GlaucomaNCT03657147
Improving African American Glaucoma Patient Involvement in Visits and Outcomes
A study testing Educational Video and Question Prompt List in people with Glaucoma, run by University of North Carolina, Chapel Hill at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Glaucoma
- What is being tested?
- Educational Video and Question Prompt List
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 189 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Sep 2018to 12 Aug 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- < 18 years of age
Trial locations and contacts
1 site in 1 country.
United States1 site
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, 27599
About this study
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.
- Conditions
- Glaucoma
- Being tested
- Educational Video and Question Prompt List
- Medical subject headings
- Glaucoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Educational Video and Question Prompt ListBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Question Prompt List and Video | Experimental | 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. Receives: Behavioral: Educational Video and Question Prompt List |
| Usual Care | No intervention | 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 being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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%.
Measured: 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.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Sep 2018
- Study start10 Sep 2018
- Primary completion12 Aug 2022
- Study completion12 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for GlaucomaStudies of the same condition, open and under way.
- More trials run by University of North Carolina, Chapel HillThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 189 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of North Carolina, Chapel Hill
- Sponsor type
- University, hospital or other
- Collaborators
- Agency for Healthcare Research and Quality (AHRQ)
- Responsible party
- Sponsor
- Investigators
- Betsy Sleath, PhD, Principal investigator, University of North Carolina, Chapel Hill
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03657147
- Sponsor's protocol ID
- 17-0688
- Other IDs
- 1R01HS025370-01
- Status last verified
- Jun 2023
- First submitted
- 28 Aug 2018
- Last updated
- 29 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Sleath B, Carpenter DM, Budenz DL, Muir KW, Annis IE, Sayner R, Romero MS, Adjei AA, Tudor G, Garcia N, Robin AL. Impact of a pre-visit glaucoma video/question prompt list intervention on Black patient eye drop adherence during a 12-month period: A randomized controlled trial. Optom Vis Sci. 2025 Oct 1;102(10):670-678. doi: 10.1097/OPX.0000000000002293.
PubMed 40857731Sleath B, Carpenter DM, Davis SA, Budenz DL, Muir KW, Romero MS, Lee C, Tudor G, Garcia N, Adjei AA, Robin AL. Improving Black Patient Question-Asking and Provider Education During Glaucoma Visits. Ophthalmol Glaucoma. 2023 Mar-Apr;6(2):206-214. doi: 10.1016/j.ogla.2022.09.003. Epub 2022 Sep 19.
PubMed 36967704Sleath B, Carpenter DM, Budenz DL, Muir KW, Romero MS, Tudor G, Garcia N, Adjei AA, Robin AL. Provider use of a participatory decision-making style with African American patients with glaucoma. Patient Educ Couns. 2023 Jun;111:107679. doi: 10.1016/j.pec.2023.107679. Epub 2023 Feb 20.
PubMed 36848727Sleath B, Carpenter DM, Davis SA, Budenz DL, Muir KW, Romero MS, Lee C, Tudor G, Garcia N, Adjei AA, Robin AL. Acceptance of a Pre-visit Intervention to Engage African American Glaucoma Patients during Visits. Optom Vis Sci. 2022 Dec 1;99(12):838-843. doi: 10.1097/OPX.0000000000001959. Epub 2022 Nov 26.
PubMed 36594752
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving African American Glaucoma Patient Involvement in Visits and Outcomes
- ClinicalTrials.gov ID
- NCT03657147
- Acronym / sponsor ID
- 17-0688
- Conditions
- Glaucoma
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 189 participants (actual)
- Lead sponsor
- University of North Carolina, Chapel HillUniversity, hospital or other
- Collaborators
- Agency for Healthcare Research and Quality (AHRQ)
- Study start
- 10 Sep 2018 (actual)
- Primary completion
- 12 Aug 2022 (actual)
- Study completion
- 12 Aug 2022 (actual)
- First posted
- 4 Sep 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Question Prompt List and Video | Experimental | Behavioral: Educational Video and Question Prompt ListParticipants 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. |
| Usual Care | No intervention | –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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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)
Key exclusion criteria (1 listed)
- < 18 years of age
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Educational Video and Question Prompt ListA 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. | Behavioural | Question Prompt List and Video |
Primary outcome
Intraocular Pressure
Time frame: 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
Time frame: 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
Time frame: 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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jun 2023.
- Derived from this study: PubMed 40857731Sleath B, Carpenter DM, Budenz DL, Muir KW, Annis IE, Sayner R, Romero MS, Adjei AA, Tudor G, Garcia N, Robin AL. Impact of a pre-visit glaucoma video/question prompt list intervention on Black patient eye drop adherence during a 12-month period: A randomized controlled trial. Optom Vis Sci. 2025 Oct 1;102(10):670-678. doi: 10.1097/OPX.0000000000002293.
- Derived from this study: PubMed 36967704Sleath B, Carpenter DM, Davis SA, Budenz DL, Muir KW, Romero MS, Lee C, Tudor G, Garcia N, Adjei AA, Robin AL. Improving Black Patient Question-Asking and Provider Education During Glaucoma Visits. Ophthalmol Glaucoma. 2023 Mar-Apr;6(2):206-214. doi: 10.1016/j.ogla.2022.09.003. Epub 2022 Sep 19.
- Derived from this study: PubMed 36848727Sleath B, Carpenter DM, Budenz DL, Muir KW, Romero MS, Tudor G, Garcia N, Adjei AA, Robin AL. Provider use of a participatory decision-making style with African American patients with glaucoma. Patient Educ Couns. 2023 Jun;111:107679. doi: 10.1016/j.pec.2023.107679. Epub 2023 Feb 20.
- Derived from this study: PubMed 36594752Sleath B, Carpenter DM, Davis SA, Budenz DL, Muir KW, Romero MS, Lee C, Tudor G, Garcia N, Adjei AA, Robin AL. Acceptance of a Pre-visit Intervention to Engage African American Glaucoma Patients during Visits. Optom Vis Sci. 2022 Dec 1;99(12):838-843. doi: 10.1097/OPX.0000000000001959. Epub 2022 Nov 26.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Betsy Sleath, PhD principal investigator
University of North Carolina, Chapel Hill
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Educational Video and Question Prompt List in people with Glaucoma, run by University of North Carolina, Chapel Hill at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Intraocular Pressure (time frame: 12 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03657147, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jun 2023.