Glaucoma Management Optimism for African Americans Living With Glaucoma
| Status: | Recruiting |
|---|---|
| Conditions: | Ocular |
| Therapuetic Areas: | Ophthalmology |
| Healthy: | No |
| Age Range: | 21 - Any |
| Updated: | 9/15/2018 |
| Start Date: | July 13, 2018 |
| End Date: | May 31, 2020 |
| Contact: | Laura Dreer, Ph.D. |
| Email: | laurdreer@uabmc.edu |
| Phone: | (205) 325-8681 |
Enhancing Glaucoma Medication Adherence Among African Americans
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.
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.
Aim 1: To evaluate the efficacy of a culturally relevant, health promotion-based intervention
to increase rates of glaucoma medication adherence among AA patients with glaucoma as
compared to usual care.
Aim 2: To longitudinally examine the associations between medical, demographic, cultural,
socioeconomic, and ocular factors and objective medication adherence rates among AA's with
glaucoma in the usual care only group. This aim will explore what factors are associated with
glaucoma medication adherence, as defined by objective adherence measures, during usual care.
This information will facilitate hypothesis generation and testing for future studies.
Aim 3: To longitudinally examine the associations between medical, demographic, cultural,
socioeconomic, and ocular factors and objective medication adherence rates among AA's with
glaucoma in the treatment arm (those receiving the treatment intervention). This aim will
explore what patient-related factors are more or less likely to relate to the effectiveness
of the intervention as defined by objective adherence. This information is useful for
understanding which patients may ultimately most responsive to the intervention.
to increase rates of glaucoma medication adherence among AA patients with glaucoma as
compared to usual care.
Aim 2: To longitudinally examine the associations between medical, demographic, cultural,
socioeconomic, and ocular factors and objective medication adherence rates among AA's with
glaucoma in the usual care only group. This aim will explore what factors are associated with
glaucoma medication adherence, as defined by objective adherence measures, during usual care.
This information will facilitate hypothesis generation and testing for future studies.
Aim 3: To longitudinally examine the associations between medical, demographic, cultural,
socioeconomic, and ocular factors and objective medication adherence rates among AA's with
glaucoma in the treatment arm (those receiving the treatment intervention). This aim will
explore what patient-related factors are more or less likely to relate to the effectiveness
of the intervention as defined by objective adherence. This information is useful for
understanding which patients may ultimately most responsive to the intervention.
Inclusion Criteria:
1. age ≥ 21 years old
2. AA
3. have one of the following diagnoses: open-angle glaucoma, angle-closure glaucoma,
glaucoma suspect, or ocular hypertension (OHTN) in one or both eyes
4. using or prescribed a topical prostaglandin analog
5. not to have undergone past laser or surgical glaucoma therapy within 3 months before
the study
6. have two reliable visual fields over the past 2 years
7. English-speaking
8. cognitively oriented as defined by the Six-Item Screener (SIS) score of > 4 of 6
9. have access to a telephone,
10. agrees to random assignment to either arm of study
11. agrees to return for all follow-up visits
12. patient has been determined to be 80% or less adherent.
Exclusion Criteria:
1. cognitively unable to understand the study
2. does not instill their own eye drops
3. incapable of using the electronic MEMS bottle/cap after a brief practice session
4. known contraindications to Travoprost
5. has a severe hearing impairment impeding communication.
We found this trial at
1
site
