Department of Nursing, the First Affiliated Hospital of Anhui Medical University, Hefei, China.
School of Nursing, Anhui Medical University, Hefei, China.
J Med Internet Res. 2024 Aug 13;26:e53909. doi: 10.2196/53909.
People who undergo sphincter-preserving surgery have high rates of anorectal functional disturbances, known as low anterior resection syndrome (LARS). LARS negatively affects patients' quality of life (QoL) and increases their need for self-management behaviors. Therefore, approaches to enhance self-management behavior and QoL are vital.
This study aims to assess the effectiveness of a remote digital management intervention designed to enhance the QoL and self-management behavior of patients with LARS.
From July 2022 to May 2023, we conducted a single-blinded randomized controlled trial and recruited 120 patients with LARS in a tertiary hospital in Hefei, China. All patients were randomly assigned to the intervention group (using the "e-bowel safety" applet and monthly motivational interviewing) or the control group (usual care and an information booklet). Our team provided a 3-month intervention and followed up with all patients for an additional 3 months. The primary outcome was patient QoL measured using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30. The secondary outcomes were evaluated using the Bowel Symptoms Self-Management Behaviors Questionnaire, LARS score, and Perceived Social Support Scale. Data collection occurred at study enrollment, the end of the 3-month intervention, and the 3-month follow-up. Generalized estimating equations were used to analyze changes in all outcome variables.
In the end, 111 patients completed the study. In the intervention group, 5 patients withdrew; 4 patients withdrew in the control group. Patients in the intervention group had significantly larger improvements in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 total score (mean difference 11.51; 95% CI 10.68-12.35; Cohen d=1.73) and Bowel Symptoms Self-Management Behaviors Questionnaire total score (mean difference 8.80; 95% CI 8.28-9.32; Cohen d=1.94) than those in the control group. This improvement effect remained stable at 3-month follow-up (mean difference 14.47; 95% CI 13.65-15.30; Cohen d=1.58 and mean difference 8.85; 95% CI 8.25-9.42; Cohen d=2.23). The LARS score total score had significantly larger decreases after intervention (mean difference -3.28; 95% CI -4.03 to -2.54; Cohen d=-0.39) and at 3-month follow-up (mean difference -6.69; 95% CI -7.45 to -5.93; Cohen d=-0.69). The Perceived Social Support Scale total score had significantly larger improvements after intervention (mean difference 0.47; 95% CI 0.22-0.71; Cohen d=1.81).
Our preliminary findings suggest that the mobile health-based remote interaction management intervention significantly enhanced the self-management behaviors and QoL of patients with LARS, and the effect was sustained. Mobile health-based remote interventions become an effective method to improve health outcomes for many patients with LARS.
Chinese Clinical Trial Registry ChiCTR2200061317; https://tinyurl.com/tmmvpq3.
接受保肛手术的患者存在较高的肛肠功能障碍发生率，即低位前切除综合征（LARS）。LARS 会降低患者的生活质量（QoL），并增加他们对自我管理行为的需求。因此，增强自我管理行为和 QoL 的方法至关重要。
本研究旨在评估一种远程数字管理干预措施对 LARS 患者 QoL 和自我管理行为的增强效果。
本单盲随机对照试验于 2022 年 7 月至 2023 年 5 月在合肥市的一家三级医院进行，共招募了 120 名 LARS 患者。所有患者均随机分为干预组（使用“e-bowel safety”小程序和每月动机性访谈）或对照组（常规护理和信息手册）。我们的团队提供了 3 个月的干预，并在随后的 3 个月对所有患者进行了随访。主要结局是使用欧洲癌症研究与治疗组织（EORTC）生活质量问卷核心 30 评估患者的 QoL。次要结局使用排便症状自我管理行为问卷、LARS 评分和感知社会支持量表进行评估。数据采集在研究入组时、3 个月干预结束时和 3 个月随访时进行。使用广义估计方程分析所有结局变量的变化。
最终，111 名患者完成了研究。在干预组中，有 5 名患者退出；对照组中有 4 名患者退出。与对照组相比，干预组患者的 EORTC 生活质量问卷核心 30 总分（平均差值 11.51；95%CI 10.68-12.35；Cohen d=1.73）和排便症状自我管理行为问卷总分（平均差值 8.80；95%CI 8.28-9.32；Cohen d=1.94）均有显著改善。这种改善效果在 3 个月随访时仍然稳定（平均差值 14.47；95%CI 13.65-15.30；Cohen d=1.58 和平均差值 8.85；95%CI 8.25-9.42；Cohen d=2.23）。干预后 LARS 评分总分（平均差值-3.28；95%CI -4.03 至-2.54；Cohen d=-0.39）和 3 个月随访时（平均差值-6.69；95%CI -7.45 至-5.93；Cohen d=-0.69）也有显著下降。干预后感知社会支持量表总分（平均差值 0.47；95%CI 0.22-0.71；Cohen d=1.81）也有显著改善。
我们的初步发现表明，基于移动健康的远程交互管理干预显著增强了 LARS 患者的自我管理行为和 QoL，且效果持续。基于移动健康的远程干预成为改善许多 LARS 患者健康结局的有效方法。
中国临床试验注册中心 ChiCTR2200061317；https://tinyurl.com/tmmvpq3。
