Xu Yue, Huang Qiyuan, Teng Shuang, Wang Yulong, Sun Huabei, Li Mei, Li Junxin, Zhu Muwei, Tang Xianping
School of Nursing, Xuzhou Medical University, Xuzhou, Jiangsu, China.
School of Nursing, Fujian Medical University, Fuzhou, Fujian, China.
Digit Health. 2025 Mar 18;11:20552076251326218. doi: 10.1177/20552076251326218. eCollection 2025 Jan-Dec.
To describe a study protocol for a three-arm randomized controlled trial that will evaluate the effectiveness of an Aged Smart-Care (ASC) application program intervention for community-dwelling older adults in China.
This randomized controlled trial with three arms will be conducted at eight community health service centers. Participants will be randomly assigned to one of three groups: the interactive ASC (ASC + I) group, the regular ASC group, or the control group. The ASC + I group will receive management from a multidisciplinary medical team, while the regular ASC group will only utilize the ASC. The primary outcome will be assessed using the Medical Outcomes Study Short Form 36 (SF-36) Health Survey. The secondary outcomes include general self-efficacy, medication adherence, effectiveness of health behavior interventions, BMI, number of outpatient visits, and number of hospitalizations. Data will be collected at baseline, immediately post-intervention, 3 months, 6 months, and 1 year after the intervention. Generalized estimating equations model will be employed for data analysis.
This study clarifies the development process of the ASC and designs a three-arm randomized controlled trial to examine the efficacy of the ASC for older adults in the community. The results of the study will compare differences in the quality of life of participants in different groups. This will help community healthcare workers to choose appropriate interventions regarding the ASC. Furthermore, this provides scientific guidance for the Integrated Theory of Health Behavior Change theory in the field of mobile health tool development.
描述一项三臂随机对照试验的研究方案,该试验将评估老年智能照护(ASC)应用程序干预对中国社区居住老年人的有效性。
这项三臂随机对照试验将在八个社区卫生服务中心进行。参与者将被随机分配到三组中的一组:交互式ASC(ASC + I)组、常规ASC组或对照组。ASC + I组将接受多学科医疗团队的管理,而常规ASC组将仅使用ASC。主要结局将使用医学结局研究简表36(SF - 36)健康调查进行评估。次要结局包括一般自我效能感、药物依从性、健康行为干预的有效性、体重指数、门诊就诊次数和住院次数。数据将在基线、干预后即刻、干预后3个月、6个月和1年时收集。数据分析将采用广义估计方程模型。
本研究阐明了ASC的开发过程,并设计了一项三臂随机对照试验,以检验ASC对社区老年人的疗效。研究结果将比较不同组参与者生活质量的差异。这将有助于社区医护人员选择关于ASC的合适干预措施。此外,这为移动健康工具开发领域的健康行为改变综合理论提供了科学指导。