Comment Period Extended to 3/23/2015 for Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials
Text Size

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

This study is currently recruiting participants. (see Contacts and Locations)
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Coronary Disease
Myocardial Ischemia
Arterial Occlusive Diseases
 Arteriosclerosis
Cardiovascular Diseases
Heart Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on March 03, 2015