Case Management for the treatment of patients with Major Depression in General Practices

ISRCTN	ISRCTN66386086
DOI	https://doi.org/10.1186/ISRCTN66386086
Secondary identifying numbers	01Gk0302

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Dr Jochen Gensichen
Scientific

Theodor-Stern-Kai 7
Frankfurt a.M.
D - 60590
Germany

Phone	+49 (0)69 6301 83882
Email	gensichen@allgemeinmedizin.uni-frankfurt.de

Study design	Randomised controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	GP practice
Study type	Treatment
Scientific title	Case Management for the treatment of patients with Major Depression in General Practices
Study acronym	PRoMPT (PRimary care Monitoring for depressive Patients Trial)
Study objectives	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(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	Major Depression
Intervention	Case Management including systematic telephone monitoring by the General Practice Team versus usual care
Intervention type	Other
Primary outcome measure	Major Depression: Status of depression in patient health questionnaire (PHQ-D, Löwe 2001)
Secondary outcome measures	1. Adherence of patient to therapy (self-report by patient) 2. Quality of life (QoL) (SF 36, Bullinger 1987) 3. Costs
Overall study start date	01/05/2005
Completion date	31/10/2006

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Upper age limit	80 Years
Sex	Both
Target number of participants	68 GP clinics including 10 patients each, N = 680
Key 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)
Key exclusion criteria	1. Patients who cannot answer questionnaires independently 2. Patients who are terminally ill or could not speak German properly
Date of first enrolment	01/05/2005
Date of final enrolment	31/10/2006

Theodor-Stern-Kai 7

Frankfurt a.M.
D - 60590
Germany

Federal Ministry of Education and Research (BMBF) / German Aerospace Center (DLR) (Germany)
Government

Heinemannstr. 2
Bonn
D - 53227
Germany

Government

Bundesministerium für Bildung und Forschung
Government organisation / National government

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Output type	Details	Date created	Peer reviewed?	Patient-facing?
Protocol article	protocol	05/10/2005	Yes	No
Results article	results	15/09/2009	Yes	No
Results article	results	01/01/2011	Yes	No
Results article	results	01/11/2015	Yes	No