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

Not Applicable

Completed

• Conditions: Somatoform/functional complaints and disorders; Mental and Behavioural Disorders; Somatoform disorder

• Registration Number: ISRCTN27782834
• Lead Sponsor: German Federal Ministry of Education and Research (Bundesministerium Für Bildung und Forschung [BMBF])

Brief Summary

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)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2005-11-04
• Study Completion: 2006-05-03
• Last Update Posted: 1 July 2019

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 2000

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.

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Health care utilisation

Secondary Outcome Measures

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