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临床试验/CTRI/2024/09/073433
CTRI/2024/09/073433尚未招募不适用

Assessment of the role of regular text messages, audio-visual reminders using adherence monitors, and one on one counselling on the adherence to topical medications in patients with glaucoma - A non-randomized study

W K Kellogg Eye Centre, Michigan1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2024年9月23日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
100
试验地点
1
主要终点
1. To assess the change in mean adherence from baseline following regular text messages, audio-visual reminders using adherence monitors and counselling

研究概览

简要总结

High rates of poor adherence to effective medications is a key modifiable barrier to better outcomes for people with glaucoma. Various methods to modify the adherence that have been described in literature including patient education interventions, counselling, personalized glaucoma coaching programs, giving written instructions, reminder systems, rescheduling of eye drop therapy with simplification of dosing, eye drop instillation training, creation of a glaucoma club among others.

Through this study, we aim to assess the benefit of regular text messages, audio-visual reminders using adherence monitors and counselling on the adherence to topical medications in patients with glaucoma in a south Indian population.

We hypothesize that the adherence to topical anti-glaucoma medications would improve by providing reminders or intensive counselling sessions to the participants. A reminder text message service if found beneficial, may also be provided by subscription to the patients in the future.

研究设计

研究类型
Interventional
分配方式
Na
盲法
None

入排标准

年龄范围
18.00 Year(s) 至 80.00 Year(s)(—)
性别
All

入选标准

  • 未提供

排除标准

  • Newly diagnosed patients with glaucoma
  • Glaucoma patients with uncontrolled IOP
  • Glaucoma patients who are not on stable medications
  • Ocular hypertension (OHT)
  • Normal tension glaucoma
  • Secondary glaucomas like immediate post-surgical, steroid induced which might not need long term anti-glaucoma medications
  • History of intraocular surgery within the previous 3 months
  • People with cognitive decline – BCVA in the better eye less than 6/60, poor hearing requiring hearing aids
  • Illiterate patients
  • Pregnant / nursing mothers.

结局指标

主要结局

1. To assess the change in mean adherence from baseline following regular text messages, audio-visual reminders using adherence monitors and counselling

时间窗: 6 months

2. To assess the proportion of participants with improved adherence from baseline following regular text messages, audio-visual reminders using adherence monitors and counselling

时间窗: 6 months

次要结局

  • 1. To assess the barriers for adherence based on a survey questionnaire(2. To assess the participant feedback regarding the three methods of intervention - regular text messages, audio-visual reminders using adherence monitors and counselling using a feedback form)

研究者

发起方
W K Kellogg Eye Centre, Michigan
申办方类型
Research institution and hospital
责任方
Principal Investigator
主要研究者

Swati Upadhyaya

Aravind Eye Hospital, Pondicherry

研究点 (1)

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