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

Primary Purpose

Glaucoma

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Usual Care + Health Promotion Intervention
Sponsored by
University of Alabama at Birmingham
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Glaucoma

Eligibility Criteria

21 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • UAB

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Usual Care + Health Promotion Intervention

Usual Care Only

Arm Description

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

Usual glaucoma management only, no intervention.

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

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.
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.
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'.
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.
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.

Full Information

First Posted
May 16, 2017
Last Updated
April 28, 2023
Sponsor
University of Alabama at Birmingham
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1. Study Identification

Unique Protocol Identification Number
NCT03159481
Brief Title
Glaucoma Management Optimism for African Americans Living With Glaucoma
Acronym
GOAL
Official Title
Enhancing Glaucoma Medication Adherence Among African Americans
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Completed
Study Start Date
July 13, 2018 (Actual)
Primary Completion Date
December 31, 2022 (Actual)
Study Completion Date
December 31, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Alabama at Birmingham

4. Oversight

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
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Glaucoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
441 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Usual Care + Health Promotion Intervention
Arm Type
Experimental
Arm Description
Usual glaucoma care along with telehealth-based brief culturally informed health promotion intervention
Arm Title
Usual Care Only
Arm Type
No Intervention
Arm Description
Usual glaucoma management only, no intervention.
Intervention Type
Behavioral
Intervention Name(s)
Usual Care + Health Promotion Intervention
Other Intervention Name(s)
GOAL
Intervention Description
Telephone sessions for approximately 5-6 weeks to enhance empowerment and skills for managing medication adherence.
Primary Outcome Measure Information:
Title
Change in medication rate adherence via an electronic dosing aid
Description
Assessment in medication adherence will be obtained via an electronic dosing aid which tracks medication behavior (e.g., attempts to dispense eye drops).
Time Frame
Baseline, 3, 7 months, and 1 year
Secondary Outcome Measure Information:
Title
Knowledge of glaucoma management
Description
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.
Time Frame
Baseline, 3, 7 months, and 1 year
Title
Glaucoma symptoms
Description
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.
Time Frame
Baseline, 3, 7 months, and 1 year
Title
Health beliefs and illness perception
Description
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'.
Time Frame
Baseline, 3, 7 months, and 1 year
Title
Social problem-solving skills
Description
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.
Time Frame
Baseline, 3, 7 months, and 1 year
Title
Depressive symptomatology
Description
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.
Time Frame
Baseline, 3, 7 months, and 1 year
Other Pre-specified Outcome Measures:
Title
Sociodemographic variables
Description
The investigators will evaluate the influence of several sociodemographic factors on outcomes (e.g., gender, income).
Time Frame
Baseline, 3, 7 months, and 1 year
Title
Medical factors
Description
The investigators will also characterize ocular variables and other health related factors (e.g., intraocular pressure, degree of field loss, other medical conditions.
Time Frame
Baseline, 3, 7 months, and 1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: age ≥ 21 years old AA 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. Exclusion Criteria: 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Laura Dreer, Ph.D.
Organizational Affiliation
University of Alabama at Birmingham
Official's Role
Principal Investigator
Facility Information:
Facility Name
UAB
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35294
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Glaucoma Management Optimism for African Americans Living With Glaucoma

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