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

Sponsor

Clinic Roderbirken (Other)

Overall Status

Unknown status

CT.gov ID

NCT01589536

Collaborator

(none)

480

Enrollment

Location

Arms

Duration (Months)

7.7

Patients Per Site Per Month

Study Details

Study Description

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	N/A

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

Study Type:

Interventional

Anticipated 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 :

Oct 1, 2011

Anticipated Primary Completion Date :

Dec 1, 2015

Anticipated Study Completion Date :

Dec 1, 2016

Arms and Interventions

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.

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

Primary Outcome Measures

Improvement of the social medical progression of coronary heart disease with associated psychosocial comorbidity by the use of interval rehabilitaion [24 months after including study]
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 [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

Criteria

Ages Eligible for Study:

18 Years to 58 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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