Improving African American Glaucoma Patient Involvement in Visits and Outcomes

• Sponsor: University of North Carolina, Chapel Hill (Other)
• Overall Status: Active, not recruiting
• CT.gov ID: NCT03657147
• Collaborator: Agency for Healthcare Research and Quality (AHRQ) (U.S. Fed)
• Enrollment: 380
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 50.7
• Patients Per Site Per Month: 7.5

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Glaucoma	Behavioral: Educational Video and Question Prompt List	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 380 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Health Services Research
• Official Title: Improving African American Glaucoma Patient Involvement in Visits and Outcomes
• Actual Study Start Date: Sep 10, 2018
• Anticipated Primary Completion Date: Dec 1, 2022
• Anticipated Study Completion Date: Dec 1, 2022

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

1. 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.

2. 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%.

3. 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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of North Carolina at Chapel Hill	Chapel Hill	North Carolina	United States	27599

Sponsors and Collaborators

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

Investigators

• Principal Investigator: Betsy Sleath, PhD, University of North Carolina, Chapel Hill

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: University of North Carolina, Chapel Hill
• ClinicalTrials.gov Identifier: NCT03657147
• Other Study ID Numbers: 17-0688; 1R01HS025370-01
• First Posted: Sep 4, 2018
• Last Update Posted: May 6, 2022
• Last Verified: May 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Glaucoma

Study Results

No Results Posted as of May 6, 2022