Ignite Creation Date:
2024-05-06 @ 10:05 AM
Last Modification Date:
2024-10-26 @ 12:24 PM
Study NCT ID:
NCT03159481
Status:
COMPLETED
Last Update Posted:
2023-05-01
First Post:
2017-05-16
Brief Title:
Glaucoma Management Optimism for African Americans Living With Glaucoma
Sponsor:
University of Alabama at Birmingham
Organization:
University of Alabama at Birmingham
Study Overview
Official Title:
Enhancing Glaucoma Medication Adherence Among African Americans
Status:
COMPLETED
Status Verified Date:
2023-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
GOAL
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 andor 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 AAs 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 administrationscheduling 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
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 AAs 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 administrationscheduling 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 AAs 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 AAs 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
Aim 2 To longitudinally examine the associations between medical demographic cultural socioeconomic and ocular factors and objective medication adherence rates among AAs 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 AAs 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?:
None