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

May 1, 2012 updated by: Clinic Roderbirken

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

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 Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

480

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 58 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
24 months after including study

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
24 months after including study

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Clinic Roderbirken

Investigators

  • Principal Investigator: Wolfgang Mayer-Berger, MD, Clinic Roderbirken

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2011

Primary Completion (Anticipated)

December 1, 2015

Study Completion (Anticipated)

December 1, 2016

Study Registration Dates

First Submitted

March 2, 2012

First Submitted That Met QC Criteria

May 1, 2012

First Posted (Estimate)

May 2, 2012

Study Record Updates

Last Update Posted (Estimate)

May 2, 2012

Last Update Submitted That Met QC Criteria

May 1, 2012

Last Verified

April 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 10001 (Disarm Therapeutics)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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