Improving African American Glaucoma Patient Involvement in Visits and Outcomes

Not Applicable

Completed

• Conditions: Glaucoma
• Interventions: Behavioral: Educational Video and Question Prompt List

• Registration Number: NCT03657147
• Lead Sponsor: University of North Carolina, Chapel Hill

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-08-28
• Study First Submitted QC: 2018-08-28
• Study First Posted: 2018-09-04
• Study Start: 2018-09-10
• Primary Completion: 2022-08-12
• Study Completion: 2022-08-12
• Status Verified: 2023-06
• Last Update Submitted: 2023-06-27
• Last Update Posted: 2023-06-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 189

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

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Exclusion Criteria

• < 18 years of age

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Question Prompt List and Video	Educational Video and Question Prompt List	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.

Primary Outcome Measures

Name	Time	Method
Intraocular Pressure	12 months	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.
Glaucoma Medication Percent Adherence	12 months	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%.
Glaucoma Medication Adherence Self-Efficacy Score	12 months	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.

Trial Locations

Locations (1)

University of North Carolina at Chapel Hill; 🇺🇸 Chapel Hill, North Carolina, United States