Telemedically supported aftercare after living donor renal transplantation
Organizational Data
- DRKS-ID:
- DRKS00007634
- Recruitment Status:
- Recruiting complete, study complete
- Date of registration in DRKS:
- 2015-01-28
- Last update in DRKS:
- 2023-08-07
- Registration type:
- Retrospective
Acronym/abbreviation of the study
No Entry
URL of the study
http://www.transplantationszentrum-freiburg.de
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.
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.
Health condition or problem studied
- ICD10:
- N17-N19 - Renal failure
- ICD10:
- Z94.0 - Kidney transplant status
- Healthy volunteers:
- No Entry
Interventions, Observational Groups
- Arm 1:
- 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.
- Arm 2:
- 23 patients (standard of care group) with routine evidence-based aftercare in the first year after renal transplantation
Endpoints
- Primary outcome:
- Unplanned inpatient hospitalization (unplanned admission rate) at 3,6, 12 months after transplantation
- 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
Study Design
- Purpose:
- Supportive care
- Allocation:
- Randomized controlled study
- Control:
-
- Active control (effective treatment of control group)
- Phase:
- N/A
- Study type:
- Interventional
- Mechanism of allocation concealment:
- No Entry
- Blinding:
- No
- Assignment:
- Parallel
- Sequence generation:
- No Entry
- Who is blinded:
- No Entry
Recruitment
- Recruitment Status:
- Recruiting complete, study complete
- Reason if recruiting stopped or withdrawn:
- No Entry
Recruitment Locations
- Recruitment countries:
-
- Germany
- Number of study centers:
- Monocenter study
- Recruitment location(s):
-
- University medical center Department Chirurgie, Klinik für Allgemein- und Visczeralchirurgie, Transplantationszentrum Freiburg im Breisgau
Recruitment period and number of participants
- Planned study start date:
- No Entry
- Actual study start date:
- 2011-10-28
- Planned study completion date:
- No Entry
- Actual Study Completion Date:
- 2014-04-30
- Target Sample Size:
- 50
- Final Sample Size:
- 46
Inclusion Criteria
- Sex:
- All
- Minimum Age:
- 18 Years
- Maximum Age:
- no maximum age
- 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.
Exclusion Criteria
Age < 18. Challenged in taking medication independently. No literate German speaker. No consensus in randomized allocation and anonymized data processing.
Addresses
Primary Sponsor
- Address:
- Universitätsklinikum Freiburg, Department Chirurgie, Klinik für Allgemein- und Viszeralchirurgie,Prof. Dr. Dr. h.c. Ulrich-Theodor HoptHugstetter Strasse 5579106 FreiburgGermany
- Telephone:
- +49 761 270 28060
- Fax:
- +49 761 270 28040
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- http://www.uniklinik-freiburg.de
- Investigator Sponsored/Initiated Trial (IST/IIT):
- Yes
Contact for Scientific Queries
- Address:
- Universitätsklinikum Freiburg, Department Chirurgie,Klinik für Allgemein- und Viszeralchirurgie,TransplantationszentrumPD Dr. Przemyslaw PisarskiHugstetter Strasse 5579106 FreiburgGermany
- Telephone:
- +49 761 270 28590
- Fax:
- +49 761 278970
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- http://www.transplantationszentrum-freiburg.de
Contact for Public Queries
- Address:
- Universitätsklinikum Freiburg, Department Chirurgie,Klinik für Allgemein- und Viszeralchirurgie,TransplantationszentrumDipl.-Psychol. Anja SchmidHugstetter Strasse 5579106 FreiburgGermany
- Telephone:
- +49 761 270 27320
- Fax:
- +49 761 278970
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- http://www.transplantationszentrum-freiburg.de
Principal Investigator
- Address:
- Universitätsklinikum Freiburg, Department Chirurgie,Klinik für Allgemein- und Viszeralchirurgie,TransplantationszentrumPD Dr. Przemyslaw PisarskiHugstetter Strasse 5579106 FreiburgGermany
- Telephone:
- +49 761 270 28590
- Fax:
- +49 761 278970
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- http://www.transplantationszentrum-freiburg.de
Sources of Monetary or Material Support
Commercial (pharmaceutical industry, medical engineering industry, etc.)
- Address:
- Abteilung Transplantation & ImmunologieRoonstraße 2590429 NürnbergGermany
- Telephone:
- No Entry
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- No Entry
Public funding institutions financed by tax money/Government funding body (German Research Foundation (DFG), Federal Ministry of Education and Research (BMBF), etc.)
- Address:
- INTERREG IV Rhin Supérieur / OberrheinRégion Alsace – DREI1 place Adrien Zeller – BP 91006F 67070 STRASBOURGFrance
- Telephone:
- No Entry
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- http://www.interreg-oberrhein.eu/projet/prometheus-die-nikt-im-dienste-der-betreuung-von-transplantationspatienten/?cat=189-190
Institutional budget, no external funding (budget of sponsor/PI)
- Address:
- Universitätsklinikum Freiburg, Department Chirurgie,Klinik für Allgemein- und Viszeralchirurgie,TransplantationszentrumHugstetter Strasse 5579106 FreiburgGermany
- Telephone:
- No Entry
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- http://www.transplantationszentrum-freiburg.de
Ethics Committee
Address Ethics Committee
- Address:
- Ethik-Kommission der Albert-Ludwigs-Universität FreiburgEngelberger Str. 2179106 FreiburgGermany
- Telephone:
- +49-761-27072600
- Fax:
- +49-761-27072630
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- No Entry
Vote of leading Ethics Committee
- Vote of leading Ethics Committee
- Date of ethics committee application:
- 2014-12-18
- Ethics committee number:
- 608/14
- Vote of the Ethics Committee:
- Approved
- Date of the vote:
- 2015-01-19
Further identification numbers
- Other primary registry ID:
- No Entry
- EudraCT Number:
- No Entry
IPD - Individual Participant Data
- Do you plan to make participant-related data (IPD) available to other researchers in an anonymized form?:
- No
- IPD Sharing Plan:
- No Entry
Study protocol and other study documents
- Study protocols:
- No Entry
- Study abstract:
- No Entry
- Other study documents:
- No Entry
- Background literature:
- No Entry
- Related DRKS studies:
- No Entry
Publication of study results
- Planned publication:
- No Entry
- Publikationen/Studienergebnisse:
- Schmid A, Hils S, Kramer-Zucker A, Bogatyreva L, Hauschke D, De Geest S & Pisarski P. Telemedically Supported Case Management of Living-Donor Renal Transplant Recipients to Optimize Routine Evidence-Based Aftercare: A Single-Center Randomized Controlled Trial. Am J Transplant 2017; 17(6): 1594–1605. doi: 10.1111/ajt.14138. Epub 2017 Jan 5.
- Date of first publication of study results:
- No Entry
- DRKS entry published for the first time with results:
- No Entry
Basic reporting
- Basic Reporting / Results tables:
- No Entry
- Brief summary of results:
- No Entry