Trial document





This trial has been registered retrospectively.
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  DRKS00009233

Trial Description

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Title

Telemedical supported aftercare in the first post-operative year for transplanted patients after living-donor kidney donation, postmortal kidney donation and combined pancreas-/kidney donation.

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Trial Acronym

[---]*

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URL of the Trial

http://www.transplantationszentrum-freiburg.de/telemedizin.html

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Brief Summary in Lay Language

The project study examines theeffects of telemedically supported aftercare (telemedically supported case management) compared to the standard of aftercare for renal transplant patients after living-donor donation, after postmortal kidney donation and combined pancreas-/kidney donation in terms of the number and length of stay of unplanned hospitalization and the transplant function.

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Brief Summary in Scientific Language

A prospective, randomized, controlled and open study was initiated. 24 patients with standard of care (as control group),
24 patients with standard of care and additional telemedically supported aftercare (case management). Telemedical aspectes: Touchscreen-Device with videocamera and microfone at home.
Via an interactive web-based telemonitor, the telemedically supported aftercare group enters at home daily data about their physical condition into a defined medical questionnaire. These data are checked daily by medical staff of the Transplantation Center Freiburg. In case of noticeable entries a case management team memeber contacts the patient by mobile phone or video-conference to offer healthcare-related decision support and/ or timely linking to direct medical services.
For the complete repeated measure analysis, both groups are examined at four time points (0, 3, 6 and 12 months after transplantation) in regard to number and length of stay of unplanned hospitalization and transplant function.
Observation period: July 2013 to the expected End of 2018.

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Organizational Data

  •   DRKS00009233
  •   2015/08/26
  •   [---]*
  •   yes
  •   Approved
  •   258/15, Ethik-Kommission der Albert-Ludwigs-Universität Freiburg
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Secondary IDs

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

  •   N17-N19 -  Renal failure
  •   Z94.0 -  Kidney transplant status
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Interventions/Observational Groups

  •   24 patients (Interventiongroup) with telemedical supported aftercare (case management) in the first year after renal transplantation additionally to standard of care.
    Daily data-entry in a defined questionnaire via remote monitoring.
    Remote monitoring helps to support a patient in real-time interaction in case of critical entries
    and when feeling insecure with daily life management.
  •   24 patients (standard of care group) with routine evidence-based aftercare in the first year after renal transplantation
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Characteristics

  •   Interventional
  •   [---]*
  •   Randomized controlled trial
  •   Open (masking not used)
  •   [---]*
  •   Active control (effective treament of control group)
  •   Supportive care
  •   Parallel
  •   N/A
  •   N/A
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Primary Outcome

Unplanned inpatient hospitalization (unplanned admission rate) at 3,6, 12 months after transplantation

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Secondary Outcome

Length of stay of unplanned hospitalizations at 3,6,12 months after transplantation.
Graft function (eGFR calculated by CKD-EPI-Formula), measured on the basis of internal and external medical reports during the first postoperative year at 0,3,6 and 12 months after transplantation.

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
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Recruitment

  •   Actual
  •   2013/07/15
  •   48
  •   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

Kidney transplantation in Tx Center Freiburg after living-donation, postmortal kidney donation or combined pancreas-/kidney transplantation.
Inclusion directly before discharge for hospital
Age >18
Good self-management in taking medication
German language
Consensus with randomization
written consent in randomization and in anonymized data processing

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Exclusion Criteria

Age < 18
bad self-management in taking medication
no german language
no consensus in randomization
no written consent in anonymized data processing

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Addresses

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    • Universitätsklinikum Freiburg, Department Chirurgie, Klinik für Allgemein- und Viszeralchirurgie,
    • Mr.  Prof. Dr. Dr. h.c.  Ulrich-Theodor  Hopt 
    • Hugstetter Strasse 55
    • 79106  Freiburg
    • Germany
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    • Universitätsklinikum Freiburg, Department Chirurgie,Klinik für Allgemein- und Viszeralchirurgie,Transplantationszentrum
    • Mr.  PD Dr.  Przemyslaw  Pisarski 
    • Hugstetter Strasse 55
    • 79106  Freiburg
    • Germany
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    • Universitätsklinikum Freiburg, Department Chirurgie,Klinik für Allgemein- und Viszeralchirurgie,Transplantationszentrum
    • Ms.  Dipl.-Psychol.  Anja  Schmid 
    • Hugstetter Strasse 55
    • 79106  Freiburg
    • Germany
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Sources of Monetary or Material Support

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    • Universitätsklinikum Freiburg, Department Chirurgie,Klinik für Allgemein- und Viszeralchirurgie,Transplantationszentrum
    • Hugstetter Strasse 55
    • 79106  Freiburg
    • Germany
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Status

  •   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.