Glaucoma Management Optimism for African Americans Living With Glaucoma

NCT03159481 | Completed DMC

• 1 other identifier: 9070592
• Study Type: interventional
• Target: 441
• Locations: 1 country
• Sites: 1

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.

Conditions

Glaucoma

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Knowledge of glaucoma management

  Baseline, 3, 7 months, and 1 year

• Glaucoma symptoms

  Baseline, 3, 7 months, and 1 year

• Health beliefs and illness perception

  Baseline, 3, 7 months, and 1 year

• Social problem-solving skills

  Baseline, 3, 7 months, and 1 year

• Depressive symptomatology

  Baseline, 3, 7 months, and 1 year

Other Outcomes (2)

• Sociodemographic variables

  Baseline, 3, 7 months, and 1 year

• Medical factors

  Baseline, 3, 7 months, and 1 year

Study Arms (2)

Usual Care + Health Promotion Intervention

EXPERIMENTAL

Usual glaucoma care along with telehealth-based brief culturally informed health promotion intervention

Behavioral: Usual Care + Health Promotion Intervention

Usual Care Only

NO INTERVENTION

Usual glaucoma management only, no intervention.

Interventions

Usual Care + Health Promotion Intervention BEHAVIORAL

Telephone sessions for approximately 5-6 weeks to enhance empowerment and skills for managing medication adherence.

Also known as: GOAL

Usual Care + Health Promotion Intervention

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• age ≥ 21 years old
• have one of the following diagnoses: open-angle glaucoma, angle-closure glaucoma, glaucoma suspect, or ocular hypertension (OHTN) in one or both eyes
• using or prescribed a topical prostaglandin analog
• not to have undergone past laser or surgical glaucoma therapy within 3 months before the study
• have two reliable visual fields over the past 2 years
• English-speaking
• cognitively oriented as defined by the Six-Item Screener (SIS) score of \> 4 of 6
• have access to a telephone,
• agrees to random assignment to either arm of study
• agrees to return for all follow-up visits
• patient has been determined to be 80% or less adherent.

You may not qualify if:

• cognitively unable to understand the study
• does not instill their own eye drops
• incapable of using the electronic MEMS bottle/cap after a brief practice session
• known contraindications to Travoprost
• has a severe hearing impairment impeding communication.

Sponsors & Collaborators

• University of Alabama at Birmingham: lead

Study Sites (1)

UAB

Birmingham, Alabama, 35294, United States

Location

MeSH Terms

Conditions

Glaucoma

Condition Hierarchy (Ancestors)

Ocular Hypertension; Eye Diseases

Study Officials

• Laura Dreer, Ph.D.

  University of Alabama at Birmingham

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: May 16, 2017
• First Posted: May 18, 2017
• Study Start: July 13, 2018
• Primary Completion: December 31, 2022
• Study Completion: December 31, 2022
• Last Updated: May 1, 2023

Record last verified: 2023-04

Locations

US (1)