Comparison Study of Glaucoma Eye Care Follow-Up Adherence in a High Risk Population
NCT ID: NCT02347670
Last Updated: 2023-12-13
Study Results
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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COMPLETED
NA
155 participants
INTERVENTIONAL
2014-08-31
2015-12-31
Brief Summary
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Detailed Description
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There are approximately 700 potentially eligible persons from the 39 community sites, and of that the investigators hope to enroll 250 into 1 of four groups. Eligible participants have participated in the community-based comprehensive eye examination, have received a diagnosis of glaucoma-suspect or any type of glaucoma, including open angle glaucoma, chronic angle closure glaucoma, ocular hypertension, anatomically narrow-angle, pigmentary glaucoma, low tension glaucoma, or pseudoexfoliative glaucoma (identified using International Classification of Diseases (ICD)-9 codes), are recommended for follow-up care and have attended their Center for Disease Control and Prevention 6-month follow-up visit, are willing and able to give informed consent and participate for 1 year, any have undergone laser therapy. Excluded subjects are unwilling to attend randomized site for follow-up visits or prefers to continue follow-up eye care with their personal ophthalmologists.
Over the course of 1 year, a 6-person team comprised of one attending physician; project managers and community health educations, ophthalmic technician, and patient navigators will complete a baseline visit, baseline assessment and 2-3 follow-up visits in community and office-based locations. A leased Wills Eye van will transport the intervention team and all necessary equipment to the site. The equipment will occupy a designated location at each site for 1 to 2 days per month, from 9 a.m. to 3 p.m., with at least 15 eye examinations performed each day. The same team will see participants who are randomized to the Wills Eye Glaucoma Research Center location.
Participants randomized to receiving help in patient navigation protocol at the community and office-based locations will receive more individualized care than others such as assistance with scheduling; a confirmation letter, text or email; a personal phone call the day before the appointment; and assistance with rescheduling appointments as needed and will consistently arrange transportation to appointments as needed, provide materials, and accompany study participants to their follow-up appointments at Wills Eye. Patient navigators, ocular technicians, and physicians will also communicate with family members regarding recommended follow-up visits, medication refills, and laser-therapy recommendations, as needed.
Participants randomized to usual care protocol at the office-based location will receive a phone number to call and schedule an appointment. Prior to the follow-up visit, participants in the usual-care group who have scheduled an appointment will receive an automated phone call similar to the standard appointment-reminding procedure commonly used at the Wills Eye Hospital. If participants do not show-up for their appointment that will be documented. Participants in the usual-care group will receive any necessary interpretation services, educational materials, and referrals to cataract surgery or other eye-care services, as needed. The intervention team will assure that participants with literacy issues can understand all information. This group is a realistic choice currently available for patients and thus will be used to compare with the patient navigator protocol.
Conditions
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Study Design
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RANDOMIZED
SINGLE_GROUP
HEALTH_SERVICES_RESEARCH
NONE
Study Groups
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Group 1M- Community Site
Participants randomized to Group 1-Main will attend follow-up visits at one of the four main community sites. A glaucoma specialist will perform the comprehensive eye examination and a ophthalmic technician will conduct the testing. There will be no charge or co-pay for these visits. Group 1 participants will test the efficacy of the patient navigator to improve follow-up adherence. During the first and final follow-up visit, those enrolled will undergo the National Eye Institute-Visual Function Questionnaire-25 and the Geriatric Depression Scale-15 and Research Participation Questionnaire.
Intervention: Efficacy-patient navigator to improve follow-up adherence
Efficacy-patient navigator to improve follow-up adherence
Over the course of 1 year, a 6-person team comprised of one attending physician ; ophthalmic technicians, project managers/community health educators , and patient navigators will complete a baseline eye examination visit, baseline assessment, and 2-3 follow-up visits. The equipment will occupy a designated location at each site for 1 to 2 days, from 9 a.m. to 3 p.m., with at least 15 eye examinations performed each day. With assistance from the patient navigator, participants will receive assistance with scheduling appointments, arranging transportation, reminder letters, and referral s for ocular care.
Group 2- Office-Based
Office-Based, Follow-Up Eye Care with Patient Navigation Protocol: Participants randomized to Group 2 will attend follow-up visits at the Wills Eye Hospital Glaucoma Research Center. A glaucoma specialist will perform the eye examination. Ophthalmic technicians will conduct the testing. There will be no charge or co-pay for these visits. Group 1 participants will test the efficacy of the patient navigator to improve follow-up adherence. During the first and final follow-up visit, those enrolled will undergo the National Eye Institute-Visual Function Questionnaire-25 and the Geriatric Depression Scale-15 and Research Participation Questionnaire.
Intervention: Efficacy-patient navigator to improve follow-up adherence
Efficacy-patient navigator to improve follow-up adherence
Over the course of 1 year, a 6-person team comprised of one attending physician ; ophthalmic technicians, project managers/community health educators , and patient navigators will complete a baseline eye examination visit, baseline assessment, and 2-3 follow-up visits. The equipment will occupy a designated location at each site for 1 to 2 days, from 9 a.m. to 3 p.m., with at least 15 eye examinations performed each day. With assistance from the patient navigator, participants will receive assistance with scheduling appointments, arranging transportation, reminder letters, and referral s for ocular care.
