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Social Medical Progression of Coronary Heart Disease With Associated Psychosocial Comorbidity -Interval Rehabilitation. (SINKO)

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ClinicalTrials.gov Identifier: NCT01589536
Recruitment Status : Unknown
Verified April 2012 by Clinic Roderbirken.
Recruitment status was:  Recruiting
First Posted : May 2, 2012
Last Update Posted : May 2, 2012
Sponsor:
Information provided by (Responsible Party):
Clinic Roderbirken

Study Description
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Brief Summary:
The purpose of the study is to verfiy the hypothesis if a short intensive psychocardiological interval-intervention, combined with a structured follow up, decreases the rate of disability retirements caused by psychosocial co-morbidity of patients with coronary heart disease.

Condition or disease Intervention/treatment Phase
Cardiovascular Events Other: interval-rehabilitation Not Applicable

Detailed Description:
The purpose of the study is to verfiy the hypothesis if a short intensive psychocardiological interval intervention, combined with a structured follow up, decreases the rate of disability retirements caused by psychosocial co-morbidity of patients with coronary heart disease.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 480 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Improvement of the Social Medical Progression of Coronary Heart Disease With Associated Psychosocial Comorbidity by the Use of Interval Rehabilitation.
Study Start Date : October 2011
Estimated Primary Completion Date : December 2015
Estimated Study Completion Date : December 2016

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Arms and Interventions
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Arm Intervention/treatment
Experimental: Interventiongroup
A Stationary psychocardiological interval-rehabilitation.
 Other: interval-rehabilitation
The Patients in the intervention group receive a Stationary psychocardiological interval-rehabilitation.The Interval rehabilitation is divided into individual psychological therapy with focus of Behavior therapy and relaxation therapy.
Other Names:
  • psychocardiological
  • interval rehabilitation
  • Roderbirken
  • comorbidity
  • sarah
No Intervention: controlgroup
The Patients in the control group receive a personal recommendation concerning psychotherapy outpatient counseling and therapy services at home and take therapeutic help.


Outcome Measures
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Primary Outcome Measures :
  1. Improvement of the social medical progression of coronary heart disease with associated psychosocial comorbidity by the use of interval rehabilitaion [ Time Frame: 24 months after including study ]
    Reducing the rate of disability pension of 18%of 9% by interval-rehabilitation with aftercare.


Secondary Outcome Measures :
  1. Improvement of the social medical progression of coronary heart disease with associated psychosocial comorbidity by the use of interval rehabilitaion [ Time Frame: 24 months after including study ]
    Reduction of cardiovascular events, including deaths Improving the risk profile Improvement of health-related quality of life Improvement of mental comorbidity


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 58 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Coronary heart disease
  • Disease-related psychosocial morbidity
  • not a disability retirements
  • Insured with the German Rheinland pension (deutsche Rentenversicherung Rheinland)
  • Sufficient language skills
  • Age 18-58

Exclusion Criteria:

  • Acute cardiac decompensation
  • consuming the underlying disease
  • psychotic disorder
  • Acute suicidality
  • pregnancy
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01589536


Locations
Germany
Clinic Roderbirken Recruiting
Leichlingen, NRW, Germany, 42799
Contact: Sarah Neuhaeuser    :+ 49 (2175) 82 - 3352    sarah.neuhaeuser@klinik-roderbirken.de   
Contact: Wolfgang Mayer-Berger, Dr. med.    +49 (2175) 82-4010    wolfgang.mayer-berger@klinik-roderbirken.de   
Principal Investigator: Wolfgang Mayer-Berger, Dr.med.         
Sponsors and Collaborators
Clinic Roderbirken
Investigators
Principal Investigator: Wolfgang Mayer-Berger, MD Clinic Roderbirken
More Information
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Responsible Party: Clinic Roderbirken
ClinicalTrials.gov Identifier: NCT01589536     History of Changes
Other Study ID Numbers: 10001
First Posted: May 2, 2012    Key Record Dates
Last Update Posted: May 2, 2012
Last Verified: April 2012

Keywords provided by Clinic Roderbirken:
psychocardiological
interval intervention
disability pension
risk profile
mental comorbidity

Additional relevant MeSH terms:
Heart Diseases
Coronary Disease
Coronary Artery Disease
Myocardial Ischemia
 Cardiovascular Diseases
Vascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases