CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 200 enrolled
Drug / intervention
Printed Instructions with Phone Reminders +1 morebehavioral
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT07028359
NCT07028359N/ACompleted

Sharp Health Companion App for Perioperative Education and Monitoring of Cataract Eye Surgery Patients Using CareKit Health Platform

Sharp HealthCare·interventional·Posted Jun 19, 2025·Updated Jun 19, 2025

In Brief

A clinical study evaluating Printed Instructions with Phone Reminders and Sharp Health Companion App (CareKit) for Cataract. Completed, enrolled 200 participants across 1 site.

Detailed Summary

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).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCataract
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
2023202420252026
First PostedJun 19, 2025
Enrollment StartDec 1, 2022
Primary CompletionFeb 28, 2024
Study CompletionSep 30, 2024
TodayJul 2, 2026
Enrollment to primary: 1.2 yearsPosted 1.0 years ago

Interventions

Printed Instructions with Phone Remindersbehavioral

Participants received paper-based instructions for perioperative care, including medication, fasting, and follow-up logistics. Automated phone calls were sent before surgery to reinforce preparation. Participants used a printed checklist to self-report eye drop adherence.

Sharp Health Companion App (CareKit)behavioral

The Sharp Health Companion App delivered interactive digital perioperative checklists, medication adherence prompts, COVID-19 protocol reminders, symptom tracking, and educational videos via iPhone. Participants logged their medication use in real time on the Sharp Health Companion App. Printed instructions were provided as a backup.