Depression Care for Hospitalized Coronary Heart Disease Patients: Prospective Cohort Study (CDCare)
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|ClinicalTrials.gov Identifier: NCT01626027|
Recruitment Status : Completed
First Posted : June 22, 2012
Last Update Posted : August 2, 2016
|Condition or disease|
|Coronary Heart Disease Depression|
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 :||Observational|
|Actual Enrollment :||1265 participants|
|Official Title:||Depression Care for Hospitalized Coronary Heart Disease Patients: Bridging the Gap Between Guidelines and Reality|
|Study Start Date :||June 2012|
|Actual Primary Completion Date :||August 2015|
|Actual Study Completion Date :||May 2016|
- 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)
- 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)
- 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").
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01626027
|Medizinische Klinik m. Schwerpunkt Kardiologie, Charité Universitätsmedizin|
|Berlin, Germany, 13353|
|Principal Investigator:||Jacqueline Müller-Nordhorn, MD, DPH||Charité Universitätsmedizin|