Trial document



drksid header

  DRKS00004283

Trial Description

start of 1:1-Block title

Title

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

end of 1:1-Block title
start of 1:1-Block acronym

Trial Acronym

GeKiM

end of 1:1-Block acronym
start of 1:1-Block url

URL of the Trial

[---]*

end of 1:1-Block url
start of 1:1-Block public summary

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).

end of 1:1-Block public summary
start of 1:1-Block scientific synopsis

Brief Summary in Scientific Language

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

end of 1:1-Block scientific synopsis
start of 1:1-Block forwarded Data

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

[---]*

end of 1:1-Block forwarded Data
start of 1:1-Block forwarded Data Content

Description IPD sharing plan:

[---]*

end of 1:1-Block forwarded Data Content
start of 1:1-Block organizational data

Organizational Data

  •   DRKS00004283
  •   2012/09/06
  •   [---]*
  •   yes
  •   Approved
  •   294/12 und 294/12_140826 (Amendment), Ethik-Kommission der Albert-Ludwigs-Universität Freiburg
end of 1:1-Block organizational data
start of 1:n-Block secondary IDs

Secondary IDs

  • [---]*
end of 1:n-Block secondary IDs
start of 1:N-Block indications

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.
  •   [---]* -  [---]*
end of 1:N-Block indications
start of 1:N-Block interventions

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.
end of 1:N-Block interventions
start of 1:1-Block design

Characteristics

  •   Non-interventional
  •   Observational study
  •   Single arm study
  •   Open (masking not used)
  •   [---]*
  •   Uncontrolled/Single arm
  •   Health care system
  •   Single (group)
  •   N/A
  •   [---]*
end of 1:1-Block design
start of 1:1-Block primary endpoint

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).

end of 1:1-Block primary endpoint
start of 1:1-Block secondary endpoint

Secondary Outcome

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

end of 1:1-Block secondary endpoint
start of 1:n-Block recruitment countries

Countries of Recruitment

  •   Germany
end of 1:n-Block recruitment countries
start of 1:n-Block recruitment locations

Locations of Recruitment

  • [---]*
end of 1:n-Block recruitment locations
start of 1:1-Block recruitment

Recruitment

  •   Actual
  •   2012/10/01
  •   900
  •   Monocenter trial
  •   National
end of 1:1-Block recruitment
start of 1:1-Block inclusion criteria

Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   no maximum age
end of 1:1-Block inclusion criteria
start of 1:1-Block inclusion criteria add

Additional Inclusion Criteria

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

end of 1:1-Block inclusion criteria add
start of 1:1-Block exclusion criteria

Exclusion Criteria

younger than 18years; not registered in the care model

end of 1:1-Block exclusion criteria
start of 1:n-Block addresses

Addresses

end of 1:n-Block addresses
start of 1:n-Block material support

Sources of Monetary or Material Support

  • start of 1:1-Block address materialSupport
    • Universität Freiburg, Medizinische Fakultät, Abteilung Medizinische Psychologie und Medizinische Soziologie
    • Mr.  Dr.  Ulrich  Stößel 
    • Hebelstr. 29
    • 79104  Freiburg
    • Germany
    end of 1:1-Block address materialSupport
    start of 1:1-Block address contact materialSupport
    end of 1:1-Block address contact materialSupport
  • start of 1:1-Block address otherSupport
    • Gesundes Kinzigtal GmbH
    • Ms.  Dr.  Monika  Roth 
    • Strickerweg 3d
    • 77716  Haslach
    • Germany
    end of 1:1-Block address otherSupport
    start of 1:1-Block address contact otherSupport
    end of 1:1-Block address contact otherSupport
end of 1:n-Block material support
start of 1:1-Block state

Status

  •   Recruiting ongoing
  •   [---]*
end of 1:1-Block state
start of 1:n-Block publications

Trial Publications, Results and other Documents

  • [---]*
end of 1:n-Block publications
* This entry means the parameter is not applicable or has not been set.