Sharp Health Companion App for Cataract Surgery Preparation and Recovery

Sharp HealthCare

Status: Completed

Conditions: Cataract

Treatments: Behavioral: Printed Instructions with Phone Reminders; Behavioral: Sharp Health Companion App (CareKit)

Study type: Interventional

Funder types: Other

Identifiers

NCT07028359

SHARP-CAT-RCT2022

Details and patient eligibility

About

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).

Full description

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).

Enrollment: 200 patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion criteria

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)

Exclusion criteria

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)

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

200 participants in 2 patient groups

Group 1: Printed Instructions + Phone Reminders

Active Comparator group

Description:

Participants in this arm received printed instructions for cataract surgery preparation and recovery, along with automated phone reminders. They used a printed checklist to track medication adherence. This group did not receive the Sharp Health Companion App.

Treatment:

Behavioral: Printed Instructions with Phone Reminders

Group 2: Sharp Health Companion Mobile App Group

Experimental group

Description:

Participants in this arm used the Sharp Health Companion App, a CareKit-based iPhone application, to receive digital pre- and postoperative instructions, medication reminders, and educational content. The app tracked medication adherence and surgical prep. Printed instructions were provided as backup.

Treatment:

Behavioral: Sharp Health Companion App (CareKit)