Clinical trial NCT03159481: Glaucoma Management Optimism for African Americans Living With Glaucoma
Official title: Enhancing Glaucoma Medication Adherence Among African Americans
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Glaucoma
Lead sponsor: University of Alabama at Birmingham
Sponsor class: OTHER
First posted: 2017-05-18
Enrollment: 441
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed description: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change in medication rate adherence via an electronic dosing aid
timeFrame: Baseline, 3, 7 months, and 1 year
Secondary outcomes:
measure: Knowledge of glaucoma management
timeFrame: Baseline, 3, 7 months, and 1 year
measure: Glaucoma symptoms
timeFrame: Baseline, 3, 7 months, and 1 year
measure: Health beliefs and illness perception
timeFrame: Baseline, 3, 7 months, and 1 year
measure: Social problem-solving skills
timeFrame: Baseline, 3, 7 months, and 1 year
measure: Depressive symptomatology
timeFrame: Baseline, 3, 7 months, and 1 year
Other outcomes:
measure: Sociodemographic variables
timeFrame: Baseline, 3, 7 months, and 1 year
measure: Medical factors
timeFrame: Baseline, 3, 7 months, and 1 year
Locations:
city: Birmingham
country: United States
facility: UAB
state: Alabama
Study officials:
affiliation: University of Alabama at Birmingham
name: Laura Dreer, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: