Newman-Casey Paula Anne, Niziol Leslie M, Mackenzie Chamisa K, Resnicow Kenneth, Lee Paul P, Musch David C, Heisler Michele
1Department of Ophthalmology and Visual Sciences, University of Michigan Medical School, 1000 Wall Street, Ann Arbor, MI 48105 USA.
2Department of Health Behavior and Health Education, University of Michigan School of Public Health, Ann Arbor, MI 48105 USA.
Pilot Feasibility Stud. 2018 Jul 23;4:128. doi: 10.1186/s40814-018-0320-6. eCollection 2018.
About half of people with glaucoma do not adhere to their recommended medications. Interventions for other chronic conditions have successfully utilized reminder systems and motivational interviewing (MI)-based counseling. This study was designed to pilot a personalized intervention that leverages these strategies to assess their impact on medication adherence in glaucoma patients.
Glaucoma patients taking ≥ 1 medication will be pre-screened by telephone survey for adherence to their medication(s). Those who self-report poor adherence will be enrolled in a 3-month monitoring period to measure medication adherence using electronic medication monitors. Participants who are non-adherent (take </=80% of their medication doses) over the 3-month run in phase will be eligible for the study. We plan to enroll 57 participants who are non-adherent to their medications. Participants' adherence will then be continuously measured with electronic medication monitors, by self-report, and via pharmacy refill data over 2 years, during which two successively more resource-intensive components of an intervention aimed to improve medication adherence will be administered. The first component is a 3-month period of reminders (audio and/or visual) and text message or automated phone call if a dose of medication is not taken within a pre-specified time frame. The second component is a 6-month MI-based counseling program with a trained glaucoma counselor. This component uses the , a computer-based personalized behavior change program that enables para-professional staff to provide personalized education and counseling for glaucoma. The primary outcome is change in medication adherence. The secondary outcomes include changes in clinical outcomes (intraocular pressure, IOP, and IOP fluctuation) and psychosocial mediators of adherence (e.g., competence, energy for change and satisfaction). Participants will undergo semi-structured interviews at 12 months to give feedback about the counseling program in order to improve it.
This pilot study will provide insight into ways to deliver more personalized health care to non-adherent glaucoma patients in order to better support them in managing their chronic disease.
Retrospectively registered with ClinicalTrials.gov (NCT03159247).
约一半的青光眼患者未坚持使用推荐药物。针对其他慢性病的干预措施已成功运用提醒系统和基于动机性访谈（MI）的咨询方法。本研究旨在试行一种个性化干预措施，利用这些策略来评估其对青光眼患者药物依从性的影响。
服用≥1种药物的青光眼患者将通过电话调查进行用药依从性预筛查。那些自我报告依从性差的患者将进入为期3个月的监测期，使用电子药物监测器测量药物依从性。在为期3个月的导入期内不依从（服用药物剂量≤80%）的参与者将有资格参加本研究。我们计划招募57名不依从用药的参与者。然后，将通过电子药物监测器、自我报告以及药房配药数据，在2年时间里持续测量参与者的依从性，在此期间将实施旨在提高药物依从性的两个资源投入依次增加的干预组成部分。第一个组成部分是为期3个月的提醒（音频和/或视觉），如果在预先设定的时间范围内未服药，则发送短信或自动拨打电话。第二个组成部分是由经过培训的青光眼咨询师开展的为期6个月的基于MI的咨询项目。该组成部分使用，这是一个基于计算机的个性化行为改变项目，使准专业人员能够为青光眼患者提供个性化教育和咨询。主要结局是药物依从性的变化。次要结局包括临床结局（眼压、IOP和IOP波动）的变化以及依从性的心理社会调节因素（如能力、改变的动力和满意度）。参与者将在12个月时接受半结构化访谈，以提供有关咨询项目的反馈，以便对其进行改进。
这项试点研究将深入了解如何为不依从的青光眼患者提供更个性化的医疗保健，以便更好地支持他们管理慢性病。
在ClinicalTrials.gov上进行回顾性注册（NCT03159247）。
