Social Medical Progression of Coronary Heart Disease With Associated Psychosocial Comorbidity -Interval Rehabilitation.
SINKO
Improvement of the Social Medical Progression of Coronary Heart Disease With Associated Psychosocial Comorbidity by the Use of Interval Rehabilitation.
1 other identifier
interventional
480
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Oct 2011
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2011
CompletedFirst Submitted
Initial submission to the registry
March 2, 2012
CompletedFirst Posted
Study publicly available on registry
May 2, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2016
CompletedMay 2, 2012
April 1, 2012
4.2 years
March 2, 2012
May 1, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Secondary Outcomes (1)
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
Study Arms (2)
Interventiongroup
EXPERIMENTALA Stationary psychocardiological interval-rehabilitation.
controlgroup
NO INTERVENTIONThe Patients in the control group receive a personal recommendation concerning psychotherapy outpatient counseling and therapy services at home and take therapeutic help.
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Acute cardiac decompensation
- consuming the underlying disease
- psychotic disorder
- Acute suicidality
- pregnancy
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Clinic Roderbirken
Leichlingen, North Rhine-Westphalia, 42799, Germany
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Wolfgang Mayer-Berger, MD
Clinic Roderbirken
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 2, 2012
First Posted
May 2, 2012
Study Start
October 1, 2011
Primary Completion
December 1, 2015
Study Completion
December 1, 2016
Last Updated
May 2, 2012
Record last verified: 2012-04