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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).
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1: Printed Instructions + Phone Reminders | Active Comparator | 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. |
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| Group 2: Sharp Health Companion Mobile App Group | Experimental | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Printed Instructions with Phone Reminders | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Objective Medication Adherence Rate | 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). | 30 days post-surgery |
| Same-Day Cataract Surgery Delay Rate | 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). | Day of Surgery |
| Cataract Surgery Cancellation Rate | 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). | Day of schedule surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Self-Reported Medication Adherence | 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). | 30 days post-surgery |
| Visual Acuity Outcome |
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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)
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| Name | Affiliation | Role |
|---|---|---|
| Tommy Korn, MD | Sharp Rees-Stealy Medical Group and Sharp HealthCare | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sharp Rees-Stealy Medical Group | San Diego | California | 92123 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 42055536 | Derived | Korn TS, Assissini A, Slater LA, Holland J, Doone L, Lam E, Fox J, Greenwood KL, Linebarger E. Digital Health Support for Cataract Surgery With the Sharp Health Companion CareKit App: Randomized Controlled Trial. JMIR Mhealth Uhealth. 2026 Apr 29;14:e78710. doi: 10.2196/78710. |
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| ID | Term |
|---|---|
| D002386 | Cataract |
| D055118 | Medication Adherence |
| ID | Term |
|---|---|
| D007905 | Lens Diseases |
| D005128 | Eye Diseases |
| D010349 | Patient Compliance |
| D010342 | Patient Acceptance of Health Care |
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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
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Group assignments were concealed from investigators, care teams, and outcomes assessors using a digital randomization app and unique study identifiers.
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| 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. |
|
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). |
| Baseline to 30 days post-surgery |
| Patient Reported Surgical Experience Score | 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). | 30 days post-surgery |
| Postoperative custodial macular edema (CME) incidence | 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). | 30 days post-surgery |
| Postoperative Iritis Incidence | 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). | 30 days post-surgery |
| D000074822 |
| Treatment Adherence and Compliance |
| D015438 | Health Behavior |
| D001519 | Behavior |