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Completed

NCT Number: NCT01626027

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Medizinische Klinik m. Schwerpunkt Kardiologie, Charité Universitätsmedizin

Berlin, State of Berlin, 13353, Germany

About this study

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:

  • to assess the current use of depression care in CHD patients who are hospitalized or receive ambulatory care at a cardiology clinic
  • 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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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)

Secondary outcomes

  1. 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)

  2. 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").

  3. 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.

Sponsors and collaborators

Lead sponsor

Charite University, Berlin, Germany

Other

Collaborators

  • University Hospital Muenster

Registry information

Official study title

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

Acronym: CDCare

Important dates

Study start
2012
Primary completion
2015
Study completion
2016
First posted
Jun 22, 2012
Registry last updated
Aug 2, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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