Ignite Creation Date:
2025-12-24 @ 2:55 PM
Ignite Modification Date:
2025-12-27 @ 8:36 PM
Study NCT ID:
NCT07028359
Status:
COMPLETED
Last Update Posted:
2025-06-19
First Post:
2025-06-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Sharp Health Companion App for Cataract Surgery Preparation and Recovery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002386', 'term': 'Cataract'}, {'id': 'D055118', 'term': 'Medication Adherence'}], 'ancestors': [{'id': 'D007905', 'term': 'Lens Diseases'}, {'id': 'D005128', 'term': 'Eye Diseases'}, {'id': 'D010349', 'term': 'Patient Compliance'}, {'id': 'D010342', 'term': 'Patient Acceptance of Health Care'}, {'id': 'D000074822', 'term': 'Treatment Adherence and Compliance'}, {'id': 'D015438', 'term': 'Health Behavior'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'Group assignments were concealed from investigators, care teams, and outcomes assessors using a digital randomization app and unique study identifiers.'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL', 'interventionModelDescription': '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'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 200}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-12-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-06', 'completionDateStruct': {'date': '2024-09-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-06-11', 'studyFirstSubmitDate': '2025-06-11', 'studyFirstSubmitQcDate': '2025-06-11', 'lastUpdatePostDateStruct': {'date': '2025-06-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-06-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-02-28', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Objective Medication Adherence Rate', 'timeFrame': '30 days post-surgery', 'description': '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).'}, {'measure': 'Same-Day Cataract Surgery Delay Rate', 'timeFrame': 'Day of Surgery', 'description': '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).'}, {'measure': 'Cataract Surgery Cancellation Rate', 'timeFrame': 'Day of schedule surgery', 'description': '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).'}], 'secondaryOutcomes': [{'measure': 'Self-Reported Medication Adherence', 'timeFrame': '30 days post-surgery', 'description': '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).'}, {'measure': 'Visual Acuity Outcome', 'timeFrame': 'Baseline to 30 days post-surgery', 'description': '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).'}, {'measure': 'Patient Reported Surgical Experience Score', 'timeFrame': '30 days post-surgery', 'description': '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).'}, {'measure': 'Postoperative custodial macular edema (CME) incidence', 'timeFrame': '30 days post-surgery', 'description': '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).'}, {'measure': 'Postoperative Iritis Incidence', 'timeFrame': '30 days post-surgery', 'description': '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).'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Cataract surgery', 'Mobile Health', 'Mhealth', 'Digital health', 'Medication adherence', 'Perioperative care', 'Older adults', 'Sharp health companion app', 'CareKit', 'iPhone'], 'conditions': ['Cataract']}, 'descriptionModule': {'briefSummary': "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).", 'detailedDescription': "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)."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nScheduled 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)\n\nExclusion Criteria:\n\nHistory 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)'}, 'identificationModule': {'nctId': 'NCT07028359', 'briefTitle': 'Sharp Health Companion App for Cataract Surgery Preparation and Recovery', 'organization': {'class': 'OTHER', 'fullName': 'Sharp HealthCare'}, 'officialTitle': 'Sharp Health Companion App for Perioperative Education and Monitoring of Cataract Eye Surgery Patients Using CareKit Health Platform', 'orgStudyIdInfo': {'id': 'SHARP-CAT-RCT2022'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Group 1: Printed Instructions + Phone Reminders', '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.', 'interventionNames': ['Behavioral: Printed Instructions with Phone Reminders']}, {'type': 'EXPERIMENTAL', 'label': 'Group 2: Sharp Health Companion Mobile App 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.', 'interventionNames': ['Behavioral: Sharp Health Companion App (CareKit)']}], 'interventions': [{'name': 'Printed Instructions with Phone Reminders', 'type': 'BEHAVIORAL', 'description': '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.', 'armGroupLabels': ['Group 1: Printed Instructions + Phone Reminders']}, {'name': 'Sharp Health Companion App (CareKit)', 'type': 'BEHAVIORAL', 'description': '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.', 'armGroupLabels': ['Group 2: Sharp Health Companion Mobile App Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '92123', 'city': 'San Diego', 'state': 'California', 'country': 'United States', 'facility': 'Sharp Rees-Stealy Medical Group', 'geoPoint': {'lat': 32.71571, 'lon': -117.16472}}], 'overallOfficials': [{'name': 'Tommy Korn, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Sharp Rees-Stealy Medical Group and Sharp HealthCare'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sharp HealthCare', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}