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

Sponsor
Universitätsklinikum Hamburg-Eppendorf (Other)
Overall Status
Completed
CT.gov ID
NCT01879111
Collaborator
German Federal Ministry of Education and Research (Other)
4,151
2
2
31
2075.5
67

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: patient-targeted feedback
N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
4151 participants
Allocation:
Randomized
Intervention Model:
Factorial Assignment
Masking:
Single (Outcomes Assessor)
Primary Purpose:
Screening
Official Title:
Increasing the Efficiency of Depression-screening Using Patient-targeted Feedback: Randomized Controlled Trial
Study Start Date :
Oct 1, 2011
Actual Primary Completion Date :
Oct 1, 2013
Actual Study Completion Date :
May 1, 2014

Arms and Interventions

Arm Intervention/Treatment
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
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.

No Intervention: state-of-art depression screening

Outcome Measures

Primary Outcome Measures

  1. Level of depression one month after screening (Patient Health Questionnaire-9) [One month after depression screening]

Secondary Outcome Measures

  1. Level of depression six months after screening (Patient Health Questionnaire-9) [One month and six months after screening]

  2. Proportion of patients treated for depression. [One month and six months after screening]

  3. Direct and indirect health costs [One month and six months after screening]

  4. Quality-adjusted years of life and quality of life (EuroQol-5D) [One month and six months after screening]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Locations

Site City State Country Postal Code
1 University Medical Center Universitaeres Herzzentrum Hamburg-Eppendorf Hamburg Germany 20246
2 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

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

None provided.
Responsible Party:
Universitätsklinikum Hamburg-Eppendorf
ClinicalTrials.gov Identifier:
NCT01879111
Other Study ID Numbers:
  • 01-GX-1004
  • DRKS00003277
First Posted:
Jun 17, 2013
Last Update Posted:
Nov 18, 2020
Last Verified:
Nov 1, 2020
Keywords provided by Universitätsklinikum Hamburg-Eppendorf
Additional relevant MeSH terms:

Study Results

No Results Posted as of Nov 18, 2020