Plain English Summary
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
Trial website
Contact information
Type
Scientific
Primary contact
Prof Lars Pape
ORCID ID
Contact details
MHH
Carl-Neuberg-Straße 1
Hannover
D-30625
Denmark
+495115323283
Pape.Lars@mh-hannover.de
Additional identifiers
EudraCT number
Nil known
ClinicalTrials.gov number
Nil known
Protocol/serial number
1.0
Study information
Scientific title
The nephrology eHealth-System of the metropolitan region of Hannover for digitalization of care, establishment of decision support systems and analysis of health care quality
Acronym
NephroDIGITAL
Study hypothesis
The 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
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.
Study design
Qualitative interviews
Primary study design
Other
Secondary study design
Trial setting
Internet
Trial type
Other
Patient information sheet
No participant information sheet available.
Condition
Nephrologic diseases
Intervention
Patients 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 type
Device
Phase
Not Applicable
Drug names
N/A
Primary outcome measure
Implementation 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 measures
1. 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 trial start date
01/01/2020
Overall trial end date
12/12/2022
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
All pediatric and adult nephrologic patients in the Region Hannover will be indirectly part of the trial by improving the IT-architecture.
Participant type
All
Age group
All
Gender
Both
Target number of participants
There will by around 300 pediatric and 5000 adult nephrologic patients
Participant exclusion criteria
N/A
Recruitment start date
01/01/2021
Recruitment end date
30/09/2022
Locations
Countries of recruitment
Germany
Trial participating centre
Hannover Medical School
Carl-Neuberg-Straße 1
Hannover
D-30625
Germany
Sponsor information
Organisation
Hannover Medical School
Sponsor details
Carl-Neuberg-Straße 1
Hannover
D-30625
Germany
+405115320
Pape.Lars@mh-hannover.de
Sponsor type
University/education
Website
Funders
Funder type
Government
Funder name
Volkswagen Stiftung, Ministry of Science and Culture of Lower Saxony
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Planned publication in a high-impact peer-reviewed journal.
IPD sharing statement: the data sharing plans for the current study are unknown and will be made available at a later date.
Intention to publish date
31/12/2019
Participant level data
To be made available at a later date
Basic results (scientific)
Publication list
2019 protocol in https://www.ncbi.nlm.nih.gov/pubmed/31477119