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

Cardiovascular Events Clinical Trial

— SINKO  

Official title:

Improvement of the Social Medical Progression of Coronary Heart Disease With Associated Psychosocial Comorbidity by the Use of Interval Rehabilitation.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01589536
• Other study ID #: 10001
• Status: Recruiting
• Phase: N/A
• First received: March 2, 2012
• Last updated: May 1, 2012
• Start date: October 2011
• Est. completion date: December 2016

Study information

• Verified date: April 2012
• Source: Clinic Roderbirken
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 480
• Est. completion date: December 2016
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 58 Years

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cardiovascular Events
• Coronary Artery Disease
• Coronary Disease
• Heart Diseases
• Myocardial Ischemia

Intervention

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.

Locations

Country	Name	City	State
Germany	Clinic Roderbirken	Leichlingen	NRW

Sponsors (1)

Lead Sponsor	Collaborator
Clinic Roderbirken

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Improvement of the social medical progression of coronary heart disease with associated psychosocial comorbidity by the use of interval rehabilitaion	Reducing the rate of disability pension of 18%of 9% by interval-rehabilitation with aftercare.	24 months after including study	No
Secondary	Improvement of the social medical progression of coronary heart disease with associated psychosocial comorbidity by the use of interval rehabilitaion	Reduction of cardiovascular events, including deaths Improving the risk profile Improvement of health-related quality of life Improvement of mental comorbidity	24 months after including study	No