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

Study Description

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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 Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

Arms and Interventions

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party:	Clinic Roderbirken
ClinicalTrials.gov Identifier:	NCT01589536 History of Changes
Other Study ID Numbers:	10001
First Posted:	May 2, 2012
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