Condition category
Mental and Behavioural Disorders
Date applied
27/05/2005
Date assigned
10/06/2005
Last edited
05/08/2015
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

http://www.prompt-projekt.de

Contact information

Type

Scientific

Primary contact

Dr Jochen Gensichen

ORCID ID

Contact details

Theodor-Stern-Kai 7
Frankfurt a.M.
D - 60590
Germany
+49 (0)69 6301 83882
gensichen@allgemeinmedizin.uni-frankfurt.de

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

01Gk0302

Study information

Scientific title

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

Acronym

PRoMPT (PRimary care Monitoring for depressive Patients Trial)

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

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

GP practices

Trial type

Treatment

Patient information sheet

Condition

Major Depression

Intervention

Case Management including systematic telephone monitoring by the General Practice Team versus usual care

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

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 trial start date

01/05/2005

Overall trial end date

31/10/2006

Reason abandoned

Eligibility

Participant 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)

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

68 GP clinics including 10 patients each, N = 680

Participant exclusion criteria

1. Patients who cannot answer questionnaires independently
2. Patients who are terminally ill or could not speak German properly

Recruitment start date

01/05/2005

Recruitment end date

31/10/2006

Locations

Countries of recruitment

Germany

Trial participating centre

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

Sponsor information

Organisation

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

Sponsor details

Heinemannstr. 2
Bonn
D - 53227
Germany
+49 (0)228 3821 225
magret.knull@dlr.de

Sponsor type

Government

Website

Funders

Funder type

Government

Funder name

Bundesministerium für Bildung und Forschung

Alternative name(s)

Federal Ministry of Education and Research, BMBF

Funding Body Type

government organisation

Funding Body Subtype

federal

Location

Germany

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2005 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/16207375
2009 results in: http://www.ncbi.nlm.nih.gov/pubmed/19755362
2011 results in: http://www.ncbi.nlm.nih.gov/pubmed/21353124
2015 results in: http://www.ncbi.nlm.nih.gov/pubmed/25135191

Publication citations

  1. Protocol

    Gensichen J, Torge M, Peitz M, Wendt-Hermainski H, Beyer M, Rosemann T, Krauth C, Raspe H, Aldenhoff JB, Gerlach FM, Case management for the treatment of patients with major depression in general practices--rationale, design and conduct of a cluster randomized controlled trial--PRoMPT (PRimary care Monitoring for depressive Patient's Trial) [ISRCTN66386086]--study protocol., BMC Public Health, 2005, 5, 101, doi: 10.1186/1471-2458-5-101.

  2. Results

    Gensichen J, Petersen JJ, Karroum T, Rauck S, Ludman E, König J, Gerlach FM, Positive impact of a family practice-based depression case management on patient's self-management., Gen Hosp Psychiatry, 33, 1, 23-28, doi: 10.1016/j.genhosppsych.2010.11.007.

  3. Gensichen J, von Korff M, Peitz M, Muth C, Beyer M, Güthlin C, Torge M, Petersen JJ, Rosemann T, König J, Gerlach FM, , Case management for depression by health care assistants in small primary care practices: a cluster randomized trial., Ann. Intern. Med., 2009, 151, 6, 369-378.

  4. Results

    Petersen JJ, König J, Paulitsch MA, Mergenthal K, Rauck S, Pagitz M, Schmidt K, Haase L, Gerlach FM, Gensichen J, Long-term effects of a collaborative care intervention on process of care in family practices in Germany: a 24-month follow-up study of a cluster randomized controlled trial, Gen Hosp Psychiatry, 2014, 36, 6, 570-574, doi: 10.1016/j.genhosppsych.2014.07.006.

Additional files

Editorial Notes