Improving African American Glaucoma Patient Involvement in Visits and Outcomes

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.

Study Overview

• Status: Completed
• Conditions: Glaucoma
• Intervention / Treatment: Behavioral: Educational Video and Question Prompt List

• Study Type: Interventional
• Enrollment (Actual): 189
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Chapel Hill, North Carolina, United States, 27599
      • University of North Carolina at Chapel Hill

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Question Prompt List and Video; Participants will watch an educational video and question prompt list will be provided. Glaucoma visits will be audio-taped. A 15-20-minute interview will be conducted after the visit by a research assistant.	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.
No Intervention: Usual Care; The usual care group will not receive any intervention. Glaucoma visits will be audio-taped. A 15-20-minute interview will be conducted after the visit by a research assistant.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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

Collaborators and Investigators

• Sponsor: University of North Carolina, Chapel Hill
• Collaborators: Agency for Healthcare Research and Quality (AHRQ)
• Investigators: Principal Investigator: Betsy Sleath, PhD, University of North Carolina, Chapel Hill

Study record dates

Study Major Dates

• Study Start (Actual): September 10, 2018
• Primary Completion (Actual): August 12, 2022
• Study Completion (Actual): August 12, 2022

Study Registration Dates

• First Submitted: August 28, 2018
• First Submitted That Met QC Criteria: August 28, 2018
• First Posted (Actual): September 4, 2018

Study Record Updates

• Last Update Posted (Actual): June 29, 2023
• Last Update Submitted That Met QC Criteria: June 27, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Ocular Hypertension; Glaucoma
• Other Study ID Numbers: 17-0688; 1R01HS025370-01 (U.S. AHRQ Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No