Trials · 2025
Implementation of a digital nurse to improve the use of digital health applications (DiGA) for older people with depressive disorders (DiGA4Aged): a randomized proof of concept study.
СтатьяПротокол клинического исследованияНазвание и аннотация: Перевод пока не подготовлен
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Mai Anna, Pape Magdalena, Busse Theresa Sophie, Kunde Katharina, Bosompem Jennifer, Giehl Chantal, Otte Ina Carola, Herpertz Stephan, Juckel Georg, Haussleiter Ida, Wirth Rainer, Vollmar Horst Christian, Timmesfeld Nina, Dieris-Hirche Jan
Аннотация
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.
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.