Clinical trial NCT01626027: Depression Care for Hospitalized Coronary Heart Disease Patients: Prospective Cohort Study
Official title: Depression Care for Hospitalized Coronary Heart Disease Patients: Bridging the Gap Between Guidelines and Reality
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Coronary Heart Disease
Depression
Keywords: Coronary Heart Disease
Depression
Health Care Services
Lead sponsor: Charite University, Berlin, Germany
Sponsor class: OTHER
Collaborators: name: University Hospital Muenster
First posted: 2012-06-22
Enrollment: 1265
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with confirmed Coronary Heart Disease (CHD) hospitalized in the coronary care units of 2 University hospitals in Germany. Additionally, starting August 2012, patients with confirmed CHD who receive ambulatory care at one of the cardiology clinics will also be enrolled.

Brief summary: The aims of this prospective, observational study are to assess the current use of depression care in Coronary Heart Disease (CHD) patients, and to provide estimates for the resources needed to implement guideline-oriented depression health care acceptable to CHD patients with comorbid depression.

Detailed description: In patients with established CHD, unipolar depression is up to three times more prevalent than in the general population and increases the risk for coronary events and mortality, higher health care consumption and decreased quality of life. Most hospitals in Germany have a unique infrastructure of psychiatric, psychosomatic and psychosocial services for CHD patients (psychiatric/psychosomatic consultation liaison services and a wide network of inpatient or outpatient cardiac rehabilitation centers). However, as of today, little is known about the current use and acceptability of depression health care from the perspective of CHD patients.

This project has two main aims:

1. to assess the current use of depression care in CHD patients who are hospitalized or receive ambulatory care at a cardiology clinic
2. to provide estimates for the resources needed to implement guideline-oriented depression health care acceptable to CHD patients with comorbid depression.

Specifically, the investigators will assess

* rates of and satisfaction with depression health care use in hospitalized CHD patients within one year after hospitalization
* perceived need for depression care and patient preferences for different types, settings and providers of these services
* correlates of depression health care use and patient preferences
* the amount of patients in need for depression health care according to existing recommendations

The secondary objective is to assess direct and indirect costs associated with depressive symptoms and depression care use across 1 year (as indicated by quality of life, event-free survival, productivity, and health care costs).

Eligibility criteria: Inclusion Criteria:

* chronic CHD (confirmed by a clinician)

Exclusion Criteria:

* chart-documented dementia disorder
* cognitive impairment
* life expectancy \< 1 year
* unavailability for follow-up
* insufficient proficiency in German or Turkish language

Primary outcomes:
measure: Percentage of participants in depression care during the 12 months after hospitalization
timeFrame: Baseline and within one year after hospitalization
Secondary outcomes:
measure: Percentage of participants reporting current utilization of mental health care and satisfaction with mental health care
timeFrame: Baseline and within one year after hospitalization
measure: Patient preferences for different providers and settings of mental health care services, as indicated by the percentage of patients who indicate actual receipt of or potential willingness to receive mental health care by specific providers and settings
timeFrame: Baseline and within one year after hospitalization
measure: Percentage of patients in need for depression health care according to existing recommendations
timeFrame: Baseline and within one year after hospitalization
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Medizinische Klinik m. Schwerpunkt Kardiologie, Charité Universitätsmedizin
Study officials:
affiliation: Charité Universitätsmedizin
name: Jacqueline Müller-Nordhorn, MD, DPH
role: PRINCIPAL_INVESTIGATOR
References: