Trial document





This trial has been registered retrospectively.
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  DRKS00011504

Trial Description

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Title

Telemedically-supported aftercare (case management) of living-donor renal transplant recipients. Follow-up study: Longterm outcomes after 5 years.

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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 completed project study (DRKS00007634) there were relevant medical and economic outcomes 1 year post transplant after living-donor renal transplantation. Therefore, the follow-up study evaluates at the timepoint 5 years post transplant, if the benefits in the intervention group are sustained long-term. This follow-up study seeks answers to the question: Has telemedically supported aftercare (telemedically supported case management) applied during the first year post transplant longterm outcomes at 5 years post transplant?“

Primary outcome is the number of unplanned inpatient hospitalization in the 1.-5. years post transplant. Secondary outcomes are the length of stay of unplanned inpatient hospitalization in days during the 1.-5. year post transplant, and also at timepoint 5 years post transplant the transplant function, immunosuppressive regime adherence, quality of life, and serious cardiovascular risk factors.

The selected patient collective for evaluation is the patient collective of the project study (DRKS00007634). The study intruments (questionnaires) are methodically the same as in the project study (DRKS00007634) and include the BAASIS, BSI-18, ALL, and ESRD-SCL(TM).

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Brief Summary in Scientific Language

In the project study (DRKS00007634) a randomized, controlled trial was performed with a patient collective of 46 patients after living-donor renal transplantation. The selected patient collective for evaluation is the patient collective of the project study. Their telemedically supported aftercare (case management) was completed at timepoint 1 year post transplant. At the timepoint 5 years post transplant, medical data from reports and questionnaires are used for the evaluation of the number and length of stay in days of unplanned inpatient hospitalization during the first 5 years post transplant. For the estimation of the transplant function, the estimated GFR using the CKD-EPI-equitation is calculated. For the immunosuppression regime adherence, the Tacrolimus trough level, collateral reports and self report via the BAASIS are used. Quality of life is measured with BSI-18, ALL and ESRD-SCL(TM). All study intruments (questionnaires) are methodically the same as in the project study (DRKS00007634). For the number of serious cardiovascular risk factors, the medical diagnoses of status post stroke, status post myocardial infarction, diabetes mellitus and the etsimated GFR (calculated by the CKD-EPI-equitation) are documented according the current medical reports. The observation period is October 2016 until April 2018. Both, the intervention group and the control group from the project study will be compared at timepoint 5 years post transplant.

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Organizational Data

  •   DRKS00011504
  •   2016/12/29
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  •   yes
  •   Approved
  •   410/16, Ethik-Kommission der Albert-Ludwigs-Universität Freiburg
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Secondary IDs

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Health Condition or Problem studied

  •   N17 -  Acute renal failure
  •   Z94.0 -  Kidney transplant status
  •   N18 -  Chronic kidney disease
  •   N19 -  Unspecified kidney failure
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Interventions/Observational Groups

  •   23 patients (interventiongroup) who received telemedically supported aftercare (case management) in the first year after renal transplantation additionally to standard of care, now being at timepoint 5 years post transplant. The telemedically supported aftercare was completed at timepoint 1 year post transplant. The patient collective is the same as in the project study (DRKS00007634)
  •   23 patients (standard of care group) with routine evidence based aftercare after renal transplantation, now being at timepoint 5 years post transplant. The patient collective is the same as in the project study (DRKS00007634).
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Characteristics

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

Number of unplanned inpatient hospitalization during the first 5 years post transplant, according to medical reports

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Secondary Outcome

Length of stay of unplanned inpatient hospitalization during the first 5 years post transplant, according to medical reports,
At timepoint 5 years post transplant: Transplant function (eGFR calculated by CKD-EPI-equitation), immunosuppressive regime adherence (Tacrolimus trough level, collateral reports, BAASIS), Quality of life (BSI-18, ALL, ESRD-SCL(TM)),
Number of serious cardiovaskular risk factors (status post stroke, status post myocardial infarciation, diabetes mellitus, eGFR calculated with CKD-EPI-equitation) during the first 5 years post transplant, according to medical reports

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
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Recruitment

  •   Actual
  •   2016/10/03
  •   46
  •   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

Patient participated in the project study (DRKS00007634)

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Exclusion Criteria

Patient did not participate in the project study (DRKS00007634)

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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 Str.55
    • 79106  Freiburg i. Br.
    • Germany
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    • Universitätsklinikum Freiburg, Department Chirurgie, Klinik für Allgemein- und Viszeralchirurgie, Transplantationszentrum
    • Mr.  PD Dr. med  Przemyslaw  Pisarski 
    • Hugstetter Str.55
    • 79106  Freiburg i. Br.
    • Germany
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    • Universitätsklinikum Freiburg, Department Chirurgie, Klinik für Allgemein- und Viszeralchirurgie, Transplantationszentrum
    • Ms.  Dipl.-Psychologin  Anja  Schmid 
    • Hugstetter Str.55
    • 79106  Freiburg i.Br.
    • 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.