Improving African American Glaucoma Patient Involvement in Visits and Outcomes

Glaucoma Clinical Trial

Official title:

Improving African American Glaucoma Patient Involvement in Visits and Outcomes

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03657147
• Other study ID #: 17-0688
• Secondary ID: 1R01HS025370-01
• Status: Completed
• Phase: N/A
• Start date: September 10, 2018
• Est. completion date: August 12, 2022

Study information

• Verified date: June 2023
• Source: University of North Carolina, Chapel Hill
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This is a research project about services provided to African American patients with glaucoma. The goal of the project is to improve communication between providers and African-American patients about glaucoma.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 189
• Est. completion date: August 12, 2022
• Est. primary completion date: August 12, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• African American

• Age 18 or older

• Able to speak and read English

• Mentally competent to participate

• Not blind (are at least 20/400 in their better seeing eye)

• On one or more glaucoma medications

• Report being less than 80% adherent to their glaucoma medications on a Visual Analog Scale

Exclusion Criteria:

• < 18 years of age

Related Conditions & MeSH terms

• Glaucoma

Intervention

Behavioral:
• Educational Video and Question Prompt List
A short educational video will be presented on an iPad about the importance of encouraging patients to ask questions and to be involved during glaucoma visits to improve self-management skills. A question prompt list will also be completed where participants check questions of interest to ask the provider.

Locations

Country	Name	City	State
United States	University of North Carolina at Chapel Hill	Chapel Hill	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
University of North Carolina, Chapel Hill	Agency for Healthcare Research and Quality (AHRQ)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Intraocular Pressure	Intraocular pressure measurements will be extracted from each patient's medical record at the baseline, 6 month, and 12 month follow-up visits. For all time points, a mean intraocular pressure will be calculated by averaging the intraocular pressure across both eyes. Change in intraocular pressure over the 12 month period will then be assessed by calculating the difference in mean intraocular pressure.	12 months
Primary	Glaucoma Medication Percent Adherence	Medication adherence will be measured using the number of recorded doses from the Medication Event Monitoring System (MEMS) data, divided by the number of prescribed doses. Medication adherence can range from 0% to 100%.	12 months
Primary	Glaucoma Medication Adherence Self-Efficacy Score	Medication adherence self-efficacy is measured using a 21-item scale that has a reliability of 0.89. Scores can range from 21 to 63, and a higher score indicates a better outcome.	12 months