Improving the detection of psychosomatic co-morbidity in general practice - a pilot project
Organizational Data
- DRKS-ID:
- DRKS00006001
- Recruitment Status:
- Recruiting complete, study complete
- Date of registration in DRKS:
- 2014-03-19
- Last update in DRKS:
- 2015-12-07
- Registration type:
- Retrospective
Acronym/abbreviation of the study
No Entry
URL of the study
No Entry
Brief summary in lay language
Many studies highlight the impact of psychosomatic comorbidity on health care utilisation in general practice. Patients with depression, anxiety and somatisation are frequently contacting their general practitioners and specialists and have more days of disability than patients without psychosomatic comorbidity. These patients remain under-recognised despite the high relevance for patient management in primary care. We aim to develop an educational intervention for general practitioners to improve the communication and detection rate of patients with enhanced psychosomatic comorbidity. This is designed as a pilot project. Six practices with an educational intervention will be compared with six practices without intervention (usual care). Patients will fill in a psychometric questionnaire in the waiting room (t1) and three months after inclusion (t2). The general practitioner will rate the psychosomatic comorbidity of the patient after the consultation on a visual analogue scale (VAS) from 0 to 10. We aim to include 20 patients per practice, in total 240 patients (with follow-up). We will compare the correlations between the general practitioners estimation of the psychosomatic comorbidity of their patients and the patients´ self-rating (intervention group versus usual care).
Brief summary in scientific language
Background: Many studies highlight the impact of psychosomatic comorbidity on health care utilisation in general practice. Patients with depression, anxiety and somatisation are frequently contacting their general practitioners and specialists and have more days of disability than patients without psychosomatic comorbidity. These patients remain under-recognised despite the high relevance for patient management in primary care. Aim: To develop an educational intervention for general practitioners to improve the communication and detection rate of patients with enhanced psychosomatic comorbidity. This is designed as a pilot project. Design: Cluster randomised controlled trial with twelve general practices. Six practices with an educational intervention will be compared with six practices without intervention (usual care). Patients will fill in a psychometric questionnaire in the waiting room (t1) and three months after inclusion (t2). The general practitioner will rate the psychosomatic comorbidity of the patient after the consultation on a visual analogue scale (VAS) from 0 to 10. We aim to include 20 patients per practice, in total 240 patients (with follow-up). Questionnaire: Patient Health Questionnaire (PHQ-D, German version), Big-Five-Inventory, Autonomy Preference Index. Analysis: Descriptive and explorative analysis. Comparison of correlation coefficients between the general practitioners estimation of the psychosomatic comorbidity of their patients and the patients´ self-rating (intervention group versus usual care)
Health condition or problem studied
- ICD10:
- F32.1 - Moderate depressive episode
- ICD10:
- F45.0 - Somatization disorder
- Healthy volunteers:
- No Entry
Interventions, Observational Groups
- Arm 1:
- Educational intervention (to optimise communication with patients suspected to suffer from psychosomatic co-morbidity; to improve diagnostic competencies; to enhance detection rate of psychosomatic co-morbidity)
- Arm 2:
- usual care
Endpoints
- Primary outcome:
- Detection rate of psychosomatic co-morbidity
- Secondary outcome:
- No secondary oucomes.
Study Design
- Purpose:
- Diagnostic
- Allocation:
- Randomized controlled study
- Control:
-
- Other
- Phase:
- N/A
- Study type:
- Interventional
- Mechanism of allocation concealment:
- No Entry
- Blinding:
- No
- Assignment:
- Parallel
- Sequence generation:
- No Entry
- Who is blinded:
- No Entry
Recruitment
- Recruitment Status:
- Recruiting complete, study complete
- Reason if recruiting stopped or withdrawn:
- No Entry
Recruitment Locations
- Recruitment countries:
-
- Germany
- Number of study centers:
- Multicenter study
- Recruitment location(s):
- No Entry
Recruitment period and number of participants
- Planned study start date:
- No Entry
- Actual study start date:
- 2014-03-10
- Planned study completion date:
- No Entry
- Actual Study Completion Date:
- No Entry
- Target Sample Size:
- 240
- Final Sample Size:
- No Entry
Inclusion Criteria
- Sex:
- All
- Minimum Age:
- 18 Years
- Maximum Age:
- no maximum age
- Additional Inclusion Criteria:
- At least 18 years, Ability to read German language, Agreement to the study
Exclusion Criteria
younger than 18 years, not able to read German language
Addresses
Primary Sponsor
- Address:
- Institut für AllgemeinmedizinProf. Dr. med. Antonius SchneiderOrleansstr. 4781667 MünchenGermany
- Telephone:
- 089/614658911
- Fax:
- 089/614658915
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- http://www.am.med.tum.de
- Investigator Sponsored/Initiated Trial (IST/IIT):
- Yes
Contact for Scientific Queries
- Address:
- Institut für AllgemeinmedizinKlinikum rechts der Isar, TU MünchenProf. Dr. med. Antonius SchneiderOrleansstr. 4781667 MünchenGermany
- Telephone:
- 089/614658911
- Fax:
- 089/614658915
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- http://www.am.med.tum.de
Contact for Public Queries
- Address:
- Institut für AllgemeinmedizinKlinikum rechts der IsarTU MünchenProf. Dr. med. Antonius SchneiderOrleansstr. 4781667 MünchenGermany
- Telephone:
- 089/614658911
- Fax:
- 089/614658915
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- http://www.am.med.tum.de
Principal Investigator
- Address:
- Institut für AllgemeinmedizinKlinikum rechts der Isar, TU MünchenProf. Dr. med. Antonius SchneiderOrleansstr. 4781667 MünchenGermany
- Telephone:
- 089/614658911
- Fax:
- 089/614658915
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- http://www.am.med.tum.de
Sources of Monetary or Material Support
Institutional budget, no external funding (budget of sponsor/PI)
- Address:
- Institut für AllgemeinmedizinOrleansstr. 4781667 MünchenGermany
- Telephone:
- 089/614658911
- Fax:
- 089/614658915
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- http://www.am.med.tum.de
Ethics Committee
Address Ethics Committee
- Address:
- Ethikkommission der Fakultät für Medizin der Technischen Universität MünchenIsmaninger Str. 2281675 MünchenGermany
- Telephone:
- +49-89-41404371
- Fax:
- +49-89-41404199
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- No Entry
Vote of leading Ethics Committee
- Vote of leading Ethics Committee
- Date of ethics committee application:
- 2014-01-13
- Ethics committee number:
- 15/14
- Vote of the Ethics Committee:
- Approved
- Date of the vote:
- 2014-02-18
Further identification numbers
- Other primary registry ID:
- No Entry
- EudraCT Number:
- No Entry
IPD - Individual Participant Data
- Do you plan to make participant-related data (IPD) available to other researchers in an anonymized form?:
- No Entry
- IPD Sharing Plan:
- No Entry
Study protocol and other study documents
- Study protocols:
- No Entry
- Study abstract:
- No Entry
- Other study documents:
- No Entry
- Background literature:
- No Entry
- Related DRKS studies:
- No Entry
Publication of study results
- Planned publication:
- No Entry
- Publikationen/Studienergebnisse:
- No Entry
- Date of first publication of study results:
- No Entry
- DRKS entry published for the first time with results:
- No Entry
Basic reporting
- Basic Reporting / Results tables:
- No Entry
- Brief summary of results:
- No Entry