Adhera Health, Inc, Palo Alto, CA, USA.
Endocrinology Pediatric Unit, Hospital Universitario Miguel Servet, Zaragoza, Spain.
BMC Med Inform Decis Mak. 2022 Aug 13;22(1):215. doi: 10.1186/s12911-022-01935-1.
Caregivers of children undergoing growth hormone treatment often face stress and stigma. In this regard, family-centered approaches are increasingly considered, wherein caregivers' mental wellbeing is taken into account to optimize children's health-related outcomes and behaviors (e.g., treatment adherence). Here, mindfulness and parenting-based programs have been developed to support the mental wellbeing of caregivers and, in turn, promote richer interactions with the children. Nevertheless, this type of program can face drawbacks, such as the scheduling and availability of family members. Recent digital health (DH) solutions (e.g., mobile apps) are showing promising advantages as self-management support tools for improving wellbeing and behaviors related to the treatments. Although, further evidence is necessary in the field of Growth Hormone Treatment (GHt). Accordingly, this study aims to examine the usability of a mobile DH solution and the feasibility of a DH intervention designed to promote emotional and mental wellbeing of caregivers of children undergoing GHt.
This is a prospective mixed-methods (qualitative-quantitative) exploratory study composed of two sub-studies, including caregivers of children undergoing GHt. Sub-study one (SS1; n = 10) focuses on the usability of the DH solution (detecting potential barriers and facilitators) and an ad hoc semi-structured interview will be administered to the caregivers after using the DH solution for one month. Sub-study two (SS2; n = 55) aims to evaluate the feasibility of the DH intervention on caregivers' perceived distress, positive affectivity, mental wellbeing, self-efficacy, together with the children's quality of life and treatment adherence. All these parameters will be assessed via quantitative methods before and after 3-months of the DH intervention. Usability and engagement will also be assessed during and at the end of the study.
It is expected that significant amounts of data will be captured with regards of the feasibility of the DH solution.
The manuscript provides a complete protocol for a study that will include qualitative and quantitative information about, on one hand, the user-friendliness of the DH solution, and on the other, the effects on caregivers' emotional, as well as, behavioral parameters in terms of the usability and engagement to the DH solution. The findings will contribute to the evidence planning process for the future adoption of digital health solutions for caregiver support and better health-related outcomes. Trial registration ClinicalTrials.gov, ID: NCT04812665.
接受生长激素治疗的儿童的照顾者经常面临压力和耻辱。在这方面，越来越多地考虑以家庭为中心的方法，其中要考虑照顾者的心理健康，以优化儿童的健康相关结果和行为（例如，治疗依从性）。在这里，已经开发了正念和基于育儿的计划，以支持照顾者的心理健康，并进而促进与孩子的更丰富互动。尽管如此，这种类型的计划可能存在缺点，例如家庭成员的日程安排和可用性。最近的数字健康（DH）解决方案（例如，移动应用程序）作为改善与治疗相关的幸福感和行为的自我管理支持工具，显示出有希望的优势。尽管如此，在生长激素治疗（GHt）领域仍需要更多的证据。因此，本研究旨在检查移动 DH 解决方案的可用性以及旨在促进接受 GHt 的儿童的照顾者的情绪和心理健康的 DH 干预措施的可行性。
这是一项前瞻性混合方法（定性-定量）探索性研究，由两项子研究组成，包括接受 GHt 的儿童的照顾者。子研究一（SS1；n=10）侧重于 DH 解决方案的可用性（检测潜在的障碍和促进因素），并在照顾者使用 DH 解决方案一个月后对其进行专门的半结构化访谈。子研究二（SS2；n=55）旨在评估 DH 干预对照顾者感知到的痛苦，积极情感，心理健康，自我效能感的可行性，以及儿童的生活质量和治疗依从性。所有这些参数将通过定量方法在 DH 干预前后 3 个月进行评估。在研究期间和结束时还将评估可用性和参与度。
预计将捕获大量有关 DH 解决方案可行性的数据。
本文提供了一项研究的完整方案，该方案将包括定性和定量信息，一方面是 DH 解决方案的用户友好性，另一方面是对照顾者的情绪以及行为参数的影响，就可用性和对 DH 解决方案的参与度而言。研究结果将有助于为未来采用数字健康解决方案来支持照顾者并改善健康相关结果提供证据规划过程。
ClinicalTrials.gov，ID：NCT04812665。
