Depression Care for Hospitalized Coronary Heart Disease Patients: Prospective Cohort Study

Depression Clinical Trial

— CDCare  

Official title:

Depression Care for Hospitalized Coronary Heart Disease Patients: Bridging the Gap Between Guidelines and Reality

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01626027
• Other study ID #: 01GY1154
• Status: Completed
• Phase: N/A
• First received: June 20, 2012
• Last updated: August 1, 2016
• Start date: June 2012
• Est. completion date: May 2016

Study information

• Verified date: August 2016
• Source: Charite University, Berlin, Germany
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Ministry of Education and Research
• Study type: Observational

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1265
• Est. completion date: May 2016
• Est. primary completion date: August 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Coronary Heart Disease
• Depression
• Depressive Disorder
• Heart Diseases
• Myocardial Ischemia

Locations

Country	Name	City	State
Germany	Medizinische Klinik m. Schwerpunkt Kardiologie, Charité Universitätsmedizin	Berlin

Sponsors (2)

Lead Sponsor	Collaborator
Charite University, Berlin, Germany	University Hospital Muenster

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of participants in depression care during the 12 months after hospitalization	Assessed via questionnaire (self-reported psychotherapy for depression and / or antidepressant medication and / or other treatment) at baseline, 1month, 6 month and 12 months Additionally, antidepressant medication prescription will be assessed at baseline via chart review (antidepressant medication at admission and discharge)	Baseline and within one year after hospitalization	No
Secondary	Percentage of participants reporting current utilization of mental health care and satisfaction with mental health care	Current mental health care utilization is assessed via questionnaire with a single item ("yes or no").; Satisfaction with current mental health care is assessed via questionnaire with a single continuous rating item (ranging from "very satisfied to not at all satisfied") at baseline and all follow-up assessments (1mo, 6mo and 12months)	Baseline and within one year after hospitalization	No
Secondary	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	Assessed via questionnaire with at baseline and all follow-up assessments (1mo, 6mo and 12months). A list of mental health care providers (e.g., general practitioner, psychotherapist, psychiatrist, ...) is provided and for each, patients are asked to indicated whether they currently receive mental health care from any provider and if not, if they would be willing to reciev mentral health care by that provider, should they ever be in need (answer options "yes, maybe, no").	Baseline and within one year after hospitalization	No
Secondary	Percentage of patients in need for depression health care according to existing recommendations	Baseline: Percentage of patients with a current Major Depressive Episode as assessed via the Composite International Diagnostic Interview (CIDI).; 6 months assessment: percentage of patients with a current Major Depressive Episode as assessed via the Composite International Diagnostic Interview (CIDI) - this will only be conducted in a subsample of 300 consecutive participants.; Follow-up assessments: percentage of patients with persistently elevated depressive symptoms as indicated by a score of >=10 on the Patient Health Questionnaire (PHQ-9) at baseline and the follow-up assessments.	Baseline and within one year after hospitalization	No