Kaiser Permanente Division of Research, Oakland, CA.
Kaiser Permanente Colorado Institute for Health Research, Denver, CO.
Diabet Med. 2019 Jan;36(1):52-61. doi: 10.1111/dme.13840. Epub 2018 Nov 7.
To evaluate the effectiveness of automated symptom and side effect monitoring on quality of life among individuals with symptomatic diabetic peripheral neuropathy.
We conducted a pragmatic, cluster randomized controlled trial (July 2014 to July 2016) within a large healthcare system. We randomized 1834 primary care physicians and prospectively recruited from their lists 1270 individuals with neuropathy who were newly prescribed medications for their symptoms. Intervention participants received automated telephone-based symptom and side effect monitoring with physician feedback over 6 months. The control group received usual care plus three non-interactive diabetes educational calls. Our primary outcomes were quality of life (EQ-5D) and select symptoms (e.g. pain) measured 4-8 weeks after starting medication and again 8 months after baseline. Process outcomes included receiving a clinically effective dose and communication between individuals with neuropathy and their primary care provider over 12 months. Interviewers collecting outcome data were blinded to intervention assignment.
Some 1252 participants completed the baseline measures [mean age (sd): 67 (11.7), 53% female, 57% white, 8% Asian, 13% black, 20% Hispanic]. In total, 1179 participants (93%) completed follow-up (619 control, 560 intervention). Quality of life scores (intervention: 0.658 ± 0.094; control: 0.653 ± 0.092) and symptom severity were similar at baseline. The intervention had no effect on primary [EQ-5D: -0.002 (95% CI -0.01, 0.01), P = 0.623; pain: 0.295 (-0.75, 1.34), P = 0.579; sleep disruption: 0.342 (-0.18, 0.86), P = 0.196; lower extremity functioning: -0.079 (-1.27, 1.11), P = 0.896; depression: -0.462 (-1.24, 0.32); P = 0.247] or process outcomes.
Automated telephone monitoring and feedback alone were not effective at improving quality of life or symptoms for people with symptomatic diabetic peripheral neuropathy.
ClinicalTrials.gov (NCT02056431).
评估自动化症状和副作用监测对有症状的糖尿病周围神经病变患者生活质量的影响。
我们在一个大型医疗保健系统中进行了一项实用的、集群随机对照试验（2014 年 7 月至 2016 年 7 月）。我们将 1834 名初级保健医生进行随机分组，并前瞻性地从他们的名单中招募了 1270 名新服用药物治疗症状的神经病变患者。干预组接受了为期 6 个月的基于电话的自动化症状和副作用监测，并接受了医生的反馈。对照组接受了常规护理和 3 次非互动性糖尿病教育电话。我们的主要结局是 4-8 周开始服药后和基线后 8 个月的生活质量（EQ-5D）和特定症状（如疼痛）。过程结局包括在 12 个月内获得临床有效剂量和有症状的糖尿病周围神经病变患者与初级保健提供者之间的沟通。收集结局数据的访谈者对干预分配不知情。
共有 1252 名参与者完成了基线测量[平均年龄（标准差）：67（11.7），53%女性，57%白人，8%亚洲人，13%黑人，20%西班牙裔]。共有 1179 名参与者（93%）完成了随访（619 名对照组，560 名干预组）。基线时生活质量评分（干预组：0.658±0.094；对照组：0.653±0.092）和症状严重程度相似。该干预措施对主要结局[EQ-5D：-0.002（95%CI-0.01，0.01），P=0.623；疼痛：0.295（-0.75，1.34），P=0.579；睡眠障碍：0.342（-0.18，0.86），P=0.196；下肢功能：-0.079（-1.27，1.11），P=0.896；抑郁：-0.462（-1.24，0.32），P=0.247]或过程结局均无影响。
单独使用自动化电话监测和反馈并不能改善有症状的糖尿病周围神经病变患者的生活质量或症状。
ClinicalTrials.gov（NCT02056431）。
