Back to resultsSocial Medical Progression of Coronary Heart Disease With Associated Psychosocial Comorbidity -Interval Rehabilitation. (SINKO)
Primary Purpose
Cardiovascular Events
Status
Unknown status
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
interval-rehabilitation
Sponsored by
About this trial
This is an interventional treatment trial for Cardiovascular Events focused on measuring psychocardiological, interval intervention, disability pension, risk profile, mental comorbidity
Eligibility 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
Sites / Locations
- Clinic RoderbirkenRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Interventiongroup
controlgroup
Arm Description
A Stationary psychocardiological interval-rehabilitation.
The Patients in the control group receive a personal recommendation concerning psychotherapy outpatient counseling and therapy services at home and take therapeutic help.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01589536
Brief Title
Social Medical Progression of Coronary Heart Disease With Associated Psychosocial Comorbidity -Interval Rehabilitation.
Acronym
SINKO
Official Title
Improvement of the Social Medical Progression of Coronary Heart Disease With Associated Psychosocial Comorbidity by the Use of Interval Rehabilitation.
Study Type
Interventional
2. Study Status
Record Verification Date
April 2012
Overall Recruitment Status
Unknown status
Study Start Date
October 2011 (undefined)
Primary Completion Date
December 2015 (Anticipated)
Study Completion Date
December 2016 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Clinic Roderbirken
4. Oversight
Data Monitoring Committee
Yes
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cardiovascular Events
Keywords
psychocardiological, interval intervention, disability pension, risk profile, mental comorbidity
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
480 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Interventiongroup
Arm Type
Experimental
Arm Description
A Stationary psychocardiological interval-rehabilitation.
Arm Title
controlgroup
Arm Type
No Intervention
Arm Description
The Patients in the control group receive a personal recommendation concerning psychotherapy outpatient counseling and therapy services at home and take therapeutic help.
Intervention Type
Other
Intervention Name(s)
interval-rehabilitation
Other Intervention Name(s)
psychocardiological, interval rehabilitation, Roderbirken, comorbidity, sarah
Intervention Description
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.
Primary Outcome Measure Information:
Title
Improvement of the social medical progression of coronary heart disease with associated psychosocial comorbidity by the use of interval rehabilitaion
Description
Reducing the rate of disability pension of 18%of 9% by interval-rehabilitation with aftercare.
Time Frame
24 months after including study
Secondary Outcome Measure Information:
Title
Improvement of the social medical progression of coronary heart disease with associated psychosocial comorbidity by the use of interval rehabilitaion
Description
Reduction of cardiovascular events, including deaths Improving the risk profile Improvement of health-related quality of life Improvement of mental comorbidity
Time Frame
24 months after including study
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
58 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Wolfgang Mayer-Berger, MD
Organizational Affiliation
Clinic Roderbirken
Official's Role
Principal Investigator
Facility Information:
Facility Name
Clinic Roderbirken
City
Leichlingen
State/Province
NRW
ZIP/Postal Code
42799
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sarah Neuhaeuser
Phone
:+ 49 (2175) 82 - 3352
Email
sarah.neuhaeuser@klinik-roderbirken.de
First Name & Middle Initial & Last Name & Degree
Wolfgang Mayer-Berger, Dr. med.
Phone
+49 (2175) 82-4010
Email
wolfgang.mayer-berger@klinik-roderbirken.de
First Name & Middle Initial & Last Name & Degree
Wolfgang Mayer-Berger, Dr.med.
12. IPD Sharing Statement
Learn more about this trial
Social Medical Progression of Coronary Heart Disease With Associated Psychosocial Comorbidity -Interval Rehabilitation.
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