Sharp Health Companion App for Cataract Surgery Preparation and Recovery

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-12-01

Study Completion Date

2024-09-30

Brief Summary

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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).

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Detailed Description

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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).

Conditions

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Cataract

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Participants were randomly assigned 1:1 to printed instructions with phone reminders (Group 1) or to the Sharp Health Companion mobile app (Group 2), built using CareKit platform

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Group assignments were concealed from investigators, care teams, and outcomes assessors using a digital randomization app and unique study identifiers.

Study Groups

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Group 1: Printed Instructions + Phone Reminders

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.

Group Type ACTIVE_COMPARATOR

Printed Instructions with Phone Reminders

Intervention Type BEHAVIORAL

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.

Group 2: Sharp Health Companion Mobile App Group

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.

Group Type EXPERIMENTAL

Sharp Health Companion App (CareKit)

Intervention Type 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.

Interventions

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Printed Instructions with Phone Reminders

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.

Intervention Type BEHAVIORAL

Sharp Health Companion App (CareKit)

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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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)

Eligible Sex

ALL

Accepts Healthy Volunteers

No