Text Size

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

This study is currently recruiting participants.
Verified April 2012 by Clinic Roderbirken
Sponsor:
Information provided by (Responsible Party):
Clinic Roderbirken
ClinicalTrials.gov Identifier:
NCT01589536
First received: March 2, 2012
Last updated: May 1, 2012
Last verified: April 2012
History of Changes
  Purpose

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 Intervention
Cardiovascular Events
 Other: interval-rehabilitation

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: 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.

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Clinic Roderbirken:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    Reducing the rate of disability pension of 18%of 9% by interval-rehabilitation with aftercare.


Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    Reduction of cardiovascular events, including deaths Improving the risk profile Improvement of health-related quality of life Improvement of mental comorbidity


Estimated Enrollment: 480
Study Start Date: October 2011
Estimated Study Completion Date: December 2016
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.

  Eligibility

Ages Eligible for Study:   18 Years to 58 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Clinic Roderbirken
ClinicalTrials.gov Identifier: NCT01589536     History of Changes
Other Study ID Numbers: 10001
Study First Received: March 2, 2012
Last Updated: May 1, 2012
Health Authority: Germany: Ethics Commission

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

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

ClinicalTrials.gov processed this record on May 23, 2013