NCT02982629

Brief Summary

  1. 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. 2.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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
250

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2013

Shorter than P25 for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2013

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2013

Completed
1.8 years until next milestone

First Submitted

Initial submission to the registry

August 6, 2015

Completed
1.3 years until next milestone

First Posted

Study publicly available on registry

December 5, 2016

Completed
Last Updated

December 13, 2023

Status Verified

December 1, 2023

Enrollment Period

8 months

First QC Date

August 6, 2015

Last Update Submit

December 6, 2023

Conditions

Keywords

GlaucomaEye CareCommunity Outreach

Outcome Measures

Primary Outcomes (1)

  • Adherence to Follow-Up

    Whether patients adhere to follow-up appointments at 28 weeks.

    28 weeks

Study Arms (2)

Usual Care

PLACEBO COMPARATOR

Patients in this group do not receive any letters or phone calls after missing follow-up appointment.

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.

Behavioral: Reminder letter Intervention

Interventions

Patients in this group receive letters and phone calls to reschedule missed follow-up appointments.

Reminder Letter InterventionUsual Care

Eligibility Criteria

Age21 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Attended Wills Eye Glaucoma Clinic from 9/1/12 and 10/31/13

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • 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.

    PMID: 27660423BACKGROUND

MeSH Terms

Conditions

Glaucoma

Condition Hierarchy (Ancestors)

Ocular HypertensionEye Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

August 6, 2015

First Posted

December 5, 2016

Study Start

March 1, 2013

Primary Completion

November 1, 2013

Study Completion

November 1, 2013

Last Updated

December 13, 2023

Record last verified: 2023-12

Data Sharing

IPD Sharing
Will share

A total of 8 papers have been published. Results will be uploaded by 2016.