Back to resultsImproving African American Glaucoma Patient Involvement in Visits and Outcomes
Primary Purpose
Glaucoma
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Educational Video and Question Prompt List
Sponsored by
About this trial
This is an interventional health services research trial for Glaucoma
Eligibility Criteria
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
Sites / Locations
- University of North Carolina at Chapel Hill
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Question Prompt List and Video
Usual Care
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
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.
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%.
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT03657147
First Posted
August 28, 2018
Last Updated
June 27, 2023
Sponsor
University of North Carolina, Chapel Hill
Collaborators
Agency for Healthcare Research and Quality (AHRQ)
1. Study Identification
Unique Protocol Identification Number
NCT03657147
Brief Title
Improving African American Glaucoma Patient Involvement in Visits and Outcomes
Official Title
Improving African American Glaucoma Patient Involvement in Visits and Outcomes
Study Type
Interventional
2. Study Status
Record Verification Date
June 2023
Overall Recruitment Status
Completed
Study Start Date
September 10, 2018 (Actual)
Primary Completion Date
August 12, 2022 (Actual)
Study Completion Date
August 12, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of North Carolina, Chapel Hill
Collaborators
Agency for Healthcare Research and Quality (AHRQ)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Glaucoma
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
189 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Question Prompt List and Video
Arm Type
Experimental
Arm Description
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.
Arm Title
Usual Care
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Educational Video and Question Prompt List
Intervention Description
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.
Primary Outcome Measure Information:
Title
Intraocular Pressure
Description
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.
Time Frame
12 months
Title
Glaucoma Medication Percent Adherence
Description
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%.
Time Frame
12 months
Title
Glaucoma Medication Adherence Self-Efficacy Score
Description
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.
Time Frame
12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Betsy Sleath, PhD
Organizational Affiliation
University of North Carolina, Chapel Hill
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of North Carolina at Chapel Hill
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27599
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Improving African American Glaucoma Patient Involvement in Visits and Outcomes
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