Trial document





This trial has been registered retrospectively.
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  DRKS00007780

Trial Description

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Title

Patient-associated, gender and migration specific barriers of acceptance and follow-up characteristics within an integrative disease management programm for patients with heart failure

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Trial Acronym

GemaB

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URL of the Trial

[---]*

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Brief Summary in Lay Language

Disease management programms are shown to be effective but usually are not accepted by all patients who would be medically eligible. Besides structural reasons sociodemographic and psychological factors are expected to underly this lack of acceptance. However, so far the problem of lack of program participation is unclear. Hence, the evaluation of respective indicators is crucial to prevent future discrimination and implement instruments for the broad applicability. The aim of GemaB is to examine the effect of sociademographic and psychological factors with special focus on gender and ethnicity on the patient-associated acceptance for participation within an existing dsease management programm for patients with heart failure.

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Brief Summary in Scientific Language

Disease management programms are shown to be effective but usually are not accepted by all patients who would be medically eligible. Besides structural reasons sociodemographic and psychological factors are expected to underly this lack of acceptance. However, so far the problem of non-responders is unclear. Hence, the evaluation of respective indicators is crucial to prevent future discrimination and implement instruments for the broad applicability. The aim of GemaB is to examine the effect of sociademographic and psychological factors with special focus on gender and ethnicity on the patient-associated acceptance for participation within an existing dsease management programm for patients with heart failure.

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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

  •   DRKS00007780
  •   2015/02/09
  •   [---]*
  •   yes
  •   Approved
  •   13-041, Ethik-Kommission der Medizinischen Fakultät der Universität zu Köln
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Secondary IDs

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

  •   I50 -  Heart failure
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Interventions/Observational Groups

  •   Observation: Assessment of inclusion statistics, acceptance of the modell, satisfaction with the model, quality of treatment, clinical follow-up for Turkish patients in comparison to German patients
  •   Observation: Assessment of inclusion statistics, acceptance of the modell, satisfaction with the model, quality of treatment, clinical follow-up for German patients as controls
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Characteristics

  •   Non-interventional
  •   Observational study
  •   Non-randomized controlled trial
  •   Open (masking not used)
  •   [---]*
  •   Other
  •   Health care system
  •   Parallel
  •   N/A
  •   N/A
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Primary Outcome

acceptance for participation measured by inclusion statistics und questrionaires (baseline), satisfaction with the program assessed by questionaires (1year), total followup max 1.5 years

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Secondary Outcome

clinical follow-up for mortality, hospitalization, NYHA Class, treatment compliance, quality of life (brief PHQ questionaire), depression (Dole scale, visual analog scale), assessed every 3 months, max followup 1.5 years

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • Medical Center 
  • Doctor's Practice 
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Recruitment

  •   Actual
  •   2013/07/04
  •   700
  •   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

heart failure

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Exclusion Criteria

Care outside of Cologne

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Addresses

  • start of 1:1-Block address primary-sponsor
    • Med. Klinik III, Herzzentrum
    • Mr.  Prof. Dr.  H.-W.  Höpp 
    • Kerpener Str. 62
    • 50937  Köln
    • Germany
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    • Med. Klinik III, Herzzenturm
    • Mr.  PD Dr.  R.  Pfister 
    • Kerpener Str. 62
    • 50937  Köln
    • Germany
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    • Med. Klinik III, Herzzentrum
    • Ms.  Petra  Daniels 
    • Kerpenerstr. 62
    • 50937  Köln
    • Germany
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Sources of Monetary or Material Support

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    • Projektträger ETNForschungszentrum Jülich
    • Karl-Heinz-Beckurts-str. 13
    • 52428  Jülich
    • Germany
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    •   00492461690
    •   [---]*
    •   [---]*
    •   [---]*
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Status

  •   Recruiting complete, follow-up complete
  •   2015/06/01
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Trial Publications, Results and other Documents

  •   Ergebnisbericht beim Sponsor anforderbar
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* This entry means the parameter is not applicable or has not been set.