Trial document




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  DRKS00019086

Trial Description

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Title

Basic community mental health care for people with severe mental illnesses

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Trial Acronym

GBV

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URL of the Trial

http://www.gbv.online

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Brief Summary in Lay Language

The strong fragmentation of the health care system, i.e. the division of care services between separate social service providers with various, separate remuneration systems, leads to a large number of service providers working unconnectedly side by side. In the context of this project, basic community psychiatric care (GBV) for people with severe mental illnesses shall be introduced and investigated. Within the framework of the GBV, community-based multi-professional teams, which have an anchor and pilot function for the affected persons and their relatives, will plan, network and guide the totality of care services together with the affected people.
The study takes place in twelve regions in Germany. As part of the study, 1000 patients with severe mental illnesses will be interviewed over a period of two years at five occasions every six months. The study covers information on the state of health, quality of life and the patients' assessment of their independence in their lifestyle. In addition, all medical and psychotherapeutic treatment services used will be assessed. The study is controlled, i.e. there are two possible study groups: one study group receives treatment as usual (TAU), the other study group receives GBV in addition to standard care. In order to avoid any bias of the study results due to systematic selection effects, a random allocation to the two study groups will be applied.

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Brief Summary in Scientific Language

Basic community psychiatric care (GBV) is based on the British Community Mental Health Teams (CMHT) and the Dutch Flexible Assertive Community Treatment (FACT) model. In addition, the program offers crisis intervention services (assertive outreach).
The project aims to analyse the effectiveness and cost-effectiveness of GBV compared to treatment as usual in a randomised, controlled study with five assessments over a period of two years.
In twelve regions in Germany, 1000 patients with a mental illness of the ICD-10 diagnosis groups F2, F3, F4, F5 or F6 will be recruited. The participation is possible only if a screening assessment reveals an indication for GBV.
The primary outcome is the improvement of empowerment. Further outcomes are the improvement of treatment satisfaction and subjective quality of life, the reduction of unmet needs and illness-related clinical and social impairment of patients, as well as the improvement of the cost-effectiveness ratio of the resources used (both from the perspective of statutory health insurances and national economy).
In addition, the effects of GBV on the burden and quality of life of relatives and close caregivers of patients will be investigated.

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Do you plan to share individual participant data with other researchers?

Yes

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Description IPD sharing plan:

Only anonymized data will be made shared. For this reason, the shared dataset will be restricted to key variables and derived key figures, while single items of questionnaires will be excluded.
The shared data will follow FAIR-principles. Next to the study protocol and the statistical analysis plan, a data dictionary including meta data will be shared.
Some key variables will be open access, others will be available on request only.

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Organizational Data

  •   DRKS00019086
  •   2020/01/03
  •   [---]*
  •   yes
  •   Approved
  •   259/19, Ethik-Kommission der Universität Ulm
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Secondary IDs

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Health Condition or Problem studied

  •   F20 -  Schizophrenia
  •   F30 -  Manic episode
  •   F40 -  Phobic anxiety disorders
  •   F50 -  Eating disorders
  •   F60 -  Specific personality disorders
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Interventions/Observational Groups

  •   The intervention group consists of 500 patients with severe mental illness who receive GBV in addition to standard care.
  •   The control group consists of 500 patients with severe mental illness who only get treatment as usual.
  •   Furthermore, family members or close relatives of the participating patients will be interviewed.
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Characteristics

  •   Interventional
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  •   Randomized controlled trial
  •   Open (masking not used)
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  •   Active control (effective treament of control group)
  •   Treatment
  •   Parallel
  •   N/A
  •   N/A
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Primary Outcome

change in empowerment total score (EPAS) over 24 months

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Secondary Outcome

Patients; assessments at 0 months / 6 months / 12 months / 18 months / 24 months:
- Improvement of satisfaction with care (ZUF8)
- Improvement of the subjective quality of life (WHOQOL-BREF)
- Reduction of unmet care needs (CAN) and disease-related clinical and social impairment (HoNOS)
- Improvement of the cost-effectiveness ratio of the resources use (both from the view of the statutory health insurances and the national economy).

Relatives; assessments at 0 months / 6 months / 12 months / 18 months / 24 months:
- Reduction of the burden on relatives (IEQ ) and improvement of their satisfaction with care (ZUF8) as well as their quality of life (WHOQOL-BREF)

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

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Recruitment

  •   Planned
  •   2020/04/01
  •   1000
  •   Multicenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   no maximum age
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Additional Inclusion Criteria

- Presence of mental illness of ICD-10 diagnosis groups F2, F3, F4, F5 or F6)
- Membership of one of the participating health insurance companies
- Permanent residence in one of the twelve regions of care
- Indication for GBV established by screening assessment

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Exclusion Criteria

- Primary symptoms of ICD-10 diagnosis groups F0, F1, F7, F8 or F9
- Considerable need for somatic treatment or care
- Participation in a contract of "Netzwerk psychische Gesundheit" (NWpG, network mental health) or "Seelische Gesundheit leben (SeGel, Living Mental Health) in the last 6 months before the study starts
- Forensic psychiatric hospital
- Suspension of the entitlement to benefits according to § 16 SGB V

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Addresses

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    • Dachverband Gemeindepsychiatrie e. V.
    • Mr.  Nils  Greve 
    • Richartzstraße 12
    • 50667  Köln
    • Germany
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    • Klinik für Psychiatrie und Psychotherapie II der Universität Ulm am Bezirkskrankenhaus Günzburg, Sektion: Gesundheitsökonomie und Versorgungsforschung
    • Mr.  Prof.  Reinhold  Kilian 
    • Ludwig-Heilmeyer-Straße 2
    • 89312  Günzburg
    • Germany
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    • Dachverband Gemeindepsychiatrie e. V.
    • Mr.  Nils  Greve 
    • Richartzstraße 12
    • 50667  Köln
    • Germany
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Sources of Monetary or Material Support

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    • Innovationsausschuss beim gemeinsamen Bundesausschuss
    • 10587  Berlin
    • Germany
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Status

  •   Recruiting planned
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Trial Publications, Results and other Documents

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* This entry means the parameter is not applicable or has not been set.