Trial document

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Trial Description

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Questionnaire Survey on Insurants’ Satisfaction with ’Gesundes Kinzigtal Integrated Care’

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Trial Acronym


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URL of the Trial


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Brief Summary in Lay Language

In the Kinzigtal region – a region surrounding the valley of the river Kinzig in Southwest Germany – an integrated health care project has started in late 2005, attempting to overcome the traditionally fragmented German health care system within this region.
In general, the goal of integrated care systems is to improve the cooperation of health care providers within and between different health care sectors.
This study gathers data, by means of a standardized questionnaire (sent by normal mail), first of all on enrolled patients' satisfaction with (a) their respective doctor of confidence, and (b) with the integrated care system as a whole. For this sake a random sample of enrolled insurants is surveyed.
An amendment of the study was proposed to the ethics committee of the University of Freiburg on August 26, 2014. Accordingly, the study will be amended with respect to two aspects: (1) The study will be continued as a trend study, with the first follow-up taking place two years after the baseline survey. (2) The standardized questionnaire will additionally contain the following instrument in all follow-up surveys: PAM-13-D (German version of the "Patient Activation Measure"). The proposed amendment was considered sound in ethical respects (294/12_140826; letter by the ethics committee as of September 03, 2014). (3) The follow-up survey will be sponsored by Gesundes Kinzigtal GmbH (address cf. below).

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Brief Summary in Scientific Language

Standardized written questionnaire study in a sample of members of the 'Gesundes Kinzigtal Integrated Care' (GKIC)

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


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Description IPD sharing plan:


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Organizational Data

  •   DRKS00004283
  •   2012/09/06
  •   [---]*
  •   yes
  •   Approved
  •   294/12 und 294/12_140826 (Amendment), Ethik-Kommission der Albert-Ludwigs-Universität Freiburg
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Secondary IDs

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Health Condition or Problem studied

  •   Primary target variables are items describing patients' satisfaction (a) with their respective doctors of confidence and (b) with the integrated care system as a whole. Furthermore, patients rate their individual health by a common Likert scale and with the aid of the EQ-5D questionnaire.
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Interventions/Observational Groups

  •   Observational study: a random sample of patients who have enrolled into 'Gesundes Kinzigtal Integrated Care' is surveyed every second year with the aid of standardized questionnaire.
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  •   Non-interventional
  •   Observational study
  •   Single arm study
  •   Open (masking not used)
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  •   Uncontrolled/Single arm
  •   Health care system
  •   Single (group)
  •   N/A
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Primary Outcome

Primary outcomes are surveyed every two years: willingness to recommend IVGK to friends or relatives, willingness to re-entry in to IVGK (both 4-point Likert scales), health-related support in the IVGK system (5-point Likert scale), change of one's own health behaviour (3-point Likert scale), growth of one's own health-related knowledge (3-point Likert scale), satisfaction with one's doctor of confidence (Weisse-Liste-Ärzte questionnaire), patient activation (PAM-13-D).

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Secondary Outcome

Every two years: Health-related quality of life (EQ-5D).

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

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  •   Actual
  •   2012/10/01
  •   900
  •   Monocenter trial
  •   National
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Inclusion Criteria

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

at least 18 years in age; registered member of the care model 'Integrierte Versorgung Gesundes Kinzigtal'

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Exclusion Criteria

younger than 18years; not registered in the care model

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Sources of Monetary or Material Support

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    • Universität Freiburg, Medizinische Fakultät, Abteilung Medizinische Psychologie und Medizinische Soziologie
    • Mr.  Dr.  Ulrich  Stößel 
    • Hebelstr. 29
    • 79104  Freiburg
    • Germany
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    • Gesundes Kinzigtal GmbH
    • Ms.  Dr.  Monika  Roth 
    • Strickerweg 3d
    • 77716  Haslach
    • Germany
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  •   Recruiting ongoing
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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.