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Background: In the face of extensive waiting times for outpatient psychotherapy, prescriptible digital health applications (DiGA) are a useful and effective addition to the range of available therapy options for patients with mild to moderate depression. However, older adults face a particular challenge in implementing DiGA since higher age is a decisive predictor of lower digital health literacy. The necessity of an independent use of the prescribed DiGA is therefore associated with challenges for older patients and providers. In practice, it is crucial not to leave patients, especially older adults, alone after prescribing, but to maintain close contact to overcome technical and motivational barriers and to ensure that the novel application is used. However, this is difficult for physicians and psychotherapists due to the critical healthcare system situation in Germany described above. Another support system is needed. Hence, the main hypothesis of this study is that the additional implementation of digital nurses leads to a higher percentage of older patients with depressive symptoms starting DiGA use compared to a prescription and information alone.
Methods: Two DiGA for mild to moderate depression in older patients were available and permanently approved at the time of the funding application. Using the most suitable one of them, as shown in a pilot study, the feasibility of implementation will be examined within a randomized proof of concept study. In our study, a digital nurse is trained to support patients with depression in using a DiGA. The main outcome is DiGA use (first session started: yes/no) after 8 weeks. Major secondary outcomes are patient-relevant outcomes, feasibility of recruitment and intervention, and factors moderating the effect or predicting DiGA use in the target group. Best practice guidelines will be elaborated on how to support and improve DiGA prescription and successful use in this population.
Discussion: In Germany, the approved DiGA are currently little used, especially by people with a low digital affinity. This proof of concept study will use the example of older people with depressive disorders to show whether it is possible to increase the usage rate of a DiGA with the support of a digital nurse so that a DiGA can become a serious therapy option.
Trial Registration: DRKS: DRKS00033535. Registered on February 2, 2024.
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http://www.ncbi.nlm.nih.gov/pmc/articles/PMC11983796 | PMC |
http://dx.doi.org/10.1186/s13063-025-08809-7 | DOI Listing |
J Med Internet Res
September 2025
Institute for Health Care Management and Research, University of Duisburg-Essen, Essen, Germany.
Background: Mental and behavioral disorders affect approximately 28% of the adult population in Germany per year, with treatment being provided through a diverse health care system. Yet there are access and capacity problems in outpatient mental health care. One innovation that could help reduce these barriers and improve the current state of care is the use of mobile health (mHealth) apps, known in Germany as Digitale Gesundheitsanwendungen (DiGA).
View Article and Find Full Text PDFCell Rep Med
September 2025
Department of Molecular, Cellular, and Developmental Biology, University of California, Santa Barbara, Santa Barbara, CA 93106, USA. Electronic address:
Polycystic kidney disease (PKD) is characterized by the development of fluid-filled kidney cysts and relentless progression to renal failure. Current treatments have adverse effects and limited efficacy, enhancing the need for improved therapeutics. Here, we provide a proof of concept for the use of dimeric immunoglobulin A (IgA) (dIgA) monoclonal antibodies (mAbs) to target epithelial-enclosed cysts, by exploiting their ability to transcytose via the polymeric immunoglobulin receptor highly expressed on renal cyst-lining cells.
View Article and Find Full Text PDFJ Med Internet Res
August 2025
Department of Health Care Management, Faculty of Economics and Management, Technische Universität Berlin, Straße des 17. Juni 135, Berlin, 10623, Germany, 49 30 31428732.
Background: While research on the efficacy of digital health applications (DiHA) is progressing, health economic evaluations (EEs) remain limited but are urgently needed to guide reimbursement and coverage decisions. Existing health policy frameworks frequently overlook cost-effectiveness considerations, and many studies presuppose cost savings without sufficient empirical validation. Although previous reviews have assessed digital health interventions more broadly, none has specifically focused on the cost-effectiveness of those intended for independent patient use.
View Article and Find Full Text PDFNervenarzt
September 2025
Bundesinstitut für Arzneimittel und Medizinprodukte (BfArM), Kurt-Georg-Kiesinger-Allee 3, 53175, Bonn, Deutschland.
Since 2020 digital health applications, or DiGA for short, can be prescribed and reimbursed by health insurance companies, making them one of the pioneers in the integration of digital therapeutics in patient care. The prerequisite for these "apps on prescription" is a listing in the DiGA directory after successfully passing an evaluation process at the Federal Institute for Drugs and Medical Devices (BfArM). The DiGA directory of the BfArM contains information on the individual DiGAs and their properties that are transparent and tailored to the target group.
View Article and Find Full Text PDFFront Public Health
August 2025
Medical Faculty, Institute of Social Medicine and Health Systems Research, Otto-von-Guericke University Magdeburg, Magdeburg, Germany.