Glaucoma Management Optimism for African Americans Living With Glaucoma
NCT03159481 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 441
Last updated 2023-05-01
Summary
African Americans (AA) are at higher risk to develop and go blind from glaucoma than Caucasians. While glaucoma medications can help delay disease progression and possible blindness, problems with poor adherence have been documented for both racial groups, with a greater prevalence among AA. Of the very few interventions targeting glaucoma medication adherence studied to date, several methodological limitations persist. For example, few have been subjected to rigorous randomized clinical trial (RCT) designs, the intervention itself was designed and studied predominantly among Caucasians and thereby limiting generalizability, the effects on adherence have been short-term, most have been evaluated on small sample sizes, and/or the focus of the intervention was solely on providing patient education regarding eye disease and management. Needed in this important yet understudied area are culturally-relevant, health promotion-based approaches which are 1) targeted to high risk populations, 2) theoretically driven, 3) relevant to the beliefs, language, and values of underserved populations as well as challenges related to glaucoma medication adherence, 4) designed to promote preparation and readiness to engage in healthy behaviors, and 5) train patients in skills to use in order to more effectively problem-solve ongoing obstacles related to adherence.
The investigators published a paper in the Journal of Glaucoma investigating determinants related to objective medication adherence as measured by an electronic dosing aid (DA). Findings revealed poorer rates of adherence among AA patients with glaucoma compared to Caucasian patients with glaucoma. Evidence for racial differences in adherence have also been increasingly documented in the glaucoma literature. In a follow-up study with focus groups of AA's with glaucoma that was published in Optometry and Vision Sciences, the goal was to identify the specific barriers and facilitators related to glaucoma medication adherence among this high-risk group. Several key themes emerged such as patient, provider, and socioeconomic factors, along with barriers in views of health, perceived harm from treatment, costs, avoidant coping styles, forgetfulness, and in eyedrop administration/scheduling. The investigators used these results along with guidance from a consumer advisory board consisting of AA patients with glaucoma in order to develop and pilot test the resulting culturally relevant, health promotion-based intervention. The pilot data demonstrated feasibility and favorable preliminary efficacy for the intervention to significantly improve medication adherence to further pursue in a clinical trial.
Conditions
Interventions
- BEHAVIORAL
-
Usual Care + Health Promotion Intervention
Telephone sessions for approximately 5-6 weeks to enhance empowerment and skills for managing medication adherence.
Sponsors & Collaborators
-
University of Alabama at Birmingham
lead OTHER
Principal Investigators
-
Laura Dreer, Ph.D. · University of Alabama at Birmingham
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- SINGLE
- Model
- PARALLEL
Eligibility
- Min Age
- 21 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2018-07-13
- Primary Completion
- 2022-12-31
- Completion
- 2022-12-31
Countries
- United States
Study Locations
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