GlaucomaGOALNCT03159481
Glaucoma Management Optimism for African Americans Living With Glaucoma
A study of Glaucoma, run by University of Alabama at Birmingham at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Glaucoma
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 441 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Jul 2018to 31 Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 12Show fewer
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Glaucoma
- Being tested
- Usual Care + Health Promotion Intervention
- Medical subject headings
- Glaucoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Usual Care + Health Promotion InterventionBehavioural
Also called GOAL
Telephone sessions for approximately 5-6 weeks to enhance empowerment and skills for managing medication adherence.
| Study group | Role | What they receive |
|---|---|---|
| Usual Care + Health Promotion Intervention | Experimental | Usual glaucoma care along with telehealth-based brief culturally informed health promotion intervention Receives: Behavioral: Usual Care + Health Promotion Intervention |
| Usual Care Only | No intervention | Usual glaucoma management only, no intervention. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Baseline, 3, 7 months, and 1 year
Secondary outcomes (5)
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.
Measured: 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.
Measured: 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'.
Measured: 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.
Measured: 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.
Measured: Baseline, 3, 7 months, and 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2017
- Study start13 Jul 2018
- Primary completion31 Dec 2022
- Study completion31 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GlaucomaStudies of the same condition, open and under way.
- More trials run by University of Alabama at BirminghamThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 441 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alabama at Birmingham
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Laura E. Dreer, PhD, University of Alabama at Birmingham
- Investigators
- Laura Dreer, Ph.D., Principal investigator, University of Alabama at Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03159481
- Sponsor's protocol ID
- 9070592
- Acronym
- GOAL
- Status last verified
- Apr 2023
- First submitted
- 16 May 2017
- Last updated
- 1 May 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Enhancing Glaucoma Medication Adherence Among African Americans
- ClinicalTrials.gov ID
- NCT03159481
- Acronym / sponsor ID
- GOAL / 9070592
- Conditions
- Glaucoma
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 441 participants (actual)
- Lead sponsor
- University of Alabama at BirminghamUniversity, hospital or other
- Study start
- 13 Jul 2018 (actual)
- Primary completion
- 31 Dec 2022 (actual)
- Study completion
- 31 Dec 2022 (actual)
- First posted
- 18 May 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Usual Care + Health Promotion Intervention | Experimental | Behavioral: Usual Care + Health Promotion InterventionUsual glaucoma care along with telehealth-based brief culturally informed health promotion intervention |
| Usual Care Only | No intervention | –Usual glaucoma management only, no intervention. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- 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
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Usual Care + Health Promotion InterventionAlso: GOALTelephone sessions for approximately 5-6 weeks to enhance empowerment and skills for managing medication adherence. | Behavioural | Usual Care + Health Promotion Intervention |
Primary outcome
Change in medication rate adherence via an electronic dosing aid
Time frame: Baseline, 3, 7 months, and 1 year
Assessment in medication adherence will be obtained via an electronic dosing aid which tracks medication behavior (e.g., attempts to dispense eye drops).
5 secondary outcomes
Knowledge of glaucoma management
Time frame: Baseline, 3, 7 months, and 1 year
Glaucoma symptoms
Time frame: Baseline, 3, 7 months, and 1 year
Health beliefs and illness perception
Time frame: Baseline, 3, 7 months, and 1 year
Social problem-solving skills
Time frame: Baseline, 3, 7 months, and 1 year
Depressive symptomatology
Time frame: Baseline, 3, 7 months, and 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2023.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Laura Dreer, Ph.D. principal investigator
University of Alabama at Birmingham
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study of Glaucoma, run by University of Alabama at Birmingham at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in medication rate adherence via an electronic dosing aid (time frame: Baseline, 3, 7 months, and 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 May 2023.