NCT01626027

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,265

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2012

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2012

Completed
19 days until next milestone

First Submitted

Initial submission to the registry

June 20, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 22, 2012

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2015

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2016

Completed
Last Updated

August 2, 2016

Status Verified

August 1, 2016

Enrollment Period

3.2 years

First QC Date

June 20, 2012

Last Update Submit

August 1, 2016

Conditions

Keywords

Coronary Heart DiseaseDepressionHealth Care Services

Outcome Measures

Primary Outcomes (1)

  • 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)

    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

    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

    Baseline and within one year after hospitalization

  • Percentage of patients in need for depression health care according to existing recommendations

    Baseline and within one year after hospitalization

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • chronic CHD (confirmed by a clinician)

You may not qualify if:

  • chart-documented dementia disorder
  • cognitive impairment
  • life expectancy \< 1 year
  • unavailability for follow-up
  • insufficient proficiency in German or Turkish language

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Medizinische Klinik m. Schwerpunkt Kardiologie, Charité Universitätsmedizin

Berlin, State of Berlin, 13353, Germany

Location

MeSH Terms

Conditions

Coronary DiseaseDepression

Condition Hierarchy (Ancestors)

Myocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular DiseasesBehavioral SymptomsBehavior

Study Officials

  • Jacqueline Müller-Nordhorn, MD, DPH

    Charité Universitätsmedizin

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

June 20, 2012

First Posted

June 22, 2012

Study Start

June 1, 2012

Primary Completion

August 1, 2015

Study Completion

May 1, 2016

Last Updated

August 2, 2016

Record last verified: 2016-08

Locations