Coronary Heart DiseaseCDCareNCT01626027
Depression Care for Hospitalized Coronary Heart Disease Patients: Prospective Cohort Study
An observational study of Coronary Heart Disease and Depression, run by Charite University, Berlin, Germany at 1 site in Germany.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Heart Disease, Depression
- How many people
- 1,265 participants
- Where
- 1 siteGermany
- Study dates
- Jun 2012to May 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- chronic CHD (confirmed by a clinician)
Who cannot join
- chart-documented dementia disorder
- cognitive impairment
- life expectancy < 1 year
- unavailability for follow-up
- insufficient proficiency in German or Turkish language
Trial locations and contacts
1 site in 1 country.
Germany1 site
Medizinische Klinik m. Schwerpunkt Kardiologie, Charité Universitätsmedizin
Berlin, State of Berlin, 13353
About this study
Official title: 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.
Read the 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).
- Conditions
- Coronary Heart Disease, Depression
- Keywords
- Coronary Heart Disease, Depression, Health Care Services
- Medical subject headings
- Coronary Disease, Depression
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of participants in depression care during the 12 months 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)
Measured: Baseline and within one year after hospitalization
Secondary outcomes (3)
Percentage of participants reporting current utilization of mental health care and satisfaction with mental health care
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)
Measured: 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
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").
Measured: Baseline and within one year after hospitalization
Percentage of patients in need for depression health care according to existing recommendations
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.
Measured: Baseline and within one year after hospitalization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2012 (estimated)
- Study startJun 2012
- Primary completionAug 2015
- Study completionMay 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Heart DiseaseStudies of the same condition, open and under way.
- More trials run by Charite University, Berlin, GermanyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,265 participants (actual)
Sponsor and investigators
- Lead sponsor
- Charite University, Berlin, Germany
- Sponsor type
- University, hospital or other
- Collaborators
- University Hospital Muenster
- Responsible party
- Principal investigator, Jacqueline Müller-Nordhorn, Charite University, Berlin, Germany
- Investigators
- Jacqueline Müller-Nordhorn, MD, DPH, Principal investigator, Charité Universitätsmedizin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01626027
- Sponsor's protocol ID
- 01GY1154
- Acronym
- CDCare
- Status last verified
- Aug 2016
- First submitted
- 20 Jun 2012
- Last updated
- 2 Aug 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 2 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Depression Care for Hospitalized Coronary Heart Disease Patients: Bridging the Gap Between Guidelines and Reality
- ClinicalTrials.gov ID
- NCT01626027
- Acronym / sponsor ID
- CDCare / 01GY1154
- Conditions
- Coronary Heart Disease, Depression
- Keywords
- Coronary Heart Disease, Depression, Health Care Services
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,265 participants (actual)
- Lead sponsor
- Charite University, Berlin, GermanyUniversity, hospital or other
- Collaborators
- University Hospital Muenster
- Study start
- Jun 2012
- Primary completion
- Aug 2015 (actual)
- Study completion
- May 2016 (actual)
- First posted
- 22 Jun 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- chronic CHD (confirmed by a clinician)
Key exclusion criteria (5 listed)
- chart-documented dementia disorder
- cognitive impairment
- life expectancy < 1 year
- unavailability for follow-up
- insufficient proficiency in German or Turkish language
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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)
3 secondary outcomes
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
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
Percentage of patients in need for depression health care according to existing recommendations
Time frame: Baseline and within one year after hospitalization
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Aug 2016.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jacqueline Müller-Nordhorn, MD, DPH principal investigator
Charité Universitätsmedizin
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Coronary Heart Disease and Depression, run by Charite University, Berlin, Germany at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Aug 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of participants in depression care during the 12 months after hospitalization (time frame: Baseline and within one year after hospitalization). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Aug 2016.