Condition category
Mental and Behavioural Disorders
Date applied
18/10/2005
Date assigned
04/11/2005
Last edited
18/07/2008
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.funktional.uni-hd.de

Contact information

Type

Scientific

Primary contact

Prof Wolfgang Herzog

ORCID ID

Contact details

Thibautstr. 2
Heidelberg
69115
Germany
+49 (0)6221 56 7167
wolfgang_herzog@med.uni-heidelberg.de

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

Funktional-18-10-05

Study information

Scientific title

Acronym

FUNKTIONAL

Study hypothesis

A guideline-based training of general practitioners in early diagnosis and treatment of somatoform/functional complaints leads to improvements for general practitioners (GPs) as well as for patients:
1. Concerning the GPs we expect our intervention to be evaluated as efficient and enhancing competence. We expect the following changes in the trained intervention group in comparison with the waiting control group:
1.1. Change in GPs' attitude towards patients with somatoform/functional complaints
1.2. Higher provider satisfaction
2. Compared to the control group patients of the intervention group are expected to show the following improvements:
2.1. Less dysfunctional health care utilisation
2.2. Greater decrease in their symptomatology (severity and frequency of symptoms) in terms of somatization and comorbid mental disorders (depression, anxiety)
2.3. Better quality of life (QOL)
2.4. Better assessment of their GP's practice and higher patient satisfaction with their doctor
2.5. Extension of the patient's illness explanatory model towards a more biopsychosocial attribution to the illness
3. Regarding both, the GPs and the patients, we expect in the intervention group:
3.1. An improved communication between the GP and his/her patients
3.2. A better doctor-patient-relationship
4. Following a team-oriented approach, we additionally trained the practice nurses of the intervention group in dealing with difficult patients taking particular consideration in such with somatoform/functional complaints. Thereby we expect:
4.1. Change in practice nurses' attitudes towards difficult patients
4.2. A better cooperation between GPs and practice nurses

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

Not specified

Trial type

Treatment

Patient information sheet

Condition

Somatoform/functional complaints and disorders

Intervention

In this trial we evaluate a training programme for general practitioners in early diagnosis and treatment of functional/somatoform complaints and disorders. The training programme is called FUNKTIONAL-curriculum and was developed in a group of GPs and psychosomatic specialists in order to transform guideline based knowledge into practical skills in dealing with patients with somatoform/functional complaints. The training for the intervention group of 16 GPs extends over a period of 3 months and consists of four modules of 2 x 90 minutes each. 5 months later a 90 minute booster session takes place aiming at exchange of experiences and refreshment of the curriculum contents. The additional module for the practice nurses of the intervention group is arranged in one session over 2 x 90 minutes. The control group, a second group of 16 randomised general practitioners, initially only receives written information material about somatoform/functional disorders and will be trained after data collection.

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

Health care utilisation

Secondary outcome measures

1. Evaluation of the curriculum
2. GPs' attitudes towards somatisation and provider satisfaction
3. Doctor-patient relationship and patient satisfaction
4. Symptomatology:
4.1. Somatisation
4.2. Comorbidity: depression, anxiety
5. Patients' quality of life
6. Patients' explanatory model, illness perception
7. Practice nurses' attitudes towards difficult patients
8. Team-oriented approach: cooperation between GP and practice nurses

Overall trial start date

17/01/2005

Overall trial end date

03/05/2006

Reason abandoned

Eligibility

Participant inclusion criteria

The participating doctors are general practitioners from the Rhein-Neckar-region. They were stratified by practice location (urban/rural) and training in Psychosocial Primary Care (PPC) (yes/no) and randomly assigned to the intervention group or to the control group.

The following patients of these general practices were included in the study:
1. Aged 18 - 65 years
2. Patient has an appointment with the doctor (not only visits to the practice e.g. to fetch a prescription or to get the regular dose within a substitution therapy)

Among the participating general practitioners there are 16 GPs in the intervention group and 16 GPs in the control group. 2000 patients are to be screened in the practices; 1000 in the intervention group, 1000 in the control group. We expect about 30% to be screening- positive accordant to our criteria (see inclusion criteria). Accordingly, around 600 patients will have a high symptom load, 300 in the intervention group and 300 in the control group.

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

32 GPs; 2000 patients

Participant exclusion criteria

The following patients were excluded from the study:
1. Age younger than 18 years or older than 65 years
2. Patient has no appointment with the doctor (e.g. visits the practice only to fetch a prescription or to get the regular dose within a substitution therapy)
3. Insufficient German language skills (language barrier)
4. Illiteracy
5. Psychosis
6. Mental disability
7. Impairment by severe acute organic disease

Recruitment start date

17/01/2005

Recruitment end date

03/05/2006

Locations

Countries of recruitment

Germany

Trial participating centre

Thibautstr. 2
Heidelberg
69115
Germany

Sponsor information

Organisation

German Federal Ministry of Education and Research (Bundesministerium Für Bildung und Forschung [BMBF])

Sponsor details

Hannoversche Straße 28-30
Berlin
10115
Germany
+49 (0)1888 57 0
bmbf@bmbf.bund.de

Sponsor type

Government

Website

http://www.bmbf.de

Funders

Funder type

Government

Funder name

German Federal Ministry of Education and Research (Bundesministerium Für Bildung und Forschung [BMBF]) Grant Number GF GK 01072500

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

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

Publication citations

Additional files

Editorial Notes