Practical telehealth to improve control and engagement for patients with clinic-refractory diabetes mellitus (PRACTICE-DM): Protocol and baseline data for a randomized trial.
Practical telehealth to improve control and engagement for patients with clinic-refractory diabetes mellitus (PRACTICE-DM): Protocol and baseline data for a randomized trial.
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DOI：
10.1016/j.cct.2020.106157
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发表时间：
2020-11
影响因子：
2.2
通讯作者：
Crowley MJ
中科院分区：
文献类型：
--
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
持续控制不佳的2型糖尿病（PPDM），或尽管接受了基于临床的糖尿病护理，但血红蛋白A1 c（HbA 1c）仍维持≥8.5%，对国家糖尿病负担的贡献不成比例。全面的远程医疗干预措施可能有助于改善PPDM，但现有的方法很少考虑到临床实施，限制了在常规实践中的使用。我们描述了一项测试新型远程医疗干预措施的研究，该干预措施全面针对临床难治性PPDM，并且是专门为使用现有退伍军人健康管理局（VHA）临床基础设施进行实际交付而开发的。实用的远程医疗，以改善临床难治性糖尿病患者的控制和参与（PRACTICE-DM）是一项正在进行的随机对照试验，比较了两种为期12个月的干预措施：1）标准VHA家庭远程医疗（HT）远程监护/护理协调;或2）PRACTICE-DM干预，一种结合远程监护、自我管理支持、饮食/活动支持、药物管理，和抑郁症管理。主要结果是HbA 1c。次要结局包括糖尿病困扰、自我护理、自我效能、体重、抑郁症状、实施障碍/促进因素和成本。我们假设PRACTICE-DM干预将在12个月内使HbA 1c与标准HT相比降低>0.6%。这项正在进行的试验的入组于2020年1月结束; 200名患者被随机分配（99名接受标准HT，101名接受PRACTICE-DM干预）。该队列的平均年龄为58岁，其中23%为女性，72%为非洲裔美国人。平均基线HbA 1c和BMI分别为10.2%和34.8 kg/m2。由于PRACTICE-DM干预使用现有临床基础设施全面针对PPDM的潜在因素，因此可能非常适合在常规实践中降低PPDM的并发症和成本。
Persistent poorly-controlled type 2 diabetes mellitus (PPDM), or maintenance of a hemoglobin A1c (HbA1c) ≥8.5% despite receiving clinic-based diabetes care, contributes disproportionately to the national diabetes burden. Comprehensive telehealth interventions may help ameliorate PPDM, but existing approaches have rarely been designed with clinical implementation in mind, limiting use in routine practice. We describe a study testing a novel telehealth intervention that comprehensively targets clinic-refractory PPDM, and was explicitly developed for practical delivery using existing Veterans Health Administration (VHA) clinical infrastructure. Practical Telehealth to Improve Control and Engagement for Patients with Clinic-Refractory Diabetes Mellitus (PRACTICE-DM) is an ongoing randomized controlled trial comparing two 12-month interventions: 1) standard VHA Home Telehealth (HT) telemonitoring/care coordination; or 2) the PRACTICE-DM intervention, a comprehensive HT-delivered intervention combining telemonitoring, self-management support, diet/activity support, medication management, and depression management. The primary outcome is HbA1c. Secondary outcomes include diabetes distress, self-care, self-efficacy, weight, depressive symptoms, implementation barriers/facilitators, and costs. We hypothesize that the PRACTICE-DM intervention will reduce HbA1c by >0.6% versus standard HT over 12 months. Enrollment for this ongoing trial concluded in January 2020; 200 patients were randomized (99 to standard HT and 101 to the PRACTICE-DM intervention). The cohort has a mean age of 58 and is 23% female and 72% African American. Mean baseline HbA1c and BMI were 10.2% and 34.8 kg/m2. Because it comprehensively targets factors underlying PPDM using existing clinical infrastructure, the PRACTICE-DM intervention may be well suited to lower the complications and costs of PPDM in routine practice.
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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：
2.2
作者：
Andrews, Sara M.;Sperber, Nina R.;Crowley, Matthew J.
通讯作者：
Crowley, Matthew J.
影响因子：
3.7
作者：
Alexopoulos, Anastasia-Stefania;Jackson, George L.;Crowley, Matthew J.
通讯作者：
Crowley, Matthew J.
影响因子：
3.5
作者：
Brown SA;García AA;Brown A;Becker BJ;Conn VS;Ramírez G;Winter MA;Sumlin LL;Garcia TJ;Cuevas HE
通讯作者：
Cuevas HE
影响因子：
4.7
作者：
Crowley, Matthew J.;Edelman, David;Bosworth, Hayden B.
通讯作者：
Bosworth, Hayden B.