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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01879111
Other study ID # 01-GX-1004
Secondary ID DRKS00003277
Status Completed
Phase N/A
First received
Last updated
Start date October 2011
Est. completion date May 2014

Study information

Verified date November 2020
Source Universitätsklinikum Hamburg-Eppendorf
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Out-patients with coronary heart disease or hypertension will fill out a depression screening questionnaire while waiting in a cardiac clinic. Using a randomised-controlled study design half of the patients will receive a patient-targeted written screening feedback. This feedback contains information about depression in general, depression-severity adapted treatment guidelines and contact-information for treatment. Patients in the control group receive no direct screening-feedback but their cardiologist will be informed about the screening result. All patients with a positive screening-result will be contacted after one month and six months and asked for symptoms of depression, and their use of health care. The aim of this study is to evaluate the efficiency of this minimal intervention on the course of depressive symptom in patients with known coronary heart disease or hypertension.


Description:

The aim of this study is to evaluate the efficiency of a minimal intervention on the course of depressive symptoms in patients with known coronary heart disease (CHD) or hypertension. By means of a depression screening and individual patient-targeted feedback the level of depression should decrease, the percentage of treated depressed patients should increase and health economic costs should be lowered. The main hypothesis is that screening plus targeted feedback results in a greater reduction of depression than screening only.


Recruitment information / eligibility

Status Completed
Enrollment 4151
Est. completion date May 2014
Est. primary completion date October 2013
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Gender: Both, male and female - Minimum Age: 18 Years - Maximum Age: no maximum age - Attendance in a cardiac clinic; - Clinical diagnosis of coronary heart disease or hypertension; - Age = 18 years; - Sufficient language skills; - Informed consent Exclusion Criteria: - Life threatening health status; - Severe somatic or/and psychological disorder that needs urgent treatment; - Acute suicidal tendency; - Severe cognitive or/and visual difficulties; - Not being able to fill out questionnaires

Study Design


Intervention

Other:
patient-targeted feedback
Using a randomised-controlled study design half of the patients will receive a patient-targeted written screening feedback. This feedback contains information about depression in general, depression-severity adapted treatment guidelines and contact-information for treatment.

Locations

Country Name City State
Germany Cardiologicum Hamburg Hamburg
Germany University Medical Center Universitaeres Herzzentrum Hamburg-Eppendorf Hamburg

Sponsors (2)

Lead Sponsor Collaborator
Universitätsklinikum Hamburg-Eppendorf German Federal Ministry of Education and Research

Country where clinical trial is conducted

Germany, 

Outcome

Type Measure Description Time frame Safety issue
Primary Level of depression one month after screening (Patient Health Questionnaire-9) One month after depression screening
Secondary Level of depression six months after screening (Patient Health Questionnaire-9) One month and six months after screening
Secondary Proportion of patients treated for depression. One month and six months after screening
Secondary Direct and indirect health costs One month and six months after screening
Secondary Quality-adjusted years of life and quality of life (EuroQol-5D) One month and six months after screening
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