NCT03657147

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
189

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2018

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 28, 2018

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 4, 2018

Completed
6 days until next milestone

Study Start

First participant enrolled

September 10, 2018

Completed
3.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 12, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 12, 2022

Completed
Last Updated

June 29, 2023

Status Verified

June 1, 2023

Enrollment Period

3.9 years

First QC Date

August 28, 2018

Last Update Submit

June 27, 2023

Conditions

Glaucoma

Outcome Measures

Primary Outcomes (3)

  • 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

Study Arms (2)

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.

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.

Interventions

Educational Video and Question Prompt ListBEHAVIORAL

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.

Question Prompt List and Video

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • \< 18 years of age

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, 27599, United States

Location

Related Publications (3)

  • Sleath 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.

    PMID: 36967704DERIVED

  • Sleath 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.

    PMID: 36848727DERIVED

  • Sleath 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.

    PMID: 36594752DERIVED

MeSH Terms

Conditions

Glaucoma

Condition Hierarchy (Ancestors)

Ocular HypertensionEye Diseases

Study Officials

  • Betsy Sleath, PhD

    University of North Carolina, Chapel Hill

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 28, 2018

First Posted

September 4, 2018

Study Start

September 10, 2018

Primary Completion

August 12, 2022

Study Completion

August 12, 2022

Last Updated

June 29, 2023

Record last verified: 2023-06

Data Sharing

IPD Sharing
Will not share

Locations

US(1)