Sharp Health Companion App for Perioperative Education and Monitoring of Cataract Eye Surgery Patients Using CareKit Health Platform
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 200
- 试验地点
- 2
- 主要终点
- Objective Medication Adherence Rate
研究概览
简要总结
This randomized controlled trial evaluated the effectiveness of the Sharp Health Companion App, a smartphone-based digital health tool, compared to standard printed instructions for supporting older adults undergoing cataract surgery. The study enrolled 200 patients aged 39-86 from a high-volume ophthalmology practice. Participants were randomly assigned to either a printed instructions group or a group using the mobile app built on Apple's CareKit platform. Outcomes included surgery cancellation rates, day-of-surgery delays, medication adherence (both subjective and objective), visual acuity, and patient satisfaction. The app significantly reduced same-day surgery delays and improved objective medication adherence. The study was completed between December 2022 and January 2024 and was approved by the Sharp HealthCare Institutional Review Board (IRB #2209803).
详细描述
This randomized controlled trial evaluated the effectiveness of the Sharp Health Companion App, a smartphone-based digital health tool, compared to standard printed instructions for supporting older adults undergoing cataract surgery. The study enrolled 200 patients aged 39-86 from a high-volume ophthalmology practice. Participants were randomly assigned to either a printed instructions group or a group using the mobile app built on Apple's open source CareKit platform. Outcomes included surgery cancellation rates, day-of-surgery delays, medication adherence (both subjective and objective), visual acuity, and patient satisfaction. The app significantly reduced same-day surgery delays and improved objective medication adherence. The study was completed between December 2022 and January 2024 and was approved by the Sharp HealthCare Institutional Review Board (IRB #2209803).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Group assignments were concealed from investigators, care teams, and outcomes assessors using a digital randomization app and unique study identifiers.
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Scheduled for first-time cataract surgery at Sharp HealthCare Best-corrected visual acuity of 20/40 or worse Able to provide informed consent English-speaking For Group 2: possession of an iPhone and ability to use smartphone functions (e.g., Face ID or passcode)
排除标准
- •History of prior cataract surgery Significant cognitive, visual, or physical impairment preventing use of the app Inability to follow study procedures or complete follow-up Lack of access to compatible technology (Group 2 only)
结局指标
主要结局
Objective Medication Adherence Rate
时间窗: 30 days post-surgery
Percentage of patients whose surgery was delayed by two or more hours on the day of surgery due to noncompliance with preparation protocols (e.g., dietary, arrival time, or documentation errors).
Same-Day Cataract Surgery Delay Rate
时间窗: Day of Surgery
Percentage of patients whose surgery was delayed by two or more hours on the day of surgery due to noncompliance with preparation protocols (e.g., dietary, arrival time, or documentation errors).
Cataract Surgery Cancellation Rate
时间窗: Day of schedule surgery
Percentage of patients whose surgery was delayed by two or more hours on the day of surgery due to noncompliance with preparation protocols (e.g., dietary, arrival time, or documentation errors).
次要结局
- Self-Reported Medication Adherence(30 days post-surgery)
- Visual Acuity Outcome(Baseline to 30 days post-surgery)
- Patient Reported Surgical Experience Score(30 days post-surgery)
- Postoperative custodial macular edema (CME) incidence(30 days post-surgery)
- Postoperative Iritis Incidence(30 days post-surgery)