Effect of a Comprehensive Telehealth Intervention vs Telemonitoring and Care Coordination in Patients With Persistently Poor Type 2 Diabetes Control: A Randomized Clinical Trial.
Effect of a Comprehensive Telehealth Intervention vs Telemonitoring and Care Coordination in Patients With Persistently Poor Type 2 Diabetes Control: A Randomized Clinical Trial.
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DOI：
10.1001/jamainternmed.2022.2947
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发表时间：
2022-09-01
影响因子：
39
通讯作者：
Edelman, David
中科院分区：
文献类型：
--
作者：
Crowley, Matthew J.;Tarkington, Phillip E.;Bosworth, Hayden B.;Jeffreys, Amy S.;Coffman, Cynthia J.;Maciejewski, Matthew L.;Steinhauser, Karen;Smith, Valerie A.;Dar, Moahad S.;Fredrickson, Sonja K.;Mundy, Amy C.;Strawbridge, Elizabeth M.;Marcano, Teresa J.;Overby, Donna L.;Elliott, Nadya T. Majette;Danus, Susanne;Edelman, David
2 型糖尿病 (PPDM) 持续控制不佳很常见，并会导致不良预后。全面的远程医疗干预措施可以帮助解决 PPDM，但有效性尚不确定，并且存在阻碍其在临床实践中使用的障碍。通过将实用的综合远程医疗干预措施与更简单的远程医疗方法进行比较，解决阻碍 PPDM 使用综合远程医疗的证据差距。这项主动比较、平行组、随机临床试验是在 2 个退伍军人事务部医疗保健系统中进行的。从2018年12月到2020年1月，对1128名PPDM门诊患者进行了资格评估，其中200名患者被随机分组； PPDM 的定义是，尽管接受了基于临床的初级护理和/或糖尿病专科护理，但糖化血红蛋白 (HbA1c) 水平仍维持在 8.5% 或更高水平达 1 年或更长时间。数据分析于 2021 年 3 月至 2022 年 5 月期间进行。每项为期 12 个月的干预措施均由护士实施，且仅使用临床人员/资源。综合远程医疗组（n = 101）接受远程监控、自我管理支持、饮食/活动支持、药物管理和抑郁症支持。分配到较简单干预的患者 (n = 99) 接受远程监护和护理协调。使用意向治疗线性混合纵向模型在 12 个月内分析主要 (HbA1c) 和次要结局（糖尿病困扰、糖尿病自我护理、自我效能、体重指数、抑郁症状）。通过多重插补和纳入临床数据的敏感性分析检查了缺失 HbA1c 测量值的影响。检查了不良事件和干预成本。人口 (n = 200) 的平均 (SD) 年龄为 57.8 (8.2) 岁； 45 名 (22.5%) 为女性，144 名 (72.0%) 为黑人，11 名 (5.5%) 为西班牙裔/拉丁裔。从基线到 12 个月，综合远程医疗组的 HbA1c 变化为 -1.59%（10.17% 至 8.58%），远程监测/护理协调组为 -0.98%（10.17% 至 9.19%），估计平均差为 -0.61%（95% CI，-1.12% 至 -0.11%；P = .02）。敏感性分析显示了类似的结果。 12 个月时，接受全面远程医疗的患者在糖尿病困扰、糖尿病自我护理和自我效能方面有显着改善；没有观察到体重指数或抑郁症的差异。各组之间的不良事件相似。综合远程医疗每年为每位患者额外花费 1519 美元。这项随机临床试验发现，与远程监护/护理协调相比，综合远程医疗以合理的额外成本改善了 PPDM 患者的多种结局。这项研究支持考虑在具有适当基础设施的系统中全面实施 PPDM 远程医疗，并可能在 COVID-19 大流行期间及之后提高远程医疗的价值。 ClinicalTrials.gov 标识符：NCT03520413
Persistently poorly controlled type 2 diabetes (PPDM) is common and causes poor outcomes. Comprehensive telehealth interventions could help address PPDM, but effectiveness is uncertain, and barriers impede use in clinical practice. To address evidence gaps preventing use of comprehensive telehealth for PPDM by comparing a practical, comprehensive telehealth intervention to a simpler telehealth approach. This active-comparator, parallel-arm, randomized clinical trial was conducted in 2 Veterans Affairs health care systems. From December 2018 to January 2020, 1128 outpatients with PPDM were assessed for eligibility and 200 were randomized; PPDM was defined as maintenance of hemoglobin A1c (HbA1c) level of 8.5% or higher for 1 year or longer despite engagement with clinic-based primary care and/or diabetes specialty care. Data analyses were preformed between March 2021 and May 2022. Each 12-month intervention was nurse-delivered and used only clinical staffing/resources. The comprehensive telehealth group (n = 101) received telemonitoring, self-management support, diet/activity support, medication management, and depression support. Patients assigned to the simpler intervention (n = 99) received telemonitoring and care coordination. Primary (HbA1c) and secondary outcomes (diabetes distress, diabetes self-care, self-efficacy, body mass index, depression symptoms) were analyzed over 12 months using intent-to-treat linear mixed longitudinal models. Sensitivity analyses with multiple imputation and inclusion of clinical data examined the impact of missing HbA1c measurements. Adverse events and intervention costs were examined. The population (n = 200) had a mean (SD) age of 57.8 (8.2) years; 45 (22.5%) were women, 144 (72.0%) were of Black race, and 11 (5.5%) were of Hispanic/Latinx ethnicity. From baseline to 12 months, HbA1c change was −1.59% (10.17% to 8.58%) in the comprehensive telehealth group and −0.98% (10.17% to 9.19%) in the telemonitoring/care coordination group, for an estimated mean difference of −0.61% (95% CI, −1.12% to −0.11%; P = .02). Sensitivity analyses showed similar results. At 12 months, patients receiving comprehensive telehealth had significantly greater improvements in diabetes distress, diabetes self-care, and self-efficacy; no differences in body mass index or depression were seen. Adverse events were similar between groups. Comprehensive telehealth cost an additional $1519 per patient per year to deliver. This randomized clinical trial found that compared with telemonitoring/care coordination, comprehensive telehealth improved multiple outcomes in patients with PPDM at a reasonable additional cost. This study supports consideration of comprehensive telehealth implementation for PPDM in systems with appropriate infrastructure and may enhance the value of telehealth during the COVID-19 pandemic and beyond. ClinicalTrials.gov Identifier: NCT03520413
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影响因子：
13.3
作者：
Donnelly, L. A.;Morris, A. D.;Evans, J. M. M.
通讯作者：
Evans, J. M. M.
影响因子：
16.2
作者：
通讯作者：
--
影响因子：
2.2
作者：
Kobe EA;Edelman D;Tarkington PE;Bosworth HB;Maciejewski ML;Steinhauser K;Jeffreys AS;Coffman CJ;Smith VA;Strawbridge EM;Szabo ST;Desai S;Garrett MP;Wilmot TC;Marcano TJ;Overby DL;Tisdale GA;Durkee M;Bullard S;Dar MS;Mundy AC;Hiner J;Fredrickson SK;Majette Elliott NT;Howard T;Jeter DH;Danus S;Crowley MJ
通讯作者：
Crowley MJ
影响因子：
6.8
作者：
AKAIKE, H
通讯作者：
AKAIKE, H
影响因子：
5.1
作者：
Hartz, Arthur;Kent, Sarah;Daly, Jeanette
通讯作者：
Daly, Jeanette