Plain English Summary
Not provided at time of registration
Trial website
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
FUNKTIONAL - Cluster randomised controlled evaluation of a guideline-based curriculum for early diagnosis and treatment of somatoform/functional disorders in general practice
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 measure
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 (if study stopped)
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
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
Basic results (scientific)
Publication list
1. 2005 results in: DOI: 10.1055/s-2006-932384 (added 11/06/2019)
2. 2005 results in: DOI: 10.1055/s-2005-836349 (added 11/06/2019)