NCT01589536

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

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
480

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2011

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

March 2, 2012

Completed
2 months until next milestone

First Posted

Study publicly available on registry

May 2, 2012

Completed
3.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed
Last Updated

May 2, 2012

Status Verified

April 1, 2012

Enrollment Period

4.2 years

First QC Date

March 2, 2012

Last Update Submit

May 1, 2012

Conditions

Keywords

psychocardiologicalinterval interventiondisability pensionrisk profilemental comorbidity

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

EXPERIMENTAL

A Stationary psychocardiological interval-rehabilitation.

Other: interval-rehabilitation

controlgroup

NO INTERVENTION

The 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.

Also known as: psychocardiological, interval rehabilitation, Roderbirken, comorbidity, sarah
Interventiongroup

Eligibility Criteria

Age18 Years - 58 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

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

RECRUITING

MeSH Terms

Interventions

Comorbidity

Intervention Hierarchy (Ancestors)

Epidemiologic FactorsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Study Officials

  • Wolfgang Mayer-Berger, MD

    Clinic Roderbirken

    PRINCIPAL INVESTIGATOR

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

Locations