Improving diabetic patients' adherence to treatment and prevention of cardiovascular disease (Office Guidelines Applied to Practice-IMPACT Study)-a cluster randomized controlled effectiveness trial.

Improving diabetic patients' adherence to treatment and prevention of cardiovascular disease (Office Guidelines Applied to Practice-IMPACT Study)-a cluster randomized controlled effectiveness trial.
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改善糖尿病患者遵守心血管疾病的治疗和预防(应用于实践影响研究的办公指南) - 一项群集随机对照有效性试验。

DOI:
10.1186/s13063-022-06581-6
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发表时间:
2022-08-15
期刊:
影响因子:
2.5
通讯作者:
--
中科院分区:
医学4区
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--
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尽管全国范围内心血管疾病(CVD)死亡率和发病率有所改善,但2型糖尿病(T2 DM)成人的CVD死亡率是非T2 DM成人的2-4倍。这些不良健康结果的一个关键因素是药物不依从性。21%至42%的T2 DM患者不按处方服用血糖、血压(BP)或他汀类药物。促进和加强以患者为中心的沟通的干预措施在改善健康结果方面显示出希望。然而,它们尚未得到广泛实施,部分原因是缺乏令人信服的证据证明它们在现实生活中的初级保健环境中的有效性。这项实用的随机分组试验将12个联邦合格医疗保健中心(FATHCs)的17个团队随机分为两个实验组:干预组(第1组):Gap+短信与对照组(第2组):仅发短信。EST-GAP(应用于实践的指南)是一种患者激活干预措施,通过对患者和提供者进行共享决策(SDM)和使用基于指南的检查表的简短培训,改善沟通和患者-提供者伙伴关系。短信干预(Way 2 Health)是一种手机短信服务,告知并鼓励患者坚持目标,坚持药物使用并改善沟通。招募后,第1组和第2组的患者均将参加(1)一次由经过培训的研究助理进行的计划组访视(90-120分钟),以及(2)在0-1、3、6、9和12个月组访视后与其提供者进行随访访视。将在12个月的干预期内收集数据。我们的主要结果是使用eCAP电子监测和自我报告测量的药物依从性。次要结局是(a)采用英国前瞻性糖尿病研究(UKPDS)引擎评分测量的糖尿病特异性5年CVD风险,(B)采用CollaboRATE共享决策测量测量的提供者参与度,以及(c)患者激活测量(PAM)。这项研究将提供一个严格的实用性评估的有效性相结合的mHealth,和患者激活干预相比,单独的mHealth,针对患者和医疗服务提供者在安全网健康中心,在提高药物依从性和降低心血管疾病的风险.鉴于20-50%的慢性病成年人表现出药物不依从性,增加依从性对于改善CVD结果以及节省医疗费用至关重要。ClinicalTrials.gov的注册号是NCT 04874116。在线版本包含补充材料,可通过10.1186/s13063-022-06581-6获得。
Despite nationwide improvements in cardiovascular disease (CVD) mortality and morbidity, CVD deaths in adults with type 2 diabetes (T2DM) are 2–4 times higher than among those without T2DM. A key contributor to these poor health outcomes is medication non-adherence. Twenty-one to 42% of T2DM patients do not take blood sugar, blood pressure (BP), or statin medications as prescribed. Interventions that foster and reinforce patient-centered communication show promise in improving health outcomes. However, they have not been widely implemented, in part due to a lack of compelling evidence for their effectiveness in real-life primary care settings. This pragmatic cluster-randomized trial randomizes 17 teams in 12 Federally Qualified Healthcare Centers (FQHCs) to two experimental groups: intervention (group 1): Office-Gap + Texting vs. control (group 2): Texting only. Office-GAP (Office-Guidelines Applied to Practice) is a patient activation intervention to improve communication and patient-provider partnerships through brief patient and provider training in shared decision-making (SDM) and use of a guideline-based checklist. The texting intervention (Way2Health) is a cell phone messaging service that informs and encourages patients to adhere to goals, adhere to medication use and improve communication. After recruitment, patients in groups 1 and 2 will both attend (1) one scheduled group visit, (90–120 min) conducted by trained research assistants, and (2) follow-up visits with their providers after group visit at 0–1, 3, 6, 9, and 12 months. Data will be collected over 12-month intervention period. Our primary outcome is medication adherence measured using eCAP electronic monitoring and self-report. Secondary outcomes are (a) diabetes-specific 5-year CVD risk as measured with the UK Prospective Diabetes Study (UKPDS) Engine score, (b) provider engagement as measured by the CollaboRATE Shared-Decision Making measure, and (c) patient activation measures (PAM). This study will provide a rigorous pragmatic evaluation of the effectiveness of combined mHealth, and patient activation interventions compared to mHealth alone, targeting patients and healthcare providers in safety net health centers, in improving medication adherence and decreasing CVD risk. Given that 20–50% of adults with chronic illness demonstrate medication non-adherence, increasing adherence is essential to improve CVD outcomes as well as healthcare cost savings. The ClinicalTrials.gov registration number is NCT04874116. The online version contains supplementary material available at 10.1186/s13063-022-06581-6.
DOI: 10.1037/0022-3514.51.6.1173
发表时间: 1986-12-01
影响因子: 7.6
作者:
BARON, RM;KENNY, DA
通讯作者: KENNY, DA
DOI: 10.1111/j.1742-1241.2008.01872.x
发表时间: 2008-10-01
影响因子: 2.6
作者:
Benner, J. S.;Erhardt, L.;Girerd, X.
通讯作者: Girerd, X.
DOI: 10.2337/dc19s010
发表时间: 2019-01-01
期刊: DIABETES CARE
影响因子: 16.2
作者:
Cefalu, William T.;Berg, Erika Gebel;Robinson, Shamera
通讯作者: Robinson, Shamera
DOI: 10.1001/jama.282.24.2313
发表时间: 1999-12-22
影响因子: 120.7
作者:
Braddock, CH;Edwards, KA;Levinson, W
通讯作者: Levinson, W
DOI: 10.1111/j.1751-7176.2011.00427.x
发表时间: 2011-06
期刊: Journal of clinical hypertension (Greenwich, Conn.)
影响因子: --
作者:
Rose AJ;Glickman ME;D'Amore MM;Orner MB;Berlowitz D;Kressin NR
通讯作者: Kressin NR