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Social Medical Progression of Coronary Heart Disease With Associated Psychosocial Comorbidity -Interval Rehabilitation. (SINKO)
The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified April 2012 by Clinic Roderbirken.
Recruitment status was: Recruiting
Recruitment status was: Recruiting
Sponsor:
Clinic Roderbirken
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
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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: 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. |
Resource links provided by NLM:
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 ]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 ]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:
|
|
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 (Adult) |
| Sexes Eligible for Study: | All |
| 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
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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
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
| 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 |
Keywords provided by Clinic Roderbirken:
|
psychocardiological interval intervention disability pension risk profile mental comorbidity |
Additional relevant MeSH terms:
|
Heart Diseases Coronary Disease Coronary Artery Disease Myocardial Ischemia |
Cardiovascular Diseases Vascular Diseases Arteriosclerosis Arterial Occlusive Diseases |
ClinicalTrials.gov processed this record on September 21, 2017