ISRCTN ISRCTN16755335
DOI https://doi.org/10.1186/ISRCTN16755335
Secondary identifying numbers 1.0
Submission date
06/07/2019
Registration date
14/07/2019
Last edited
24/02/2020
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Urological and Genital Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year

Plain English summary of protocol

Background and study aims
The aim of NEPHRO-DIGITAL is to create a regional eHealth platform in the Hannover region that facilitates integrated, cross-sectoral data exchange and includes teleconsultation between outpatient nephrology, primary care, pediatricians and nephrology clinics to reduce communication deficits and prevent data loss, and to enable the creation and implementation of an interoperable clinical decision support system.

Who can participate?
All pediatric and adult nephrologic patients of the region of Hannover can use the eHealth platform.

What does the study involve?
This system is based on input data from multiple sources for early identification of patients with cardiovascular comorbidity and progression of renal insufficiency. Especially patients will be able to enter and access their own data. A decision support system should lead to earlier therapeutic interventions and thereby improve the prognosis of patients as well as their treatment satisfaction and quality of life. The system will be integrated in the two largest German health platforms in university medicine HIGHMed and MIRACUM.

What are the possible benefits and risks of participating?
The possible benefit would be more integration of patient data. There is no risk.

Where is the study run from?
The study is run from Hannover Medical School.

When is the study starting and how long is it expected to run for?
The study will take place from January 2020 till December 2022.

Who is funding the study?
The study is funded by the Ministry of Research and Culture of Lower Saxoney and the Volkswagen Foundation (Niedersachsen Vorab).

Who is the main contact?
The main contact is Prof. Dr. med. Lars Pape: Pape.Lars@mh.hannover.de

Contact information

Prof Lars Pape
Scientific

MHH, Carl-Neuberg-Straße 1
Hannover
D-30625
Denmark

Phone +495115323283
Email Pape.Lars@mh-hannover.de

Study information

Study designQualitative interviews
Primary study designOther
Secondary study design
Study setting(s)Internet/virtual
Study typeOther
Participant information sheet No participant information sheet available.
Scientific titleThe nephrology eHealth-System of the metropolitan region of Hannover for digitalization of care, establishment of decision support systems and analysis of health care quality
Study acronymNephroDIGITAL
Study objectivesThe primary hypothesis underlying the project is that the digitization of nephrology data presented above will result in a significant improvement in patient care and, in addition, will lead to cost savings in the health care system by reducing hospitalization and redundant diagnostics (hospital, nephrologist, general practitioner/pediatrician) and treatment and by improving quality of life.
Ethics approval(s)Ethics approval is not required: The NephroDigital Project has been submitted to the ethics committee of Hannover Medical School. The committee has confirmed that the study can be carried out without a formal ethics vote as the main aim of the study is to develop new IT interfaces.
Health condition(s) or problem(s) studiedNephrologic diseases
InterventionPatients and Health care professional will be able to use eHealth system.

The trial has no formal patient inclusion. During the trial, patients will experience an improved IT-environment. Patients will be followed up as long as they use the new IT.
Intervention typeDevice
Pharmaceutical study type(s)
PhaseNot Applicable
Drug / device / biological / vaccine name(s)N/A
Primary outcome measureImplementation of a cross-sector electronic case file eFA including teleconsultations and patient access. Indicator: 50% of patients with shared use of eFA after 30 months.
Secondary outcome measures1. Evaluation of care provider needs on data and information sharing, acceptance and feasibility (qualitatively, interviews with GPs / pediatricians) at 30 months.
2. Implementation of a decision support system for GFR deterioration and cardiovascular comorbidities. Indicator: System is implemented at 30 months
3. Comparison of intersectoral treatment quality between Hannover Region and Erlangen. Indicator: Analysis performed at 30 months
4. Reduction of complications of nephrological diseases. Indicator: Reduction of complications requiring inpatient treatment. Indicator: A 10% reduction of hospital expenditure within 30 months compared to a control cohort (historical control patients who did not participate in the program)
5. Reduction in cardiovascular events. Indicator: The number of hospitalizations due to cardiovascular events will be reduced > 10% within 30 months.
6. After the establishment of NEPHRO-DIGITAL, participant quality of life will improve significantly. Indicator: In the mental subscale of the SF-12, 80% of the participating patients will reach values which do not differ from population norm data within 30 months.
7. Is the use of the new digital elements and the quality of life gender-dependent? Does a migration background play a role in the acceptance of digital medicine? Indicator: Participation rate in subgroups is not significantly different after 30 months.
Overall study start date01/01/2020
Completion date12/12/2022

Eligibility

Participant type(s)All
Age groupAll
SexBoth
Target number of participantsThere will by around 300 pediatric and 5000 adult nephrologic patients
Key inclusion criteriaAll pediatric and adult nephrologic patients in the Region Hannover will be indirectly part of the trial by improving the IT-architecture.
Key exclusion criteriaN/A
Date of first enrolment01/01/2021
Date of final enrolment30/09/2022

Locations

Countries of recruitment

  • Germany

Study participating centre

Hannover Medical School
Carl-Neuberg-Straße 1
Hannover
D-30625
Germany

Sponsor information

Hannover Medical School
University/education

Carl-Neuberg-Straße 1
Hannover
D-30625
Germany

Phone +405115320
Email Pape.Lars@mh-hannover.de
Website http://www.mh-hannover.de
ROR logo "ROR" https://ror.org/00f2yqf98

Funders

Funder type

Government

Volkswagen Stiftung, Ministry of Science and Culture of Lower Saxony

No information available

Results and Publications

Intention to publish date31/12/2019
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryData sharing statement to be made available at a later date
Publication and dissemination planPlanned publication in a high-impact peer-reviewed journal.
IPD sharing planThe data sharing plans for the current study are unknown and will be made available at a later date.

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Protocol article protocol 02/09/2019 Yes No

Editorial Notes

24/02/2020: Publication reference added.
09/07/2019: Trial's existence confirmed by the Ministry of Research and Culture of Lower Saxony.