Cataract
Conditions
Keywords
Cataract surgery, Mobile Health, Mhealth, Digital health, Medication adherence, Perioperative care, Older adults, Sharp health companion app, CareKit, iPhone
Brief 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).
Detailed 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).
Interventions
BEHAVIORALPrinted 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.
BEHAVIORALSharp 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.
Sponsors
Sharp HealthCare
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
Group assignments were concealed from investigators, care teams, and outcomes assessors using a digital randomization app and unique study identifiers.
Intervention model description
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
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Objective Medication Adherence Rate | 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 | 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 | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Postoperative custodial macular edema (CME) incidence | 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). |
| Self-Reported Medication Adherence | 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). |
| Postoperative Iritis Incidence | 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). |
| Visual Acuity Outcome | Baseline to 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). |
| Patient Reported Surgical Experience Score | 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). |
Countries
United States
Outcome results
None listed