Trial document




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  DRKS00005111

Trial Description

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Title

IVPOWER - effectiveness and efficiency of contracts in integrative care from patients suffering serious mental illnesses in real surroundings with particular attention to improvement of empowerment and quality of life

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Trial Acronym

IVPOWER

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URL of the Trial

[---]*

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Brief Summary in Lay Language

Currently, different models for improvement of psychiatric care are tested. The focus of these projects is the improvement of quality of life and of the ability for independent living (empowerment) of patients suffering serious mental illnesses. This study is meant to evaluate different concepts of psychiatric care. The results of this study will contribute to better understanding of need for ambulatory and stationary psychiatric care and will contribute to development of current care concepts. The study takes place in five regions in Germany (Berlin, Dresden, Kiel, Munich, Solingen). In the context of this study patients and their relatives will be interrogated four times within two years (every 6 months). The questionnaires include information to health state, quality of life and empowerment of patients. Moreover, data to the utilization of medical and psychotherapeutic offers will be collected.

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Brief Summary in Scientific Language

Focus of this project is the transregional analysis of effectiveness and cost-effectiveness of contracts for integrated care programs according to NWpG compared to treatment as usual in real surroundings in the following regions: Berlin, Dresden, Kiel, Munich and Solingen.
The main outcome criteria are the improvement of empowerment as well as improvement of patients’ subjective quality of life.
Moreover, the consequences of NWpG contracts for integrated care programs on burden and quality of life of relatives and persons of reference will be evaluated.

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Organizational Data

  •   DRKS00005111
  •   2013/07/26
  •   [---]*
  •   yes
  •   Approved
  •   129/13, Ethik-Kommission der Universität Ulm
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Secondary IDs

  • [---]*
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Health Condition or Problem studied

  •   F20-F29 -  Schizophrenia, schizotypal and delusional disorders
  •   F30-F39 -  Mood [affective] disorders
  •   F40-F48 -  Neurotic, stress-related and somatoform disorders
  •   F60-F69 -  Disorders of adult personality and behaviour
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Interventions/Observational Groups

  •   The integrated care-group consists of 250 patients (50 patients per region) with schizophrenic (F2 ICD-10), affective (F3 ICD-10) disorders or other serious mental illnesses, who enroll in the IV programme according to NWpG model within 6 months after start of study. The recruitment for the integrated care-group takes place during general registration to a program of integrated care according to the NWpG model.
    In the context of this study patients will be interrogated four times, every 6 months. The questionnaires include information to health state, quality of life and empowerment of patients. Moreover, data to the utilization of medical and psychotherapeutic offers will be collected.
  •   The control group consists of 250 patients (50 patients per region) with schizophrenic (F2 ICD-10), affective (F3 ICD-10) disorders or other serious mental illnesses, who meet the criteria for enrollment in the integrated care program according to the NWpG model, but who haven’t enrolled so far and who are not willing to enroll in an integrated care program during course of the study. The recruitment for the control group happens with aid of service providers for integrated care and of cooperating psychiatric health institutions.
    In the context of this study patients will be interrogated four times, every 6 months. The questionnaires include information to health state, quality of life and empowerment of patients. Moreover, data to the utilization of medical and psychotherapeutic offers will be collected.
  •   Relatives and close persons of reference of in arm 1 included patients (integrated care, target: 125 persons).
    In the context of this study relatives of patients will be interrogated four times, every 6 months. The questionnaires include information to the relationship to the patient, the relative's quality of life and his satisfaction as regards treatment and care.
  •   Relatives and close persons of reference of in arm 2 included patients (treated as usual, target: 125 persons).
    In the context of this study relatives of patients will be interrogated four times, every 6 months. The questionnaires include information to the relationship to the patient, the relative's quality of life and his satisfaction as regards treatment and care.
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Characteristics

  •   Non-interventional
  •   Observational study
  •   Non-randomized controlled trial
  •   Open (masking not used)
  •   [---]*
  •   Active control (effective treament of control group)
  •   Health care system
  •   Parallel
  •   N/A
  •   N/A
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Primary Outcome

EPAS: change in empowerment total score over 18 months; measuring points: 0 month / 6 months / 12 months / 18 months

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Secondary Outcome

Interrogation of patients: measuring points: 0 month / 6 months / 12 months / 18 months
Reduction in psychosocial and clinical impairment using HoNos
Improvement of subjective quality of life using WHO-QoL
Reduction of unmet needs for psychiatric and psychosocial services using CAN-EU
Increase in satisfaction with psychiatric treatment using ZuF8
Reduction of utilization of stationary and simultaneous increase in utilization of ambulatory medical and psychosocial services using CSSRI
Reduction of direct and indirect healthcare costs using CSSRI
Reduction of costs of recovering a “healthy” year of life (QALY) using EQ-5D ///
Interrogation of relatives and persons of reference: measuring points: 0 month / 6 months / 12 months / 18 months
Perception of burden related to support of patient suffering serious mental illness using IEQ
Subjective quality of life using WHO-QoL-BREF
Satisfaction with psychiatric treatment using ZuF8

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • other 
  • other 
  • other 
  • other 
  • other 
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Recruitment

  •   Actual
  •   2013/08/23
  •   750
  •   Multicenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   80   Years
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Additional Inclusion Criteria

The integrated care group consists of 250 patients (50 patients per region) with schizophrenic (F2 ICD-10), affective (F3 ICD-10) disorders or other serious mental illnesses, who enroll in a program for integrated care according to the NWpG model within 6 months after start of study. /// The control group consists of 250 patients (50 patients per region) with schizophrenic (F2 ICD-10), affective (F3 ICD-10) disorders or other serious mental illnesses, who meet the criteria for enrollment in the program for integrated care according to the NWpG model but who haven’t enrolled so far and who are not willing to enroll in an integrated care program according to the NWpG during course of the study. /// Relatives and close persons of reference of in study included patients, who are willing to take part at study.

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Exclusion Criteria

primary diagnosis of ICD-10 groups F0 – F1;
existence of a care level

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Addresses

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    • Universität Ulm Klinik für Psychiatrie und Psychotherapie II Sektion: Gesundheitsökonomie und Versorgungsforschung
    • Mr.  Prof. Dr. rer. soc.  Reinhold  Kilian 
    • Ludwig-Heilmeyer-Str. 2
    • 89312  Günzburg
    • Germany
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    • Universität Ulm Klinik für Psychiatrie und Psychotherapie II Sektion: Gesundheitsökonomie und Versorgungsforschung
    • Mr.  Prof. Dr. rer. soc.  Reinhold  Kilian 
    • Ludwig-Heilmeyer-Str. 2
    • 89312  Günzburg
    • Germany
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    • Universität Ulm Klinik für Psychiatrie und Psychotherapie II Sektion: Gesundheitsökonomie und Versorgungsforschung
    • Ms.  Dipl. Ern.-Wiss.  Annabel  Stierlin 
    • Ludwig-Heilmeyer-Str. 2
    • 89312  Günzburg
    • Germany
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Sources of Monetary or Material Support

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    • BMG / Projektträger im DLR
    • Heinrich-Konen-Straße 1
    • 53227  Bonn
    • Germany
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Status

  •   Recruiting complete, follow-up complete
  •   2016/02/04
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Trial Publications, Results and other Documents

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