Glaucoma Management Optimism for African Americans Living With Glaucoma (GOAL)

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.

Study Overview

• Status: Completed
• Conditions: Glaucoma
• Intervention / Treatment: Behavioral: Usual Care + Health Promotion Intervention

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.

• Study Type: Interventional
• Enrollment (Actual): 441
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Birmingham, Alabama, United States, 35294
      • UAB

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Usual Care + Health Promotion Intervention; Usual glaucoma care along with telehealth-based brief culturally informed health promotion intervention	Behavioral: Usual Care + Health Promotion Intervention; Telephone sessions for approximately 5-6 weeks to enhance empowerment and skills for managing medication adherence.; Other Names: GOAL
No Intervention: Usual Care Only; Usual glaucoma management only, no intervention.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in medication rate adherence via an electronic dosing aid	Assessment in medication adherence will be obtained via an electronic dosing aid which tracks medication behavior (e.g., attempts to dispense eye drops).	Baseline, 3, 7 months, and 1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Knowledge of glaucoma management	This is an 11-item self-report measure of Patient Satisfaction with Glaucoma Treatment (Glaustat) that will be used to understand patients' knowledge of glaucoma and its management.	Baseline, 3, 7 months, and 1 year
Glaucoma symptoms	The investigators will use the Glaucoma Symptom Scale to assess visual and nonvisual symptoms which developed from a modified version of a checklist used in the Ocular Hypertension Treatment Study. It has 10 items that ask respondents whether they have experienced certain symptoms (e.g., dryness) in the prior 4 weeks and to what extent they were bothered by these symptoms.	Baseline, 3, 7 months, and 1 year
Health beliefs and illness perception	The 18-item Beliefs about Medicines Questionnaire (BMQ) will be used to assess patients' concerns about present/potential future adverse effects from their medications and their beliefs regarding the necessity of their medications. Scores are summed within each scale to create an overall scale score (range: 8-40 for a 'necessity scale' and 10-50 for a 'concerns scale'.	Baseline, 3, 7 months, and 1 year
Social problem-solving skills	The Social Problem-Solving Inventory-Revised is a 25-item, self-report measure of motivation for solving problems and problem-solving abilities. The SPSI-R is based on a five dimensional model of problem-solving ability which includes two theoretically defined components, both of which will be measured: problem orientation and problem-solving skills.	Baseline, 3, 7 months, and 1 year
Depressive symptomatology	The investigators will use the nine items of the Patient Health Questionnaire-9 (PHQ-9) scale to assess depressive symptomatology. The total score is calculated by summing each of the PHQ-9 items with higher scores indicating the presence of greater depressive symptomatology. The criterion, construct and external validity of the PHQ-9 have been well established using large medical samples.	Baseline, 3, 7 months, and 1 year

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sociodemographic variables	The investigators will evaluate the influence of several sociodemographic factors on outcomes (e.g., gender, income).	Baseline, 3, 7 months, and 1 year
Medical factors	The investigators will also characterize ocular variables and other health related factors (e.g., intraocular pressure, degree of field loss, other medical conditions.	Baseline, 3, 7 months, and 1 year

Collaborators and Investigators

• Sponsor: University of Alabama at Birmingham

Study record dates

Study Major Dates

• Study Start (Actual): July 13, 2018
• Primary Completion (Actual): December 31, 2022
• Study Completion (Actual): December 31, 2022

Study Registration Dates

• First Submitted: May 16, 2017
• First Submitted That Met QC Criteria: May 17, 2017
• First Posted (Actual): May 18, 2017

Study Record Updates

• Last Update Posted (Actual): May 1, 2023
• Last Update Submitted That Met QC Criteria: April 28, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Ocular Hypertension; Glaucoma
• Other Study ID Numbers: 9070592

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes