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Case Management for the treatment of patients with Major Depression in General Practices
ISRCTN ISRCTN66386086
DOI 10.1186/ISRCTN66386086
ClinicalTrials.gov identifier
EudraCT number
Public title Case Management for the treatment of patients with Major Depression in General Practices
Scientific title
Acronym PRoMPT (PRimary care Monitoring for depressive Patients Trial)
Serial number at source 01Gk0302
Study hypothesis General practices based Case Management for patients with major depression reaches compared to a treatment without case management an improvement of the patients outcome (depression).
Lay summary Not provided at time of registration
Ethics approval Not provided at time of registration
Study design Randomised controlled trial
Countries of recruitment Germany
Disease/condition/study domain Major Depression
Participants - inclusion criteria 1. Diagnosis Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM IV) "Major Depression" as per Patient Health Questionnaire Depression (PHQ-D) screening
2. Anti-depressive therapy
3. Medical care by a family doctor
4. Age 18-80
5. Capability to voluntary, informed participation in research (written confirmation)
Participants - exclusion criteria 1. Patients who cannot answer questionnaires independently
2. Patients who are terminally ill or could not speak German properly
Anticipated start date 01/05/2005
Anticipated end date 31/10/2006
Status of trial Completed
Patient information material
Target number of participants 68 GP clinics including 10 patients each, N = 680
Interventions Case Management including systematic telephone monitoring by the General Practice Team versus usual care
Primary outcome measure(s) Major Depression: Status of depression in patient health questionnaire (PHQ-D, Löwe 2001)
Secondary outcome measure(s) 1. Adherence of patient to therapy (self-report by patient)
2. Quality of life (QoL) (SF 36, Bullinger 1987)
3. Costs
Sources of funding Federal Ministry of Education and Research (Bundesministerium Für Bildung und Forschung) (BMBF) / German Aerospace Centre (Deutschen Zentrum für Luft- und Raumfahrt) (DLR)
Trial website http://www.prompt-projekt.de
Publications 1. 2005 protocol in http://www.ncbi.nlm.nih.gov/pubmed/16207375
2. 2009 results in http://www.ncbi.nlm.nih.gov/pubmed/19755362
3. 2011 results in http://www.ncbi.nlm.nih.gov/pubmed/21353124
Contact name Dr  Jochen  Gensichen
  Address Theodor-Stern-Kai 7
  City/town Frankfurt a.M.
  Zip/Postcode D - 60590
  Country Germany
  Tel +49 (0)69 6301 83882
  Fax +49 (0)69 6301 6428
  Email gensichen@allgemeinmedizin.uni-frankfurt.de
Sponsor Federal Ministry of Education and Research (BMBF) / German Aerospace Center (DLR) (Germany)
  Address Heinemannstr. 2
  City/town Bonn
  Zip/Postcode D - 53227
  Country Germany
  Tel +49 (0)228 3821 225
  Fax +49 (0)228 3821 257
  Email magret.knull@dlr.de
Date applied 27/05/2005
Last edited 28/07/2011
Date ISRCTN assigned 10/06/2005
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