|
ISRCTN
|
ISRCTN66386086
|
|
ClinicalTrials.gov identifier
|
|
|
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).
|
|
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
|
|
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
|
21/09/2009
|
|
Date ISRCTN assigned
|
10/06/2005
|
