Increasing the Efficiency of Depression-screening Using Patient-targeted Feedback (DEPSCREEN-INFO)

This study has been completed.
Sponsor:
Collaborator:
German Federal Ministry of Education and Research
Information provided by (Responsible Party):
Universitätsklinikum Hamburg-Eppendorf
ClinicalTrials.gov Identifier:
NCT01879111
First received: June 12, 2013
Last updated: September 8, 2014
Last verified: September 2014
  Purpose

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.


Condition Intervention
Depressive Episode
Chronic Ischaemic Heart Disease
Hypertension
Other: patient-targeted feedback

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Screening
Official Title: Increasing the Efficiency of Depression-screening Using Patient-targeted Feedback: Randomized Controlled Trial

Resource links provided by NLM:


Further study details as provided by Universitätsklinikum Hamburg-Eppendorf:

Primary Outcome Measures:
  • Level of depression one month after screening (Patient Health Questionnaire-9) [ Time Frame: One month after depression screening ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Level of depression six months after screening (Patient Health Questionnaire-9) [ Time Frame: One month and six months after screening ] [ Designated as safety issue: No ]
  • Proportion of patients treated for depression. [ Time Frame: One month and six months after screening ] [ Designated as safety issue: No ]
  • Direct and indirect health costs [ Time Frame: One month and six months after screening ] [ Designated as safety issue: No ]
  • Quality-adjusted years of life and quality of life (EuroQol-5D) [ Time Frame: One month and six months after screening ] [ Designated as safety issue: No ]

Enrollment: 4151
Study Start Date: July 2012
Study Completion Date: May 2014
Primary Completion Date: October 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: state-of-art depression screening + 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.
Other: patient-targeted feedback
No Intervention: state-of-art depression screening

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.

  Eligibility

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

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
  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: NCT01879111

Locations
Germany
University Medical Center Universitaeres Herzzentrum Hamburg-Eppendorf
Hamburg, Germany, 20246
Cardiologicum Hamburg
Hamburg, Germany, 22041
Sponsors and Collaborators
Universitätsklinikum Hamburg-Eppendorf
German Federal Ministry of Education and Research
Investigators
Principal Investigator: Bernd Loewe, MD Universitätsklinikum Hamburg-Eppendorf
  More Information

Additional Information:
No publications provided

Responsible Party: Universitätsklinikum Hamburg-Eppendorf
ClinicalTrials.gov Identifier: NCT01879111     History of Changes
Other Study ID Numbers: 01-GX-1004, DRKS00003277
Study First Received: June 12, 2013
Last Updated: September 8, 2014
Health Authority: Germany: Federal Ministry of Education and Research

Keywords provided by Universitätsklinikum Hamburg-Eppendorf:
Depressive episode
Chronic ischaemic heart disease
Hypertension

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

ClinicalTrials.gov processed this record on September 22, 2014