Wang Jitao, Wu Zhenke, Choi Sung Won, Sen Srijan, Yan Xinghui, Miner Jennifer A, Sander Angelle M, Lyden Angela K, Troost Jonathan P, Carlozzi Noelle E
Department of Biostatistics, School of Public Health, University of Michigan, Ann Arbor, MI, United States.
Michigan Institute for Data Science, University of Michigan, Ann Arbor, MI, United States.
JMIR Form Res. 2023 Sep 14;7:e43099. doi: 10.2196/43099.
Caregivers of people with chronic illnesses often face negative stress-related health outcomes and are unavailable for traditional face-to-face interventions due to the intensity and constraints of their caregiver role. Just-in-time adaptive interventions (JITAIs) have emerged as a design framework that is particularly suited for interventional mobile health studies that deliver in-the-moment prompts that aim to promote healthy behavioral and psychological changes while minimizing user burden and expense. While JITAIs have the potential to improve caregivers' health-related quality of life (HRQOL), their effectiveness for caregivers remains poorly understood.
The primary objective of this study is to evaluate the dose-response relationship of a fully automated JITAI-based self-management intervention involving personalized mobile app notifications targeted at decreasing the level of caregiver strain, anxiety, and depression. The secondary objective is to investigate whether the effectiveness of this mobile health intervention was moderated by the caregiver group. We also explored whether the effectiveness of this intervention was moderated by (1) previous HRQOL measures, (2) the number of weeks in the study, (3) step count, and (4) minutes of sleep.
We examined 36 caregivers from 3 disease groups (10 from spinal cord injury, 11 from Huntington disease, and 25 from allogeneic hematopoietic cell transplantation) in the intervention arm of a larger randomized controlled trial (subjects in the other arm received no prompts from the mobile app) designed to examine the acceptability and feasibility of this intensive type of trial design. A series of multivariate linear models implementing a weighted and centered least squares estimator were used to assess the JITAI efficacy and effect.
We found preliminary support for a positive dose-response relationship between the number of administered JITAI messages and JITAI efficacy in improving caregiver strain, anxiety, and depression; while most of these associations did not meet conventional levels of significance, there was a significant association between high-frequency JITAI and caregiver strain. Specifically, administering 5-6 messages per week as opposed to no messages resulted in a significant decrease in the HRQOL score of caregiver strain with an estimate of -6.31 (95% CI -11.76 to -0.12; P=.046). In addition, we found that the caregiver groups and the participants' levels of depression in the previous week moderated JITAI efficacy.
This study provides preliminary evidence to support the effectiveness of the self-management JITAI and offers practical guidance for designing future personalized JITAI strategies for diverse caregiver groups.
ClinicalTrials.gov NCT04556591; https://clinicaltrials.gov/ct2/show/NCT04556591.
慢性病患者的照料者常常面临与负面压力相关的健康问题，且由于其照料者角色的强度和限制，无法参与传统的面对面干预。即时自适应干预（JITAIs）已成为一种设计框架，特别适用于介入式移动健康研究，这种研究能提供即时提示，旨在促进健康行为和心理变化，同时将用户负担和费用降至最低。虽然JITAIs有潜力改善照料者的健康相关生活质量（HRQOL），但其对照料者的有效性仍知之甚少。
本研究的主要目的是评估基于JITAI的全自动自我管理干预的剂量反应关系，该干预涉及个性化移动应用通知，旨在降低照料者的压力、焦虑和抑郁水平。次要目的是调查这种移动健康干预的有效性是否因照料者群体而异。我们还探讨了这种干预的有效性是否受到以下因素的调节：（1）先前的HRQOL测量值；（2）研究中的周数；（3）步数；（4）睡眠时间。
我们在一项更大的随机对照试验的干预组中检查了来自3个疾病组的36名照料者（脊髓损伤组10名，亨廷顿病组11名，异基因造血细胞移植组25名）（另一组受试者未收到移动应用的提示），该试验旨在检验这种强化试验设计的可接受性和可行性。使用一系列实施加权和中心化最小二乘估计器的多元线性模型来评估JITAI的疗效和效果。
我们初步发现，所发送的JITAI消息数量与JITAI在改善照料者压力、焦虑和抑郁方面的疗效之间存在正剂量反应关系；虽然这些关联大多未达到传统的显著性水平，但高频JITAI与照料者压力之间存在显著关联。具体而言，每周发送5 - 6条消息而非不发送消息，导致照料者压力的HRQOL评分显著降低，估计值为 - 6.31（95%CI - 11.76至 - 0.12；P = 0.046）。此外，我们发现照料者群体和参与者前一周的抑郁水平调节了JITAI的疗效。
本研究提供了初步证据支持自我管理JITAI的有效性，并为为不同照料者群体设计未来个性化JITAI策略提供了实践指导。
ClinicalTrials.gov NCT04556591；https://clinicaltrials.gov/ct2/show/NCT04556591。
