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

August 1, 2016 updated by: Jacqueline Müller-Nordhorn, Charite University, Berlin, Germany

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

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.

Study Overview

Status

Completed

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).

Study Type

Observational

Enrollment (Actual)

1265

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Berlin, Germany, 13353
        • Medizinische Klinik m. Schwerpunkt Kardiologie, Charité Universitätsmedizin

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of participants in depression care during the 12 months after hospitalization
Time Frame: Baseline and within one year 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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of participants reporting current utilization of mental health care and satisfaction with mental health care
Time Frame: Baseline and within one year after hospitalization

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
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
Time Frame: Baseline and within one year after hospitalization
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
Percentage of patients in need for depression health care according to existing recommendations
Time Frame: Baseline and within one year after hospitalization

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Jacqueline Müller-Nordhorn, MD, DPH, Charité Universitätsmedizin

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2012

Primary Completion (Actual)

August 1, 2015

Study Completion (Actual)

May 1, 2016

Study Registration Dates

First Submitted

June 20, 2012

First Submitted That Met QC Criteria

June 21, 2012

First Posted (Estimate)

June 22, 2012

Study Record Updates

Last Update Posted (Estimate)

August 2, 2016

Last Update Submitted That Met QC Criteria

August 1, 2016

Last Verified

August 1, 2016

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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