Group 3- Office-Based
Group 3- follow-up eye care at the Wills Eye Hospital. There will be no charge or co-pay for these visits. Those enrolled will undergo the National Eye Institute-Visual Function Questionnaire-25 and the Geriatric Depression Scale-15 and Research Participation Questionnaire. These participants will receive a phone number to call and schedule their appointment and will receive a reminder phone call similar to the standard appointment-reminding procedure commonly used at the Wills Eye Hospital. Group 3 represents a realistic choice currently available for patients and thus will be used to compare with usual care and will have 2-3 visits over the one-year period depending on diagnosis.
Intervention: Office-Based Usual Care
Office-Based Usual Care
Over the course of 1 year, a 6-person team comprised of one attending physician ; ophthalmic technicians, project managers/community health educators , and patient navigators will complete a baseline eye examination visit, baseline assessment, and 2-3 follow-up visits. The equipment will occupy a designated location at each site for 1 to 2 days, from 9 a.m. to 3 p.m., with at least 15 eye examinations performed each day.
This intervention group will receive a phone number to schedule an appointment. Participants in the usual-care group who have scheduled an appointment will receive an automated phone call similar to the standard appointment-reminding procedure used at the Wills Eye Hospital.
Group 1R- Community Site
Participants randomized to Group 1-Randomized will attend follow-up visits at one of the four main community sites, these participants were randomized from the 40 community sites to the closest community location. A glaucoma specialist will perform the comprehensive eye examination. Ophthalmic technicians will conduct the testing. There will be no charge or co-pay for these visits. Group 1 participants will test the efficacy of the patient navigator to improve follow-up adherence. During the first and final follow-up visit, those enrolled will undergo the National Eye Institute-Visual Function Questionnaire-25 and the Geriatric Depression Scale-15 and Research Participation Questionnaire.
Intervention: Efficacy-patient navigator to improve follow-up adherence
Efficacy-patient navigator to improve follow-up adherence
Over the course of 1 year, a 6-person team comprised of one attending physician ; ophthalmic technicians, project managers/community health educators , and patient navigators will complete a baseline eye examination visit, baseline assessment, and 2-3 follow-up visits. The equipment will occupy a designated location at each site for 1 to 2 days, from 9 a.m. to 3 p.m., with at least 15 eye examinations performed each day. With assistance from the patient navigator, participants will receive assistance with scheduling appointments, arranging transportation, reminder letters, and referral s for ocular care.
Interventions
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Efficacy-patient navigator to improve follow-up adherence
Over the course of 1 year, a 6-person team comprised of one attending physician ; ophthalmic technicians, project managers/community health educators , and patient navigators will complete a baseline eye examination visit, baseline assessment, and 2-3 follow-up visits. The equipment will occupy a designated location at each site for 1 to 2 days, from 9 a.m. to 3 p.m., with at least 15 eye examinations performed each day. With assistance from the patient navigator, participants will receive assistance with scheduling appointments, arranging transportation, reminder letters, and referral s for ocular care.
Office-Based Usual Care
Over the course of 1 year, a 6-person team comprised of one attending physician ; ophthalmic technicians, project managers/community health educators , and patient navigators will complete a baseline eye examination visit, baseline assessment, and 2-3 follow-up visits. The equipment will occupy a designated location at each site for 1 to 2 days, from 9 a.m. to 3 p.m., with at least 15 eye examinations performed each day.
This intervention group will receive a phone number to schedule an appointment. Participants in the usual-care group who have scheduled an appointment will receive an automated phone call similar to the standard appointment-reminding procedure used at the Wills Eye Hospital.
Eligibility Criteria
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Inclusion Criteria
* Have a diagnosis of glaucoma-suspect or any type of glaucoma, including open angle glaucoma, chronic angle closure glaucoma, ocular hypertension, anatomically narrow-angle, pigmentary glaucoma, low tension glaucoma, or pseudoexfoliative glaucoma (identified using ICD-9 codes).
* Are recommended for follow-up care.
* Are willing and able to give informed consent and participate for 1 year.
* May have undergone laser therapy.
Exclusion Criteria
* Requested to follow-up only with their own ophthalmologist for their glaucoma eye-care.
50 Years
ALL
No
Sponsors
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Partridge Foundation
UNKNOWN
Wills Eye
OTHER
Responsible Party
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Principal Investigators
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L. J. Katz, MD
Role: PRINCIPAL_INVESTIGATOR
Wills Eye Hospital
Locations
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Wills Eye Hospital
Philadelphia, Pennsylvania, United States
Countries
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References
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Hark LA, Johnson DM, Berardi G, Patel NS, Zeng L, Dai Y, Mayro EL, Waisbourd M, Katz LJ. A randomized, controlled trial to test the effectiveness of a glaucoma patient navigator to improve appointment adherence. Patient Prefer Adherence. 2016 Sep 8;10:1739-48. doi: 10.2147/PPA.S108391. eCollection 2016.
Other Identifiers
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IRB#14-380
Identifier Type: -
Identifier Source: org_study_id