The Support, Educate, Empower personalized glaucoma coaching trial design.

The Support, Educate, Empower personalized glaucoma coaching trial design.
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DOI:
10.1177/17407745221136571
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发表时间:
2023-04
期刊:
Clinical trials (London, England)
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--
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其他
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青光眼是一种慢性疾病,影响着300万美国人。青光眼通常是无症状的,直到病程很晚的时候,治疗更加困难,而且已经发生了广泛的周边视力丧失。每天服用药物可以减轻这种视力损失,但至少有一半的青光眼患者没有定期服用处方药物。这项研究的目的是利用支持、教育、授权(参见)个性化指导计划,改善那些接受药物治疗的青光眼患者和自我报告依从性较差的人的青光眼用药依从性。这项研究是一项两点随机对照试验,招募了230名自我报告的青光眼用药依从性较差的参与者。这项试验有两个手臂,一个干预手臂和一个控制手臂。干预组的参与者在六个月的时间里从训练有素的非医生干预者那里接受个性化的青光眼教育和基于动机访谈的指导,为期三次面对面的会议,两次访问之间的电话呼叫要求签到,其中向参与者报告当前的遵守水平。参与者还可以选择使用视觉、音频、文本或自动电话用药剂量提醒。控制组的参与者继续与他们的医生进行常规护理,并在三次面对面指导课程的同时通过邮件接收非个性化的青光眼教育材料,以控制青光眼知识内容。所有参与者都会接受药物依从性监测。主要结果是六个月期间按计划服用处方剂量的比例。次要结果是青光眼相关的痛苦。探索性结果是眼压。我们正在测试的个性化教育和基于动机访谈的干预措施是全面的,因为它解决了青光眼患者遇到的广泛的坚持障碍。利用定制的基于Web的应用程序来生成个性化内容和基于激励性访谈的提示来指导指导课程,这将使该计划既可复制又可扩展,并可利用训练有素的非医生提供者集成到临床护理中。虽然这种自我管理支持目前不能像糖尿病那样报销青光眼,但如果干预被发现有效,这项试验可能有助于塑造未来的政策变化。
Glaucoma is a chronic disease that affects 3 million Americans. Glaucoma is most often asymptomatic until very late in its course when treatment is more difficult and extensive peripheral vision loss has already occurred. Taking daily medications can mitigate this vision loss, but at least half of people with glaucoma do not take their prescribed medications regularly. The purpose of this study is to improve glaucoma medication adherence among those with medically treated glaucoma and poor self-reported adherence using the Support, Educate, Empower (SEE) personalized coaching program. This study is a two-site randomized controlled trial enrolling 230 participants with poor self-reported glaucoma medication adherence. The trial has two arms, an intervention arm and a control arm. Participants in the intervention arm receive personalized glaucoma education and motivational interviewing-based coaching over six months from a trained non-physician interventionist for three in-person sessions with between visit phone calls for checkins where current adherence level is reported to participants. Participants also can elect to have visual, audio, text or automated phone call medication dose reminders. Participants in the control arm continue usual care with their physician and receive non-personalized glaucoma educational materials via mail in parallel to the three in-person coaching sessions to control for glaucoma knowledge content. All participants receive a medication adherence monitor. The primary outcome is the proportion of prescribed doses taken on schedule during the six-month period. The secondary outcome is glaucoma related distress. The exploratory outcome is intraocular pressure. The personalized education and motivational-interviewing based intervention that we are testing is comprehensive in that it addresses the wide range of barriers to adherence that people with glaucoma encounter. Leveraging a custom-built web-based application to generate the personalized content and the motivational-interviewing based prompts to guide the coaching sessions will make this program both replicable and scalable and can be integrated into clinical care utilizing trained non-physician providers. Though this type of self-management support is not currently reimbursed for glaucoma as it is for diabetes, this trial could help shape future policy change should the intervention be found effective.
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