Increasing the Efficiency of Depression-screening Using Patient-targeted Feedback

Not Applicable

Completed

• Conditions: Chronic Ischaemic Heart Disease; Hypertension; Depressive Episode
• Interventions: Other: patient-targeted feedback

• Registration Number: NCT01879111
• Lead Sponsor: Universitätsklinikum Hamburg-Eppendorf

Brief 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.

Detailed 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.

Study Timeline

• Study Start: 2011-10
• Study First Submitted: 2013-06-12
• Study First Submitted QC: 2013-06-14
• Study First Posted: 2013-06-17
• Primary Completion: 2013-10
• Study Completion: 2014-05
• Status Verified: 2020-11
• Last Update Submitted: 2020-11-16
• Last Update Posted: 2020-11-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 4151

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

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
state-of-art depression screening + patient-targeted feedback	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.

Primary Outcome Measures

Name	Time	Method
Level of depression one month after screening (Patient Health Questionnaire-9)	One month after depression screening

Secondary Outcome Measures

Name	Time	Method
Level of depression six months after screening (Patient Health Questionnaire-9)	One month and six months after screening
Proportion of patients treated for depression.	One month and six months after screening
Direct and indirect health costs	One month and six months after screening
Quality-adjusted years of life and quality of life (EuroQol-5D)	One month and six months after screening

Trial Locations

Locations (2)

University Medical Center Universitaeres Herzzentrum Hamburg-Eppendorf; 🇩🇪 Hamburg, Germany

Cardiologicum Hamburg; 🇩🇪 Hamburg, Germany