnaire).
Secondary outcome:
Health-related quality of life 6 months after rehabilitation (through questionnaire).

Study Design

Purpose:
Health care system
Retrospective/prospective:
No Entry
Study type:
Non-interventional
Longitudinal/cross-sectional:
No Entry
Study type non-interventional:
No Entry

Recruitment

Recruitment Status:
Recruiting complete, study complete
Reason if recruiting stopped or withdrawn:
No Entry

Recruitment Locations

Recruitment countries:
  • Germany
Number of study centers:
Multicenter study
Recruitment location(s):
  • Medical center Klinik Höhenried der DRV Bayern Süd Bernried
  • Medical center Klinik Höhenried der DRV Bayern Süd Bernried
  • Medical center Frankenklinik Bad Neustadt/Saale
  • Medical center Klinik am See - Rehabilitationszentrum für Innere Medizin Rüdersdorf b. Berlin
  • Medical center MediClin Reha-Zentrum Spreewald Burg
  • Medical center Frankenklinik Bad Neustadt/Saale
  • Medical center SEGEBERGER KLINIKEN GMBH Herzzentrum Bad Segeberg
  • Other Zentrum für ambulante Rehabilitation Stuttgart
  • Medical center Reha-Zentrum Seehof Teltow
  • Medical center Klinik Möhnesee Möhnesee
  • Medical center MediClin-Fachklinik Rhein/Ruhr Essen
  • Medical center Paracelsus-Harz-Klinik Bad Suderode Quedlinburg
  • Medical center Paracelsus-Harz-Klinik Bad Suderode Quedlinburg
  • Medical center Caspar Heinrich Klinik Bad Driburg
  • Medical center Brandenburg Klinik Bernau b. Berlin

Recruitment period and number of participants

Planned study start date:
2017-05-01
Actual study start date:
2017-05-24
Planned study completion date:
No Entry
Actual Study Completion Date:
2019-01-31
Target Sample Size:
2000
Final Sample Size:
1595

Inclusion Criteria

Sex:
All
Minimum Age:
18 Years
Maximum Age:
65 Years
Additional Inclusion Criteria:
cardiac rehabilitation payed by any of the German statutory pension insurancy

Exclusion Criteria

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

Addresses

Primary Sponsor

Address:
Universität Potsdam, Professur für Rehabilitationswissenschaften
Am Neuen Palais 10
14469 Potsdam
Germany
Telephone:
No Entry
Fax:
No Entry
Contact per E-Mail:
Contact per E-Mail
URL:
No Entry
Investigator Sponsored/Initiated Trial (IST/IIT):
Yes

Contact for Scientific Queries

Address:
Universität Potsdam, Professur für Rehabilitationswissenschaften
Dr. rer. medic. Annett Salzwedel
Am Neuen Palais 10
14469 Potsdam
Germany
Telephone:
0331 9774061
Fax:
0331 9774081
Contact per E-Mail:
Contact per E-Mail
URL:
http://uni-potsdam.de/rehawiss

Contact for Public Queries

Address:
Universität Potsdam, Professur für Rehabilitationswissenschaften
Dr. rer. medic. Annett Salzwedel
Am Neuen Palais 10
14469 Potsdam
Germany
Telephone:
0331 9774061
Fax:
0331 9774081
Contact per E-Mail:
Contact per E-Mail
URL:
http://uni-potsdam.de/rehawiss

Principal Investigator

Address:
Universität Potsdam
PD Dr. Annett Salzwedel
Am Mühlenberg 9
14476 Potsdam
Germany
Telephone:
+493319774061
Fax:
No Entry
Contact per E-Mail:
Contact per E-Mail
URL:
No Entry

Sources of Monetary or Material Support

Public funding institutions financed by tax money/Government funding body (German Research Foundation (DFG), Federal Ministry of Education and Research (BMBF), etc.)

Address:
Deutsche Rentenversicherung Bund
10704 Berlin
Germany
Telephone:
No Entry
Fax:
No Entry
Contact per E-Mail:
Contact per E-Mail
URL:
No Entry

Institutional budget, no external funding (budget of sponsor/PI)

Address:
Universität Potsdam, Professur für Rehabilitationswissenschaften
Am Neuen Palais 10
14469 Potsdam
Germany
Telephone:
No Entry
Fax:
No Entry
Contact per E-Mail:
Contact per E-Mail
URL:
No Entry

Ethics Committee

Address Ethics Committee

Address:
Landesärztekammer Brandenburg Ethikkommission
Dreifertstr. 12
03044 Cottbus
Germany
Telephone:
+49-355-7801053
Fax:
+49-355-78011103
Contact per E-Mail:
Contact per E-Mail
URL:
No Entry

Vote of leading Ethics Committee

Vote of leading Ethics Committee
Date of ethics committee application:
2017-02-13
Ethics committee number:
S 4(a)/2017
Vote of the Ethics Committee:
Approved
Date of the vote:
2017-02-23

Further identification numbers

Other primary registry ID:
No Entry
EudraCT Number:
No Entry
UTN (Universal Trial Number):
No Entry
EUDAMED Number:
No Entry

IPD - Individual Participant Data

Do you plan to make participant-related data (IPD) available to other researchers in an anonymized form?:
Yes
IPD Sharing Plan:
Data are available: Salzwedel, Annett, Balzer, Klaus, Koran, Iryna, Langheim, Eike, Schlitt, Axel, Nothroff, Axel, … Völler, Heinz. (2020). Patient-reported outcomes predict return to work and health-related quality of life 6 months after cardiac rehabilitation: Results from a German multi-centre registry (OutCaRe): dataset [Data set]. Zenodo. http://doi.org/10.5281/zenodo.3605618.

Study protocol and other study documents

Study protocols:
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Study abstract:
No Entry
Other study documents:
No Entry
Background literature:
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Related DRKS studies:
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Publication of study results

Basic reporting

Basic Reporting / Results tables:
No Entry
Brief summary of results:
No Entry