GlaucomaNCT02982629
Improving Access to Eye Care in Glaucoma Patients
A study testing Reminder letter Intervention in people with Glaucoma, run by Wills Eye.
Trial summary
1. To design and develop a prospective, randomized pilot study utilizing information from electronic medical records to address follow-up adherence and reduce the gap between recommended and actual follow-up adherence in patients with glaucoma. 2. Read more about this study
- Who is it for?
- Ages 21 years and olderHealthy volunteers can take part
- Conditions the study is for
- Glaucoma
- What is being tested?
- Reminder letter Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 250 participants
- Where
- No sites listed yet
- Study dates
- Mar 2013to Nov 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Attended Wills Eye Glaucoma Clinic from 9/1/12 and 10/31/13
Who cannot join
- Any medical condition that would preclude the subject from providing reliable and valid data.
- Recommended to f/u in less than 1 month time period.
About this study
Official title: Improving Access to Eye Care in Glaucoma Patients a Prospective, Controlled, Randomized Trial
- To design and develop a prospective, randomized pilot study utilizing information from electronic medical records to address follow-up adherence and reduce the gap between recommended and actual follow-up adherence in patients with glaucoma.
- To evaluate the impact of a telephone-based intervention on follow-up adherence in patients with glaucoma using a randomly assigned comparison with usual care.
Read the detailed description
The Wills Eye Health System (WEHS) proposes to conduct a pilot study to evaluate the feasibility and effectiveness of a telephone-based intervention to improve rates of follow-up exams in patients with glaucoma. The prospective, randomized, controlled trial entitled "Improving Access to Eye Care in Patients with Glaucoma" will utilize cohort data from 2013 electronic medical record information to reduce the gap between recommended and actual follow-up utilization of eye care services in glaucoma patients. Patients with glaucoma will be recruited from the Wills Eye Glaucoma clinic who were seen between 3/1/13 and 10/31/13. A recall list will be generated for patients who have scheduled follow-up appointments from 9/1/13 to 11/30/13. These patients will be randomly assigned to the "Usual Care" group or "Intervention" group. The primary outcome will be successful attendance at a follow-up appointment within an appropriate time frame. This intervention is based on a CDC funded project at Wills to improve access to eye care in patients with diabetes. Thus, this pilot study will test the efficacy of a telephone-based intervention to improve follow-up adherence in patients with glaucoma by improving access to eye care.
- Conditions
- Glaucoma
- Being tested
- Reminder letter Intervention
- Keywords
- Glaucoma, Eye Care, Community Outreach
- Medical subject headings
- Glaucoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Reminder letter InterventionBehavioural
Patients in this group receive letters and phone calls to reschedule missed follow-up appointments.
| Study group | Role | What they receive |
|---|---|---|
| Usual Care | Placebo comparator | Patients in this group do not receive any letters or phone calls after missing follow-up appointment. Receives: Behavioral: Reminder letter Intervention |
| Reminder Letter Intervention | Active comparator | Patients in this group receive letters and phone calls after missing follow-up appointment to reschedule the appointment. Receives: Behavioral: Reminder letter Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adherence to Follow-Up
Whether patients adhere to follow-up appointments at 28 weeks.
Measured: 28 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2016 (estimated)
- Study startMar 2013
- Primary completionNov 2013
- Study completionNov 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for GlaucomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 250 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wills Eye
- Sponsor type
- University, hospital or other
- Collaborators
- Thomas Jefferson University
- Responsible party
- Principal investigator, L. Jay Katz MD, Wills Eye
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02982629
- Sponsor's protocol ID
- 410005727
- Status last verified
- Dec 2023
- First submitted
- 6 Aug 2015
- Last updated
- 13 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes: A total of 8 papers have been published. Results will be uploaded by 2016.
Publications
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.
PubMed 27660423
Study at a glance
From the registry record, last updated by the sponsor on 13 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Access to Eye Care in Glaucoma Patients a Prospective, Controlled, Randomized Trial
- ClinicalTrials.gov ID
- NCT02982629
- Acronym / sponsor ID
- 410005727
- Conditions
- Glaucoma
- Keywords
- Glaucoma, Eye Care, Community Outreach
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 250 participants (actual)
- Lead sponsor
- Wills EyeUniversity, hospital or other
- Collaborators
- Thomas Jefferson University
- Study start
- Mar 2013
- Primary completion
- Nov 2013 (actual)
- Study completion
- Nov 2013 (actual)
- First posted
- 5 Dec 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
- To design and develop a prospective, randomized pilot study utilizing information from electronic medical records to address follow-up adherence and reduce the gap between recommended and actual follow-up adherence in patients with glaucoma.
- To evaluate the impact of a telephone-based intervention on follow-up adherence in patients with glaucoma using a randomly assigned comparison with usual care.
Detailed description
The Wills Eye Health System (WEHS) proposes to conduct a pilot study to evaluate the feasibility and effectiveness of a telephone-based intervention to improve rates of follow-up exams in patients with glaucoma. The prospective, randomized, controlled trial entitled "Improving Access to Eye Care in Patients with Glaucoma" will utilize cohort data from 2013 electronic medical record information to reduce the gap between recommended and actual follow-up utilization of eye care services in glaucoma patients. Patients with glaucoma will be recruited from the Wills Eye Glaucoma clinic who were seen between 3/1/13 and 10/31/13. A recall list will be generated for patients who have scheduled follow-up appointments from 9/1/13 to 11/30/13. These patients will be randomly assigned to the "Usual Care" group or "Intervention" group. The primary outcome will be successful attendance at a follow-up appointment within an appropriate time frame. This intervention is based on a CDC funded project at Wills to improve access to eye care in patients with diabetes. Thus, this pilot study will test the efficacy of a telephone-based intervention to improve follow-up adherence in patients with glaucoma by improving access to eye care.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Usual Care | Placebo comparator | Behavioral: Reminder letter InterventionPatients in this group do not receive any letters or phone calls after missing follow-up appointment. |
| Reminder Letter Intervention | Active comparator | Behavioral: Reminder letter InterventionPatients in this group receive letters and phone calls after missing follow-up appointment to reschedule the appointment. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Attended Wills Eye Glaucoma Clinic from 9/1/12 and 10/31/13
Key exclusion criteria (2 listed)
- Any medical condition that would preclude the subject from providing reliable and valid data.
- Recommended to f/u in less than 1 month time period.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Reminder letter InterventionPatients in this group receive letters and phone calls to reschedule missed follow-up appointments. | Behavioural | Reminder Letter Intervention, Usual Care |
Primary outcome
Adherence to Follow-Up
Time frame: 28 weeks
Whether patients adhere to follow-up appointments at 28 weeks.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Dec 2023.
- Background: PubMed 27660423Hark 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.
- Individual participant dataSharing planned: Yes. A total of 8 papers have been published. Results will be uploaded by 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Reminder letter Intervention in people with Glaucoma, run by Wills Eye.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adherence to Follow-Up (time frame: 28 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02982629, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Dec 2023; AzTrials last refreshed its copy on 5 Nov 2026.