FUNKTIONAL - Cluster randomised controlled evaluation of a guideline-based curriculum for early diagnosis and treatment of somatoform/functional disorders in general practice

ISRCTN ISRCTN27782834
DOI https://doi.org/10.1186/ISRCTN27782834
Secondary identifying numbers Funktional-18-10-05
Submission date
18/10/2005
Registration date
04/11/2005
Last edited
11/06/2019
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Mental and Behavioural Disorders
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

Not provided at time of registration

Study website

Contact information

Prof Wolfgang Herzog
Scientific

Thibautstr. 2
Heidelberg
69115
Germany

Phone +49 (0)6221 56 7167
Email wolfgang_herzog@med.uni-heidelberg.de

Study information

Study designRandomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Not specified
Study typeTreatment
Scientific titleFUNKTIONAL - Cluster randomised controlled evaluation of a guideline-based curriculum for early diagnosis and treatment of somatoform/functional disorders in general practice
Study acronymFUNKTIONAL
Study objectivesA 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(s)Not provided at time of registration
Health condition(s) or problem(s) studiedSomatoform/functional complaints and disorders
InterventionIn 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 typeOther
Primary outcome measureHealth care utilisation
Secondary outcome measures1. 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 study start date17/01/2005
Completion date03/05/2006

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
SexBoth
Target number of participants32 GPs; 2000 patients
Key inclusion criteriaThe 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.
Key exclusion criteriaThe 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
Date of first enrolment17/01/2005
Date of final enrolment03/05/2006

Locations

Countries of recruitment

  • Germany

Study participating centre

Thibautstr. 2
Heidelberg
69115
Germany

Sponsor information

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

Hannoversche Straße 28-30
Berlin
10115
Germany

Phone +49 (0)1888 57 0
Email bmbf@bmbf.bund.de
Website http://www.bmbf.de
ROR logo "ROR" https://ror.org/04pz7b180

Funders

Funder type

Government

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

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article results 01/06/2005 11/06/2019 Yes No
Results article results 01/06/2005 11/06/2019 Yes No

Editorial Notes

11/06/2019: Publication reference added.