Applying the Participatory Slow Design Approach to a mHealth Application for Family Caregivers in Pediatric Ear, Nose, and Throat Surgery.

Pediatric ear, nose, and throat (ENT) surgery is very common, and its outcomes may improve with family education. In this regard, mobile health (mHealth) applications (apps), which are on the rise due to digital transformation, can be beneficial in healthcare. This study outlines the user-centered design and development of a mHealth app (version 5.15.0) to support family caregivers during the perioperative process of pediatric ENT surgery. Conducted over two years in an Italian maternal and child health hospital (January 2020-May 2022), the study employed a participatory design method based on the Information System Research (ISR) framework and guided by the principles of Slow Medicine. Utilizing the Relevance, Rigor, and Design cycles of the ISR framework, the mHealth app's content, functionalities, and technical features were defined and developed. A committee of fifteen experts guided the process with input from 25 family caregivers and 24 healthcare providers enrolled in the study. The mHealth app content was structured around five crucial educational moments characterizing the ENT perioperative period, providing evidence-based information on surgical procedures, strategies for preparing children for hospitalization and surgery, pain management, and post-discharge care. The mHealth app featured a function that sends customized notifications to guide caregivers at specific perioperative stages. The development of mHealth apps by implementing a rigorous, participatory, and Slow design process can foster accessible and family-centered information and care in the field of maternal and child health and beyond.

Study protocol for a randomised controlled trial to determine the effectiveness of a mHealth application as a family supportive tool in paediatric otolaryngology perioperative process (TONAPP).

BACKGROUND: Otorhinolaryngology (ORL) surgery is common in children, but hospitalisation, surgery, and home care after discharge are stressful experiences for young patients and their family caregivers. Findings from literature highlight a lack of time in hospitals to support ORL surgery children and their caregivers through the perioperative process, along with the risks of caregivers' autonomous web or social media resources investigation. Therefore, this study aims to evaluate the effectiveness of a mobile health application with content to support ORL patients and their caregivers in the perioperative period to reduce caregiver anxiety and child distress compared to standard care. METHODS: An open-label, two-arm randomised control trial design is being adopted. The intervention consists of a mobile health application with content to support ORL patients and their caregivers during the perioperative period. One hundred eighty participants will be enrolled and randomly assigned to the experimental group using the mHealth application or the control group. The control group receives standard information and education about the ORL perioperative period from healthcare providers orally or through brochures. The primary outcome is the difference between the intervention and control groups in preoperative caregiver state anxiety. Secondary outcome measures include children's distress before surgery and family preparation for hospitalisation. DISCUSSION: The results of this study will be critical to the implementation of a new and safe model for the management of care and education in paediatrics. This model can achieve positive organisational and health outcomes by supporting continuity of care and empowering citizens to have informed participation and satisfaction in paediatric health promotion and management. TRIAL REGISTRATION: Trial identifier: NCT05460689 registry name: ClinicalTrials.gov. Date of registration: July 15, 2022. Last update posted: February 23, 2023.

CARE 1000: randomized controlled trial for the evaluation of the effectiveness of a mHealth app for supporting the first 1000 days of life.

BACKGROUND: Recent developments in eHealth and mobile health (mHealth), as well as the introduction of information and communication technology innovations in clinical practice, such as telemedicine, telemonitoring, and remote examinations, are already changing the current scenario and will continue to generate innovations in the coming decades. The widespread use of mobile devices, with an estimated nearly 30 billion devices and more than 325,000 apps worldwide, will provide various opportunities for people to take control of their own health. Already in 2017, most of the apps available were focused on pregnancy support, more than any other medical field. There have been some reported experiences with social media and mHealth that could benefit the promotion of maternal physical and mental health during pregnancy. However, many apps targeting the first 1000 days of a child's life do not consider the continuity between the prenatal and postnatal periods and their joint impact on maternal and child health. The aim of this study is to evaluate the effectiveness of this mHealth app to support women during the first 1000 days (from conception to 24 months of age) and to improve health prevention behaviours such as immunizations during pregnancy, weight gain during pregnancy, abstinence from smoking and alcohol consumption, and adherence to the routine childhood immunization schedule. In addition, the study aims to understand the level of appreciation of this mHealth app as a tool to overcome information and communication gaps between patients and institutions. METHODS: Conduction of a randomized controlled trial. DISCUSSION: Our results will be relevant for improving this mHealth app to promote health and prevention and to support the first 1000 days of life for both mother and child. Our results will be relevant to the future expansion of such an mHealth app to promote positive health-related outcomes in patients and co-user satisfaction and to support the organization of health services. TRIAL REGISTRATION: ClinicalTrials.gov NCT05500339.

Gaps and Future Challenges of Italian Apps for Pregnancy and Postnatal Care: Systematic Search on App Stores.

BACKGROUND: Despite the availability of thousands of health apps worldwide, when considering those addressing children's first 1000 days of life, most apps fail to consider the continuity between the prenatal and postnatal stages, and their joint impact on maternal and child health. The reliability, quality, and effectiveness of these apps are largely unknown, and the provided content seems questionable in terms of completeness, updating, and trustworthiness. OBJECTIVE: This study evaluates available Italian pregnancy and postnatal care apps to highlight the main gaps to be overcome and the resulting future challenges to be met in this mobile health-related field. METHODS: A systematic search was conducted on the Apple App Store and Google Play Store, and basic information was collected for all identified apps. After deduplication and further selection based on the exclusion criteria, an in-depth analysis of each app was performed by two researchers independently. A 71-item six-domain questionnaire about the desirable features of apps was used to assess information, functionalities, and technical features, while the Mobile Application Rating Scale (MARS) was employed for app quality evaluation. RESULTS: From an initial sample of 684 apps, 22 were deeply analyzed. Most apps did not fulfill the expectations, as just one achieved 50% of all desirable aspects. Postnatal care and counselling for both the mother and child was the least accomplished domain. Moreover, the quality of app information was generally rated more negatively than the quality of their functionality and esthetic features. The lacking aspects were information about methods for postpartum family planning and birth spacing (1/22, 5%) and immunization (2/22, 9%). CONCLUSIONS: The identified gaps could serve as a basis for designing and implementing increasingly high-quality, targeted, and effective apps for pregnancy and postnatal health care, which provide comprehensive, reliable, and evidence-based information, as well as appropriate esthetic and functional characteristics, with relevant implications in terms of maternal and newborn health prevention and promotion.