Mixed-methods study protocol to identify expectations of people with type 1 diabetes and their caregivers about voice-based digital health solutions to support the management of diabetes distress: The PsyVoice study

Introduction Type 1 diabetes (T1D) requires continuous management to obtain a good metabolic control and prevent acute complications. This often affects psychological well-being. People with T1D frequently report diabetes distress (DD). Psychological issues can negatively affect metabolic control and well-being. New technologies can improve quality of life, reduce the treatment burden and improve glycaemic control. Voice technology may serve as an innovative and inexpensive remote monitoring device to evaluate psychological well-being. Tailoring digital health interventions according to the ability and interest of their intended € end-users' increases the acceptability of the intervention itself. PsyVoice explores the perspectives and needs of people with T1D on voice-based digital health interventions to manage DD. Methods and analysis PsyVoice is a mixed-methods study with qualitative and quantitative data sources. For the qualitative part, the researchers will invite 20 people with a T1D or caregivers of children with T1D to participate in in-depth semi-structured interviews. They will be invited as well to answer three questionnaires to assess socio-demographics, diabetes management, e-Health literacy and diabetes distress. Information from questionnaires will be integrated with themes developed in the qualitative analysis of the interviews. People with T1D will be invited to participate in the protocol and give feedback on interview guides, questionnaires, information sheets and informed consent. Ethics and dissemination PsyVoice received ethical approval from Luxembourg's National Research Ethics Committee. Participants will receive information about the purpose, risks and strategies to ensure the confidentiality and anonymity of the study. The results of PsyVoice will guide the selection and development of voice-based technological interventions for managing DD. The outcome will be disseminated to academic and non-academic stakeholders through peer-reviewed open-access journals and a lay public report. Trial registration number This study is registered on ClinicalTrials.gov with the number NCT05517772.