- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01626027
Depression Care for Hospitalized Coronary Heart Disease Patients: Prospective Cohort Study (CDCare)
Depression Care for Hospitalized Coronary Heart Disease Patients: Bridging the Gap Between Guidelines and Reality
Study Overview
Status
Conditions
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:
- 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).
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Berlin, Germany, 13353
- Medizinische Klinik m. Schwerpunkt Kardiologie, Charité Universitätsmedizin
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
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
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
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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)
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Baseline and within one year after hospitalization
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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
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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
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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
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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").
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Baseline and within one year after hospitalization
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Percentage of patients in need for depression health care according to existing recommendations
Time Frame: Baseline and within one year after hospitalization
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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
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Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Jacqueline Müller-Nordhorn, MD, DPH, Charité Universitätsmedizin
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 01GY1154
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
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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