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
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 RehabilitationswissenschaftenAm Neuen Palais 1014469 PotsdamGermany
- 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 RehabilitationswissenschaftenDr. rer. medic. Annett SalzwedelAm Neuen Palais 1014469 PotsdamGermany
- 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 RehabilitationswissenschaftenDr. rer. medic. Annett SalzwedelAm Neuen Palais 1014469 PotsdamGermany
- Telephone:
- 0331 9774061
- Fax:
- 0331 9774081
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- http://uni-potsdam.de/rehawiss
Principal Investigator
- Address:
- Universität PotsdamPD Dr. Annett SalzwedelAm Mühlenberg 914476 PotsdamGermany
- 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 Bund10704 BerlinGermany
- 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 RehabilitationswissenschaftenAm Neuen Palais 1014469 PotsdamGermany
- 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 EthikkommissionDreifertstr. 1203044 CottbusGermany
- 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
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:
- No Entry
- Study abstract:
- No Entry
- Other study documents:
- No Entry
- Background literature:
- No Entry
- Related DRKS studies:
- No Entry
Publication of study results
- Planned publication:
- No Entry
- Publikationen/Studienergebnisse:
- Ergebnisse der ersten OutCaRe-Projektphase (Delphi-Expertenbefragung), die der klinischen Evaluation vorangegangen ist (https://doi.org/10.1055/s-0044-101048)
- Performance Measures for Short-Term Cardiac Rehabilitation in Patients of Working Age: Results of the Prospective Observational Multicenter Registry OutCaRe
- Patient-reported outcomes predict return to work and health-related quality of life six months after cardiac rehabilitation: Results from a German multi-centre registry (OutCaRe)
- Cardiac Rehabilitation: Patient-Reported Outcomes Are Decisive for Success
- Date of first publication of study results:
- 2018-03-28
- DRKS entry published for the first time with results:
- No Entry
Basic reporting
- Basic Reporting / Results tables:
- No Entry
- Brief summary of results:
- No Entry