Trial document





This trial has been registered retrospectively.
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  DRKS00007634

Trial Description

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Title

Telemedically supported aftercare after living donor renal transplantation

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Trial Acronym

[---]*

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URL of the Trial

http://www.transplantationszentrum-freiburg.de

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Brief Summary in Lay Language

The project study examines the effects of telemedically supported aftercare (telemedically supported case management) compared to the standard of aftercare for living donor renal transplant recipients. Expected outcomes are differences in number and length of stay of unplanned inpatient hospitalization, transplant function, adherence in regard to taking immunosuppressive drugs, health-related and disease-specific quality of life and the return to employment.

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Brief Summary in Scientific Language

A prospective, randomized, controlled and open project study with 46 living donor renal transplant recipients was initiated.
• 23 patients with standard of care (as control group)
• 23 patients with standard of care and telemedically supported aftercare (case management).
Telemedical aspects: Touchscreen-Device with videocamera and microfone at home.

Via an interactive web-based telemonitor, the telemedically supported aftercare group entered at home daily data about their physical condition into a defined medical questionnaire. These data were checked daily by medical staff of the Transplantation Center Freiburg. In case of noticeable entries a case management team member contacts the patient by mobile phone or video-conference to offer health-care related decision support and/or timely linking to direct medical services. Observation period: October 2011 to April 2014. Both groups have been examined at four time points (0, 3, 6 and 12 months after transplantation) via medical reports and standardized Interviews/Questionnaires (BAASIS®, ESRD-SCL®, BSI-18®, ALL) about the course of their medical condition (number and length of inpatient hospitalizations and the corresponding diagnoses, transplant function), their adherence concerning the intake of immunosuppressive medication, health-related and disease-specific quality of life and working time percentages.

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Organizational Data

  •   DRKS00007634
  •   2015/01/28
  •   [---]*
  •   yes
  •   Approved
  •   608/14, 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

  •   23 patients (Interventiongroup) with telemedically 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 and real-time video-conferences as a support for the patients in case of critical entries
    and when they are feeling insecure with daily life management.
  •   23 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

Unplanned prolonged inpatient hospitalization (length of unplanned stay),
Rate of acute rejection,
Sum of days until acute rejection therapy initiation,
Maintenance of transplant function,
Ambulatory care visits,
Immunosuppressive regime adherence,
Quality of life,
Return to employment

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
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Recruitment

  •   Actual
  •   2011/10/28
  •   50
  •   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.
Inclusion directly before discharge from hospital.
Age >18.
Ability to take medication independently.
Literate German speaker.
Consensus with randomization.
Written consent in randomizad allocation and in anonymized data processing.

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Exclusion Criteria

Age < 18.
Challenged in taking medication independently.
No literate German speaker.
No consensus in randomized allocation and 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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    • Abteilung Transplantation & Immunologie
    • Novartis Pharma GmbH 
    • Roonstraße 25
    • 90429  Nürnberg
    • Germany
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    •   [---]*
    •   [---]*
    •   [---]*
    •   [---]*
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    • INTERREG IV Rhin Supérieur / OberrheinRégion Alsace – DREI
    • 1 place Adrien Zeller – BP 91006
    • F 67070  STRASBOURG
    • France
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Status

  •   Recruiting complete, follow-up complete
  •   2014/04/30
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* This entry means the parameter is not applicable or has not been set.