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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
University Hospital Muenster
Information provided by (Responsible Party):
Jacqueline Müller-Nordhorn, Charite University, Berlin, Germany
ClinicalTrials.gov Identifier:
NCT01626027
First received: June 20, 2012
Last updated: July 29, 2015
Last verified: July 2015
  Purpose

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.


Condition
Coronary Heart Disease
Depression

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Depression Care for Hospitalized Coronary Heart Disease Patients: Bridging the Gap Between Guidelines and Reality

Resource links provided by NLM:


Further study details as provided by Charite University, Berlin, Germany:

Primary Outcome Measures:
  • Percentage of participants in depression care during the 12 months after hospitalization [ Time Frame: Baseline and within one year after hospitalization ] [ Designated as safety issue: No ]
    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 Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]

    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.



Estimated Enrollment: 1500
Study Start Date: June 2012
Estimated Study Completion Date: August 2015
Estimated Primary Completion Date: July 2015 (Final data collection date for primary outcome measure)
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).

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01626027

Locations
Germany
Medizinische Klinik m. Schwerpunkt Kardiologie, Charité Universitätsmedizin
Berlin, Germany, 13353
Sponsors and Collaborators
Charite University, Berlin, Germany
University Hospital Muenster
Investigators
Principal Investigator: Jacqueline Müller-Nordhorn, MD, DPH Charité Universitätsmedizin
  More Information

No publications provided

Responsible Party: Jacqueline Müller-Nordhorn, Professor, Charite University, Berlin, Germany
ClinicalTrials.gov Identifier: NCT01626027     History of Changes
Other Study ID Numbers: 01GY1154
Study First Received: June 20, 2012
Last Updated: July 29, 2015
Health Authority: Germany: Federal Ministry of Education and Research

Keywords provided by Charite University, Berlin, Germany:
Coronary Heart Disease
Depression
Health Care Services

Additional relevant MeSH terms:
Coronary Artery Disease
Coronary Disease
Depression
Depressive Disorder
Heart Diseases
Myocardial Ischemia
Arterial Occlusive Diseases
Arteriosclerosis
Behavioral Symptoms
Cardiovascular Diseases
Mental Disorders
Mood Disorders
Vascular Diseases

ClinicalTrials.gov processed this record on August 31, 2015